Introduction
Methods
Search strategy and eligibility criteria
Study selection and data collection process
Level type of evidence |
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1A: Systematic review (with homogeneity) of RCTs |
1B: Individual RCT (with narrow confidence intervals) |
1C: All or none study |
2A: Systematic review (with homogeneity) of cohort studies |
2B: Individual Cohort study (including low quality RCT, e.g., < 80% follow-up) |
2C: “Outcomes” research; Ecological studies |
3A: Systematic review (with homogeneity) of case–control studies |
3B: Individual Case–control study |
4: Case series and poor-quality cohort and case–control study |
5: Expert opinion without explicit critical appraisal or based on physiology bench research or “first principles” |
Results
Identification of studies
Levels of evidence and methodological quality
Study | Title | Evidence Level | Downs and Black Tool | ||||||
---|---|---|---|---|---|---|---|---|---|
Subsections | Total Score | ||||||||
Reporting | External Validity | Internal Validity: Bias | Internal Validity: Confounding | Power | |||||
1 | Chang et al. 2018 | Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: A pilot randomized study | 2B | 7 | 2 | 5 | 4 | 0 | 18 (Moderate) |
2 | Tsai et al. 2020 | Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study | 3B | 10 | 0 | 3 | 2 | 0 | 15 (Moderate) |
3 | Asselin et al. 2015 | Heart Rate and Oxygen demand of Powered Exoskeleton-Assisted Walking in person with paraplegia | 2B | 8 | 3 | 3 | 0 | 0 | 14 (Moderate) |
4 | Gagnon et al. 2018 (A) | Locomotor training using an overground robotic exoskeleton in long-term manual wheelchair users with a chronic spinal cord injury living in the community: Lessons learned from a feasibility study in terms of recruitment, attendance, learnability, performance and safety | 2B | 8 | 3 | 3 | 0 | 0 | 14 (Moderate) |
5 | Khan et al. 2019 | Retraining walking over ground in a powered exoskeleton after spinal cord injury: a prospective cohort study to examine functional gains and neuroplasticity | 2B | 9 | 1 | 3 | 1 | 0 | 14 (Moderate) |
6 | Platz et al. 2016 | Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction | 2B | 8 | 3 | 3 | 0 | 0 | 14 (Moderate) |
7 | Baunsgaard et al. 2018 (A) | Gait training after spinal cord injury: safety, feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics | 2B | 8 | 1 | 3 | 1 | 0 | 13 (Moderate) |
8 | Baunsgaard et al. 2018 (B) | Exoskeleton gait training after spinal cord injury: An exploratory study on secondary health conditions | 2B | 8 | 1 | 3 | 1 | 0 | 13 (Moderate) |
9 | van Dijsseldonk et al. 2019 | Predictors of exoskeleton motor learning in spinal cord injured patients | 2B | 7 | 2 | 3 | 1 | 0 | 13 (Moderate) |
10 | Chun et al. 2020 | Changes in Bowel Function Following Exoskeletal-Assisted Walking in Persons with Spinal Cord Injury: An Observational Pilot Study | 2B | 7 | 3 | 2 | 0 | 0 | 12 (Moderate) |
11 | Tefertiller et al. 2018 | Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury | 2B | 8 | 1 | 3 | 0 | 0 | 12 (Moderate) |
12 | Yang et al. 2015 | Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury | 2B | 8 | 1 | 3 | 0 | 0 | 12 (Moderate) |
13 | Yatsugi et al. 2018 | Feasibility of Neurorehabilitation Using a Hybrid Assistive Limb for Patients Who Underwent Spine Surgery | 2B | 7 | 2 | 3 | 0 | 0 | 12 (Moderate) |
14 | Benson et al. 2016 | Lower-limb exoskeletons for individuals with chronic spinal cord injury: Findings from a feasibility study | 2B | 6 | 3 | 2 | 0 | 0 | 11 (Moderate) |
15 | Escalona et al. 2018 | Cardiorespiratory demand and rate of perceived exertion during overground walking with a robotic exoskeleton in long-term manual wheelchair users with chronic spinal cord injury: A cross-sectional study | 2B | 7 | 1 | 3 | 0 | 0 | 11 (Moderate) |
16 | Fineberg et al. 2013 | Vertical ground reaction force-based analysis of powered exoskeleton-assisted walking in persons with motor-complete paraplegia | 2B | 7 | 1 | 3 | 0 | 0 | 11 (Moderate) |
17 | Guanziroli et al. 2019 | Assistive powered exoskeleton for complete spinal cord injury: correlations between walking ability and exoskeleton control | 3B | 7 | 1 | 3 | 0 | 0 | 11 (Moderate) |
18 | Kubota et al. 2019 | Hybrid assistive limb (HAL) treatment for patients with severe thoracic myelopathy due to ossification of the posterior longitudinal ligament (OPLL) in the postoperative acute/subacute phase: A clinical trial | 2B | 8 | 0 | 3 | 0 | 11 (Moderate) | |
19 | Sale et al. 2016 (A) | Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: A preliminary report | 4 | 8 | 0 | 3 | 0 | 0 | 11 (Moderate) |
20 | Stampacchia et al. 2016 | Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons | 2B | 7 | 1 | 3 | 0 | 0 | 11 (Moderate) |
21 | Zeilig et al. 2012 | Safety and tolerance of the ReWalkTM exoskeleton suit for ambulation by people with complete spinal cord injury: A pilot study | 4 | 7 | 1 | 3 | 0 | 0 | 11 (Moderate) |
22 | Alamro et al. 2018 | Overground walking with a robotic exoskeleton elicits trunk muscle activity in people with high-thoracic motor-complete spinal cord injury | 3B | 7 | 0 | 3 | 0 | 0 | 10 (Poor) |
23 | Esquenazi et al. 2012 | The ReWalk Powered Exoskeleton to Restore Ambulatory Function to Individuals with Thoracic-Level Motor-Complete Spinal Cord Injury | 2B | 7 | 0 | 2 | 1 | 0 | 10 (Poor) |
24 | Juszczak et al. 2018 | Examining the Effects of a Powered Exoskeleton on Quality of Life and Secondary Impairments in People Living With Spinal Cord Injury | 2B | 6 | 1 | 3 | 0 | 0 | 10 (Poor) |
25 | Karelis et al. 2017 | Effect on body composition and bone mineral density of walking with a robotic exoskeleton in adults with chronic spinal cord injury | 2B | 7 | 0 | 3 | 0 | 0 | 10 (Poor) |
26 | Kozlowski et al. 2015 | Time and effort required by persons with spinal cord injury to learn to use a powered exoskeleton for assisted walking | 2B | 7 | 1 | 2 | 0 | 0 | 10 (Poor) |
27 | McIntosh et al. 2020 | The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury | 4 | 6 | 1 | 3 | 0 | 0 | 10 (Poor) |
28 | Ramanujam et al. 2018 (A) | Neuromechanical adaptations during a robotic powered exoskeleton assisted walking session | 3B | 7 | 0 | 3 | 0 | 0 | 10 (Poor) |
29 | Sale et al. 2018 (B) | Training for mobility with exoskeleton robot in spinal cord injury patients: a pilot study | 2B | 7 | 0 | 3 | 0 | 0 | 10 (Poor) |
30 | Birch et al. 2017 | Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid | 2B | 7 | 1 | 1 | 0 | 0 | 9 (Poor) |
31 | Evans et al. 2015 | Acute Cardiorespiratory and Metabolic Responses During Exoskeleton-Assisted Walking Overground Among Persons with Chronic Spinal Cord Injury | 2B | 6 | 0 | 3 | 0 | 0 | 9 (Poor) |
32 | Gagnon et al. 2019 (B) | Satisfaction and perceptions of long-term manual wheelchair users with a spinal cord injury upon completion of a locomotor training program with an overground robotic exoskeleton | 2B | 6 | 0 | 3 | 0 | 0 | 9 (Poor) |
33 | Hartigan et al. 2015 | Mobility outcomes following five training sessions with a powered exoskeleton | 2B | 6 | 1 | 2 | 0 | 0 | 9 (Poor) |
34 | Lonini et al. 2016 | Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study | 3B | 5 | 1 | 3 | 0 | 0 | 9 (Poor) |
35 | Ramanujam et al. 2018 (B) | Mechanisms for improving walking speed after longitudinal powered robotic exoskeleton training for individuals with spinal cord injury | 3B | 6 | 0 | 3 | 0 | 0 | 9 (Poor) |
36 | Kressler et al. 2014 (A) | Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury | 4 | 6 | 0 | 2 | 0 | 0 | 8 (Poor) |
37 | Kolakowsky-Hayner et al. 2013 | Safety and Feasibility of using the EksoTM Bionic Exoskeleton to Aid Ambulation after Spinal Cord Injury | 2B | 5 | 1 | 1 | 0 | 7 (Poor) | |
38 | Kressler et al. 2019 (B) | Cardiometabolic Challenges Provided by Variable Assisted Exoskeletal Versus Overground Walking in Chronic Motor-incomplete Paraplegia: A Case Series | 4 | 5 | 0 | 2 | 0 | 0 | 7 (Poor) |
39 | Manns et al. 2019 | Perspectives of people with spinal cord injury learning to walk using a powered exoskeleton | 2B | 5 | 0 | 1 | 0 | 0 | 6 (Poor) |
40 | Talaty et al. 2013 | Differentiating ability in users of the ReWalk(TM) powered exoskeleton: an analysis of walking kinematics | 3B | 3 | 0 | 0 | 0 | 0 | 3 (Poor) |
41 | Cahill et al. 2018 | Gym-based exoskeleton walking: A preliminary exploration of non-ambulatory end-user perspectives | 4 | 2 | 0 | 0 | 0 | 0 | 2 (Poor) |
Participants
Study (D&B total score) | Number of participants (Sex) | Individuals features | Exoskeleton Intervention | Comparison Intervention | Evaluations | Follow-up | Drop out | ||
---|---|---|---|---|---|---|---|---|---|
Exoskeleton: Ekso | |||||||||
Subacute | n-RCT | Tsai et al. 2020 (15) | 30 (24 M, 6F) | LOI: C-T-L AIS A(3), B(3), C(13), D(11) Age: mean 46.8 years (intervention group), mean 52 years (control group) TSI: mean 21.3 days (intervention group), mean 17.4 days (control group) | Part of minimum 15 h of CPT x week | CPT | Each session: up time, walk time, steps (reported as mean across all training sessions) Pre and Post training: UEMS, LEMS, FIM | NP | NR |
McIntosh et al. 2020 (10) | 11 (8 M, 3F) | LOI: C6-L2 AIS A(5), C(5), D(1) Age: mean 41 years TSI: 3–15 weeks | 1 h × 3 days/week × 25 sessions (in associaton with CPT) | NO | Each session: up time, walk time, steps number; Pre and Post each session: VAS_p; Sitting vs standing vs prior to sitting: BP, HR; Sitting, session mid-time, prior to resitting: BRPE (1–10); Sessions 2, 13, 25: 6MWT, 10MWT | NP | 1 | ||
Chronic | RCT | Chang et al. 2018 (18) | 7 (5 M, 2F) | LOI: C4-T12 AIS C(2), D(5) Age: mean 56 years intervention group), mean 60 years (control group) TSI: 15 years (intervention group), 7 years (control group) | 1 h × 5 days/week × 3 weeks | CPT | Pre and Post training: stride length, step length, cadence, 6MWT, 10MWT, LEMS, TUG | NP | 2 |
n-RCT | Gagnon et al. 2018 (A) (14) | 14 (9 M, 5F) | LOI: C6-T10 AIS A(14) Age: mean 38.7 years TSI: mean 7.4 years | 1 h × 3 days/week × 18 sessions | NO | Each session: up time, walk time, steps number, level of assistance provided by trained assistant during walking Pre and Post training: 10MWT | NP | 1 | |
Escalona et al. 2018 (11) | 13 (8 M, 5F) | LOI: C6-T10 AIS A(13) Age: mean 38.1 years TSI: mean 5.1 years | 2–3 days/week × 18 sessions | NO | Single evaluation at last session while sitting, standing, walking: VO2, VCO2, VE, VT, RER, RR, HR Single evaluation at last session after walking: BRPE (1–10) | NP | 0 | ||
Sale et al. 2016 (A) (11) | 3 (2 M, 1F) | LOI: T6-L1 AIS A(2), C(1) Age: mean 36 years TSI: Chronics | 50 min × 3–4 days/week × 20 sessions | NO | Pre and Post training: velocity, cadence, step width, step length, stance time, double support time, Satisfaction Questionnaire, 6MWT indoor, 6MWT outdoor, 10MWT, TUG, VAS_p, VAS fatigue, BRPE(1–10) | NP | 0 | ||
Alamro et al. 2018 (10) | 16 (8 ABs, 8 SCI) (11 M, 5F) | LOI: C7-T4 AIS A(6), B(2) Age: mean 38.7 years TSI: 1–25 years | 1 session: 3 walking conditions | Ekso-OG, Ekso on treadmill and Lokomat | Single evaluation: trunk muscle activation, trunk acceleration | NP | 0 | ||
Karelis et al. 2017 (10) | 5 (4 M, 1F) | LOI: C7-T10 AIS A(5) Age: mean 60.4 years TSI: mean 7.6 years | 1 h × 3 days/week × 6 weeks | NO | Pre and Post training: Body Weight, BMI, Total lean body mass, Arm lean body mass, Leg lean body mass, Appendicular lean body mass, Trunk lean body mass, Total fat mass, Arm fat mass, Leg fat mass, Appendicular fat mass, Trunk fat mass, Total bone mineral density, Leg bone mineral density, Tibia Bone mineral density, Cross-sectional area of the calf Muscle, Subcutaneous adipose tissue, Intramuscular adipose tissue | NP | 0 | ||
Ramanujam et al. 2018 (A) (10) | 8 (4 Abs, 4 SCI) (6 M, 2F) | LOI: C5-T10 AIS A(2), C(2) Age: mean 41.75 years (individuals with SCI) 27.25 years (ABs) TSI: 0.5–9.5 years | 1 session | AB: walking without Ekso at self-selected, fast and slow speeds and with Ekso in "Passive" and "Active" conditions | Single evaluation: walking velocity, stance time, swing time, mean knee and hip ROM, EMG lower limbs | NP | NR | ||
Gagnon et al. 2018 (B) (9) | 14 (9 M, 5F) | LOI: C6-T10 AIS A, B, C Age: mean 38.7 years TSI: mean 7.4 years | Questionnaire after 1 h × 2–3 days/week × 18 sessions | NO | Post training: questionnaire | NP | NR | ||
Ramanujam et al. 2018 (B) (9) | 12 (4 Abs, 8 SCI) (9 M, 3F) | LOI: C4-T11 AIS NR (incomplete) Age: mean 39.12 years TSI: mean 6.38 years | 3–4 days/week × 100 h | AB: walking with Ekso | Pre and Post training: stride time, step time, stance time, double support time, stride length, step length, step frequency, walking speed | NP | NR | ||
Kressler et al. 2014 (A) (8) | 3 (2 M, 1F) | LOI: T1-T10 AIS A(3) Age: mean 30.33 years TSI: ≥ 1 yr | 1 h × 3 days/week × 6 weeks | NO | Pre, Mid and Post training: 10MWT, 2MWT, SCATS, ISCIBPD, NRS_p, EMG, %VO2 peak, EE | NP | NR | ||
Kressler et al. 2019 (B) (7) | 2 (1 M, 1F) | LOI: T6-T12 AIS NR (incomplete) Age: mean 45 years TSI: 2–9 years | 1 session walking with Ekso and 1 session walking without Ekso | Overground walking | Single evaluation for each session: VO2, HR, EE | NP | NR | ||
Cahill et al. 2018 (2) | 4 (3 M, 1F) | LOI: NR AIS NR (2 complete, 2 incomplete) Age: mean 41 years TSI: mean 5 years | 13–25 months | NO | Post training: semi-structured interview | NP | NR | ||
Subacute + chronic | n-RCT | Baunsgaard et al. 2018 (A) (13) | 52 (36 M, 16F) | LOI: C1-L2 AIS A and B (36), C and D (16) Age: mean 35.8 years TSI: 0.2–10.8 years | 3 days/week × 8 weeks | NO | Each session: up time, walk time, steps number, BRPE(6–20) Pre, Mid and Post training: up time, walk time, steps number, 10MWT, TUG, BBS, WISCI II, LEMS, HR and BP (before and after 10 min of walking) | 4 weeks: LEMS, 10MWT, TUG, BBS, WISCI II | 8 |
Baunsgaard et al. 2018 (B) (13) | 52 (36 M, 16F) | LOI: C1-L2 AIS A and B (36), C and D (16) Age: mean 35.8 years TSI: 0.2–10.8 years | 20–60 min × 3 days/week × 8 weeks | NO | After each session, Pre, Mid and Post training: ISCIPBDS, MAS Pre and Post trainingt: hip, knee and ankle flexor/extensor ROM, SCIM III, ISCIBDS for bowel, bladder and QoL | 4 weeks: ROM, SCIM III, ISCIBDS for bowel, bladder and QoL | NR | ||
Stampacchia et al. 2016 (11) | 21 (17 M, 4F) | LOI: C7-L2 AIS A(12), B(2), D(7) Age: mean 48.1 years TSI: 2–330 months | 40 min × 1 session | NO | Pre and Post single session: MAS, PSFS, NRS_sp, NRS_p Post session: PGIC, ad hoc questionnaire for subjective experience | NP | NR | ||
Kozlowski et al. 2015 (10) | 7 (7 M) | LOI: C4-L1 AIS A(3), B(1), C(3) Age: mean 36 years TSI: 0.4–7.4 years | 2 h × 1–2 days/week x up to 24 sessions | NO | Number of sessions needed to achieve a rating of “minimal assistance” and to achieve “contact guard” for walking and stand/sit Each session (only best performance was reported): walk time, up time, steps number, walk distance during longest walk and 2MWT, donning/doffing assistance Sitting, session mid-time, after resitting: BP, HR, METs, BRPE(6–20) | NP | NR | ||
Kolakowsky-Hayner et al. 2013 (7) | 7 (5 M, 2F) | LOI: T4-T12 AIS A(7) Age: mean 29.8 years TSI: 65–578 days | 1 h × 1 day/week × 6 weeks | NO | Each session: up time, walk time, step length, distance, don/doff time, level of assistance provided by trained assistant during walking, SPS, loss of balance | NP | 1 | ||
Unspecified TSI | n-RCT | Sale et al. 2018 (B) (10) | 8 (6 M, 2F) | LOI: T1-L2 AIS A(3), B(4), C(1) Age: mean 43.25 years TSI: NR | 45 min × 5–6 days/week × 20 sessions | NO | Pre and Post each session: HR, BP Pre and Post training: 6MWT indoor/outdoor, BRPE, 10MWT, cadence, stride length, walking velocity, stance phase, swing phase, double support, pelvis tilt initial contact, ROM pelvis tilt, hip, knee and ankle flexion/extension ROM, TUG, VAS_p, VAS fatigue, Satisfaction Questionnaire | NP | 0 |
Total of Ekso studies | 275 (199 M, 76F) | LOI: Cervical (49), Thoracic (84), Lumbar (11), NR (115) AIS: A + B(164), C + D(95) Age: mean 42.55 years (individuals with SCI), mean 27.5 years (ABs) TSI: subacute (98), chronic (153), NR (8) | |||||||
Exoskeleton: ReWalk | |||||||||
Chronic | n-RCT | Asselin et al. 2015 (14) | 8 (7 M, 1F) | LOI: T2-T11 AIS A(7) B(1) Age: mean 46.2 years TSI: 5.9 years | 60–90 min × 1 session | NO | Single evaluation while sitting, standing and walking: VO2, HR After walking: BRPE(6–20) | NP | NR |
Khan et al. 2019 (14) | 12 (8 M, 4F) | LOI: C6-T10 AIS A(6), B(2), C(3), D(1) Age: mean 37.5 years TSI: mean 7.6 years | 12 weeks | NO | Each session: total steps number, steps without stopping, walking distance, walking speed Pre and Post each session: NRS_p Pre and Post training: UEMS, LEMS, MEP, sensory key-points ISNCSCI Pre, Mid and Post training: CoP limits of stability and sway speed Weekly: SCATS, McGill Pain Questionnaire Pain Rating Index Post training: 10MWT, 6MWT During 6MWT and wheelchair propulsion: PCI | Between 2 and 3 months: 10MWT, 6MWT, CoP limits of stability and sway speed | 3 | ||
Platz et al. 2016 (14) | 7 (5 M, 2F) | LOI: T-L AIS A(6), C(1) Age: mean 48.3 years TSI: mean 11.4 years | 1 h × 5 days/week × 4–5 weeks | NO | Number of session to achieve with physical help/verbal assistance/no assistance: sit to stand, stand to sit, standing balance 1 min with crutches, walk 10 mt straight, walk 10 m straight and in curve, ascend, turn around, descend 12 stairs, walk 500 m outdoor Pre and Post training: REPAS, LEMS, UEMS, ASIA sensory examination, SCIM, SF-12v2 | 1 month: SF-12v2 | 0 | ||
van Dijsseldonk et al. 2019 (13) | 20 (12 M, 8F) | LOI: T AIS A(19), B(1) Age: mean 37 years TSI: mean 8 years | 1.5 h × 3 days/week × 8 weeks | NO | Pre and Post training and every 2 weeks (2,4,6): evaluation of potential predictors (neurological lesion level, age, gender, age at injury onset, time since injury, physical activity level, level of anxiety and BMI) | NP | 4 | ||
Chun et al. 2020 (12) | 11 (10 M, 1F) | LOI: T2-T11 AIS A(9), B(2) Age: 18–65 years TSI: 1–15 years | 30–90 min × 3–4 days/week × 12–14 weeks | NO | Pre and Post training: Modified Lynch Gastrointestinal Survey, Bristol Stool Scale, SCI-QOL Bowel Management DIfficulties | NP | 1 | ||
Yang et al. 2015 (12) | 12 (10 M, 2F) | LOI: C8-T11 AIS A(9), B(2), C(1) Age: 16–75 years TSI: 1–20 years | 1–2 h x mean 55 sessions | NO | Best performance: correlation between level of assistance provided by trained assistant during walking versus 6MWT and 10MWT | NP | NR | ||
Benson et al. 2016 (11) | 10 (10 M) | LOI: C8-L1 AIS A(7), C(3) Age: mean 31.7 years TSI: 1–21 years | 2 h × 2 days/week × 10 weeks | NO | Pre and Post each session: HR, BP, AS, VAS_p, VAS fatigue Pre and Post Training: ISNCSCI, 10MWT, 6MWT, TUG, ADAPSS, ATD-PA | NP | 5 | ||
Fineberg et al. 2013 (11) | 9 (3 AB, 6 SCI) (7 M, 2F) | LOI: T1-T11 AIS A(5), B(1) Age: mean 44.83 years individuals with SCI), 41.67 years (ABs) TSI: 1.5–14 years | 1–2 h × 3 days/week × 5–6 months | AB walking wit ReWalk | Single evaluation after reaching the ability to walk 10 m: vGRF, walking velocity | NP | NR | ||
Guanziroli et al. 2019 (11) | 15 (11 M, 4F) | LOI: T4-L5 AIS A(15) Age: mean 39.3 years TSI: 6 months-15 years | 1 h × 3 days/week × 8 weeks (at least) | Comparison between two generations of ReWalk software | Single evaluation after training: 6MWT, 10MWT, STS-time | NP | 2 | ||
Zeilig et al. 2012 (11) | 6 (6 M) | LOI: T5-T12 AIS A(6) Age: mean 33.16 years TSI: 3–7 years | 50 min × 13.7 ± 5.8 sessions | NO | Pre and Post Training: VAS fatigue, VAS_p Each session: HR, BP, VAS fatigue, VAS_p Post Training (comparison between high vs low lesions): 10MWT, 6MWT, TUG, Satisfaction Questionnaire | NP | 2 | ||
Esquenazi et al. 2012 (10) | 12 (8 M, 4F) | LOI: T3-T12 AIS A(12) Age: mean 38.6 years TSI: 1–24 years | 75–90 min × 3 days/week × 8 weeks | NO | Pre and Post each session: HR, BP, AS, VAS_p, VAS fatigue Post Training: Satisfaction Questionnaire, 6MWT, 10MWT | 12–15 months (data not analyzed) | 0 | ||
Lonini et al. 2016 (9) | 11 (6 AB—5 SCI) (6 M, 5F) | LOI: T8-T10 AIS A(5) Age: mean 36.9 years TSI: 10 months-7 years | 1 h × 3 days/week × 6–12 weeks | Expert users: 6 ABs and 1 individual with SCI | Each session: steps frequency, steps number, EE, trunk angle Pre and Post training: 10MWT, Hip and Knee Flexion, Swing Time, Step Delay, Walking Speed | NP | 0 | ||
Manns et al. 2019 (6) | 11 (7 M, 4F) | LOI: NR AIS NR Age: mean 37.5 years TSI: mean 7.8 years | 60–90 min × 4 days/week × 12 weeks | NO | Pre and Post training: semi-structured interviews on "contributing, changing and learning" | 2 months: semi-structured interview on "contributing, changing and learning" | NR | ||
Talaty et al. 2013 (3) | 12 | LOI: C7-T12 AIS NR Age: NR TSI: Chronics | 60–90 min × 3 days/week × 24 sessions | NO | Single evaluation near training conclusion: comparison among fast vs medium vs slow velocity of flexion/extension ROM of trunk, hip, knee and ankle | NP | NR | ||
Total of ReWalk studies | 156 (107 M, 37F, 12 NR) | LOI: Cervical (7), Thoracic (107), Lumbar (3), NR (30) AIS: A + B(115), C + D(9), NR(23) Age: mean 39.18 years (individuals with SCI), mean 39.79 years (ABs) TSI: chronic (147) | |||||||
Exoskeleton: Indego | |||||||||
Chronic | n-RCT | Evans et al. 2015 (9) | 5 (4 M, 1F) | LOI: T6-T12 AIS A(5) Age: mean 42 years TSI: Chronics | 2 sessions | NO | Comparison between 1 session of 6MWT at comfortable speed vs 1 session of 6MWT at "fast but safe" speed: 6MWT, % Vo2 peak, Vo2 average,HR peak, Walking economy, MET | NP | NR |
Subacute + chronic | n-RCT | Juszczak et al. 2018 (10) | 45 (37 M, 8F) | LOI: T1-L2 AIS A(30), B(5), C(10) Age: mean 35 years TSI: Subacute/Chronics | 3–4 days/week × 8 weeks | NO | Before each session: NRS_p, NRS_sp Pre and Mid and Post training: donning/doffing time, NRS spasticity, MAS, indoor/outdoor BRPE (6–20), SWLS, Self reported Bowel and Bladder perception | NP | NR |
Unspecified TSI | n-RCT | Tefertiller et al. 2018 (12) | 32 (27 M, 5F) | LOI: T4-L2 AIS A(21), B(5), C(6) Age: mean 37 years TSI: NR | 3 days/week × 8 weeks | NO | Mid and Post training: indoor/outdoor 10MWT, 6MWT, TUG, Donn/doff time Single evaluation between Mid and Post training: 600MWT | NP | 0 |
Hartigan et al. 2015 (9) | 16 (13 M, 3F) | LOI: C5-L1 AIS A(11), B(3), C(2) Age: 18–51 years TSI: NR | 1.5 h × 5 sessions | NO | Last session: 10MWT, 6MWT, level of assistance provided by trained assistant during walking, donn/doff time | NP | NR | ||
Total of Indego studies | 98 (81 M, 17F) | LOI: Cervical (3), Thoracic (17), Lumbar (1), NR (77) AIS: A + B(80), C + D(18) Age: mean 38 years TSI: chronic (5), NR (93) | |||||||
Exoskeleton: HAL | |||||||||
Subacute | n-RCT | Yatsugi et al. 2018 (12) | 9 (6 M, 3F) | LOI: C2-L5 AIS incomplete Age: mean 53.6 years TSI: Subacute | 50 min x mean 5 sessions x mean 6 days | NO | Pre and Post training: 10MWT, Cadence, GARS-M, BI, WISCI II, Maximun lateral trunk swing angle during gait | NP | NR |
Kubota et al. 2019 (11) | 8 (4 M, 4F) | LOI: T2-T12 AIS D(8) Age: mean 60.9 years TSI: Subacute | 1 h × 2–3 days/week × 10 sessions (in association with CPT) | NO | Each session, Pre and Post-training: 10MWT, Cadence, Step lenght, WISCI II, LEMS, FIM | NP | 0 | ||
Total of HAL studies | 17 (10 M, 7F) | LOI: Thoracic (14), Lumbar (3) AIS: C + D(17) Age: mean 57.25 years TSI: subacute (17) | |||||||
Exoskeleton: Rex | |||||||||
Chronic | n-RCT | Birch et al. 2017 (9) | 20 (14 M, 6F) | LOI: C4-L5 AIS A and B (11), C and D (9) Age: mean 40.9 years TSI: 1–52 years | 3–4 h × 1 session | NO | Single evaluation: time to transfer into device, level of assistance provided by trained assistant to perform 2 excersises with upper extremities, TUG, Acceptability questionnaire | NP | NR |
EXO | Study | Skin lesion | Dizziness or Syncope | Swelling or Edema or Bruising | Soreness or Pain | Orthostatic Hypothension | Extreme fatigue or Sprain | Fall | Bone fracture | Muscle strain | Other |
---|---|---|---|---|---|---|---|---|---|---|---|
Ekso | Tsai et al. 2020 | ✓ | |||||||||
Chang et al. 2018 | ✓ | ||||||||||
Gagnon et al. 2018 (A)/(B) | ✓ | ✓ | ✓ | ||||||||
Ramanujam et al. 2018 (B) | |||||||||||
Baunsgaaard et al. 2018 (A) | ✓ | ✓ | ✓ | ||||||||
ReWalk | Khan et al. 2019 | ✓ | ✓ | ✓ | ✓ Trainer Adverse Event | ||||||
Platz et al. 2016 | ✓ | ✓ | ✓ | ||||||||
Yang et al. 2015 | ✓ | ||||||||||
Benson et al. 2016 | ✓ | ✓ | |||||||||
Esquenazi et al. 2012 | ✓ | ✓ | ✓ | ||||||||
Indego | Tefertiller et al. 2018 | ✓ | ✓ | ||||||||
Hartigan et al. 2015 | ✓ | ✓ | |||||||||
HAL | Kubota et al. 2019 | ✓ | ✓ |
Intervention
Comparison
Outcome measures
Study | Walking | Cardiorespiratory and metabolic responses | Spasticity | Balance | Quality of Life | Human Robot Interaction | ||
---|---|---|---|---|---|---|---|---|
Exoskeleton: Ekso | ||||||||
Subacute | n-RCT | Tsai et al. 2020 | ||||||
McIntosh et al. 2020 | Session 2, 13, 25: 6MWT ↗, 10MWT ↘ | Longitudinal evaluation: BP and HR: Sitting < Standing < After walking; BRPE (1–10) ↗ | Longitudinal evaluation: VAS_p ↘ | |||||
Chronic | RCT | Chang et al. 2018 | Post vs Pre training: stride length ↑; step length ↑; 6MWT ↑; cadence ↑; 10MWT ↓ | Post vs Pre training: TUG ↓ | ||||
n-RCT | Gagnon et al. 2018 (A) | Post vs Pre training: 10MWT ↓ | Longitudinal evaluation: level of assistance provided by trained assistant during walking ↘ | |||||
Escalona et al. 2018 | Single evaluation: HR, VO2, VCO2, RR and VE: Sitting < Standing < Walking; RER: Sitting > Standing < Walking; VT: Sitting < Walking; Single evaluation after walking: BRPE(1–10) not compared | |||||||
Sale et al. 2016 (A) | Post vs Pre training: velocity ↑; cadence ↑; 6MWT indoor/outdoor ↑; 10MWT ↓; step length ↑; step width ↑; stance time ↑, double support time (rigth ↑, left ↓) | Post vs Pre training: BRPE (1–10) ↓; VAS fatigue ↓ | Post vs Pre training: VAS_p ↓ | Post vs Pre training: TUG ↓ | Post vs Pre training: Satisfaction questionnaire ↑ | |||
Alamro et al. 2018 | Single evaluation: trunk medial–lateral/anterior–posterior acceleration Ekso-OG > trunk medial–lateral/anterior–posterior acceleration Lokomat; Trunk acceleration: no differences between Ekso-OG vs Ekso on treadmill | |||||||
Karelis et al. 2017 | ||||||||
Ramanujam et al. 2018 (A) | Single evaluation: walking velocity: SCI < ABs passive condition; stance time: SCI > ABs active condition; walking velocity: ABs with Ekso < ABs without Ekso; ROM: SCI < ABs active condition | |||||||
Gagnon et al. 2019 (B) | Post training: on line questionnaire not compared | |||||||
Ramanujam et al. 2018 (B) | Post vs Pre training individuals with SCI: walking speed ↑, stride time ↓, stance time ↓, double support ↓, step length ↑, step frequency ↑, stride length ↑ | |||||||
Kressler et al. 2014 (A) | Post vs Mid vs Pre training: 10MWT ↓, 2MWT ↑ | Post vs Mid vs Pre training: EE ↓ for 2/3 individuals, %VO2 peak ↓ for 2/3 individuals | Post vs Mid vs Pre training: SCATS ↓, ISCIBPD sleep interference ↓, NRS_p ↓ | |||||
Kressler et al. 2019 (B) | HR: Ekso < OG for 2/2 individuals; VO2, EE: Ekso < OG for 1/2 individuals | |||||||
Cahill et al. 2018 | Post training: semi structured interview not compared | |||||||
Subacute + chronic | n-RCT | Baunsgaard et al. 2018 (A) | Subacute: Post vs Pre training and FU vs Pre training: 10MWT ↓, WISCI II ↑ | Subacute: Session 1, 12, 24: HR: sitting < walking, BP nc; Longitudinal evaluation: BRPE(6–20) ↘ | Subacute: Post vs Pre training and FU vs Pre: TUG ↓, BBS ↑ | |||
Chronic: Post vs Pre training and FU vs Pre training: 10MWT ↓, WISCI II ↑ | Chronic: Session 1, 12, 24: HR sitting > standing, BP nc Longitudinal evaluation: BRPE(6–20) ↘ | Chronic: Post vs Pre training and FU vs Pre: TUG ↓, BBS ↑ | ||||||
Baunsgaard et al. 2018 (B) | FU vs Post vs Mid vs Pre training: ROM nc | Post vs Pre training: MAS ↓, Post vs Pre training and FU vs Pre training: ISCIBPDS ↓ | Post vs Pre training and FU vs Pre training: ISCIBDS (satisfaction item): chronic ↑, subacte nc | |||||
Stampacchia et al. 2016 | Post vs Pre single session: MAS ↓, NRS_sp ↓, PSFS ↓, NRS_p ↓ | Post single session: PGIC not compared, ad hoc questionnaire for subjective experience not compared | ||||||
Kozlowski et al. 2015 | Best performance: distance, 2MWT | METs: mid-time session > pre session; HR, BRPE(6–20): Sitting < Walking; HR, BRPE(6–20): Sitting < After Walking; BP variable | N of sessions to achieve: walk, stand/sit with minimal assistance: median of 8 sessions; "contact guard" for walking and stand/sit: median of 15 and 18 session; donn/doff assistance: not compared | |||||
Kolakowsky-Hayner et al. 2013 | Longitudinal evaluation: step length nc, distance ↗ | Longitudinal evaluation: SPS ↘ | Longitudinal evaluation: loss of balance ↘ and infrequent | Longitudinal evaluation: don/doff time ↘, level of assistance provided by trained assistant during walking ↘ | ||||
Unspecified TSI | n-RCT | Sale et al. 2018 (B) | Pre vs Post training: 6MWT indoor/outdoor ↑; 10MWT ↓, cadence ↑, stride length ↑, velocity ↑, hip and ankle ROM ↑, stance time ↓, double support time ↓ | Post vs Pre training: BRPE 1–10: outdoor ↓, indoor ↑; VAS fatigue ↓ | Post vs Pre training: VAS_p ↓ | Post vs Pre training: TUG ↓ | Post vs Pre training: Satisfaction questionnaire (safety and comfort items) ↑ | |
Exoskeleton: ReWalk | ||||||||
Chronic | n-RCT | Asselin et al. 2015 | Single evaluation: HR and VO2: Walking > Standing > Sitting; After walking: BRPE (6–20) not compared | |||||
Khan et al. 2019 | Longitudinal evaluation: steps without stopping ↗, distance ↗, walking speed ↗ FU vs Post training vs FU: 10MWT ↑, 6MWT ↓ | PCI walking with ReWalk > PCI wheelchair propulsion | Post vs Pre each sessions: NRS_p ↓ Weekly: McGill Pain Questionnaire Rating Pain Index nc, SCATS nc | Post vs Pre training: limits of stability ↑, sway speed in sitting ↓ FU vs Post training: limits of stability ↓, sway speed ↑ | ||||
Platz et al. 2016 | Post vs Pre training: REPAS ↓ | N of sessions to achieve: standing balance 1 min with crutches not compared | Post vs Pre training: SF-12v2 (single role-physical domain) ↑ FU vs Post training: SF-12v2 ↑; Post training: Satisfaction questionnaire not compared | N of sessions to achieve: sit to stand, stand to sit, walk 10 mt straight, walk 10 m straight and in curve, scend, turn around, and descend 12 steps, walk 500 m (outdoors): not compared | ||||
van Dijsseldonk et al. 2019 | Predictors of exoskeleton skill performance at Intermediate-skills-tests: lesion level, active lifestyle, age at injury, age at enrolment, BMI significantly correlate with EXO skill performance Post vs Pre training: no predictors significantly related to exoskeleton skill performance | |||||||
Chun et al. 2020 | ||||||||
Yang et al. 2015 | Best Performance: inverse relationship between level of assistance provided by trained assistant during walking and walking velocity for both 6MWT and 10MWT | |||||||
Benson et al. 2016 | Post vs Pre training: 10MWT ↓, 6MWT ↑ | Post vs Pre each session: HR ↑, BP ↑, VAS (fatigue) ↑ | Post vs Pre each session:: VAS_p ↑, AS ↓ | Post vs Pre training: TUG ↓ | Post vs Pre training: ADAPSS ↓, ATD-PA ↓ | |||
Fineberg et al. 2013 | Single evaluation: walking velocity and vGRF: SCI minimum assistanca < ABs minimum assistance | |||||||
Guanziroli et al. 2019 | Single evaluation: 10MWT: 2nd generation < 1st generation; 6MWT: 2nd generation > 1st generation | Single evaluation: STS: 2nd generation < 1st generation | ||||||
Zeilig et al. 2012 | Single evaluation Post training: 10MWT: low lesions < high lesions; 6MWT: low lesions > high lesions | Post vs Pre training: BP ↑, HR ↑, VAS (fatigue) ↑ | Post vs Pre training: VAS_p ↓ | Single evaluation Post training: TUG no difference between lesion level | Single evaluation Post training: Satisfaction questionnaire not compared | |||
Esquenazi et al. 2012 | Single evaluation Post training: 10MWT and 6MWT not compared | Post vs Pre each sessions: HR ↑, BP ↑, VAS fatigue nc | Pre vs Post across sessions: VAS_p ↓, AS ↓ | Single evaluation Post training: Satisfaction questionnaire not compared | ||||
Lonini et al. 2016 | Longitudinal evaluation: trunk angle ↘; Post vs Pre training: 10MWT ↓, Hip Flexion nc; Knee Flexion ↑, Swing Time ↓, Step Delay ↓ | Longitudinal evaluation: EE ↘ | ||||||
Manns et al. 2019 | Single evaluation Post training: semi structured interview spasticity ↓ for 4/11 individuals, pain ↓ for 2/11 individuals; FU: semi structured interview pain ↑ for 2/11 individuals | |||||||
Talaty et al. 2013 | Single evaluation: trunk flexion (initial swing), trunk extension (entire gait cycle), hip extension (entire gait cycle), pelvis extension (entire gait cycle), knee flexion (swing), ankle plantarflexion (early stance): fast group > medium/slow group knee extension (stance) nc across groups | |||||||
Exoskeleton: Indego | ||||||||
Chronic | n-RCT | Evans et al. 2015 | 6MWT: "Fast but safe" speed > comfortable speed | VO2 average and MET: "Fast but safe" speed > comfortable speed; %VO2 peak and HR peak: "Fast but safe" speed > comfortable speed; walking economy: "Fast but safe" speed < comfortable speed | ||||
Subacute + chronic | n-RCT | Juszczak et al. 2018 | Post vs Pre training: indoor BRPE(6–20) ↓, outdoor BRPE(6–20) nc | Post vs Pre training: MAS ↓, NRS_sp ↓ | Post vs Pre training: SWLS ↑ | Post vs Pre training: Donn time ↓, doff time ↓ | ||
Unspecified TSI | n-RCT | Tefertiller et al. 2018 | Post vs Mid training indoor/outdoor 10MWT ↓, 6MWT ↑; Single evaluation: 600MWT not compared | Post vs Mid training: TUG ↓ | Post vs Mid training: Donn/Doff time ↓ | |||
Hartigan et al. 2015 | Single evaluation: 10MWT, 6MWT: not compared | Single evaluation: Donn/Doff Time, level of external assistance provided by trained assistant during walking: not compared | ||||||
Exoskeleton: HAL | ||||||||
Subacute | n-RCT | Yatsugi et al. 2018 | Post vs Pre training: 10MWT ↓, cadence ↓, angle of trunk swing ↓, GARS-M score ↑, WISCI II ↑ | |||||
Kubota et al. 2019 | Post vs Pre training: 10MWT ↓, Step Lenght ↑, cadence ↑, WISCI II ↑ | |||||||
Exoskeleton: Rex | ||||||||
Chronic | n-RCT | Birch et al. 2017 | Single evaluation: TUG not compared | Single evaluation: Acceptability Questionaire: not compared | Single evaluation: Time to transfer into device and level of assistance provided by trained assistant to perform 2 excersises with upper extremities: not compared |
Study | Robot Data | Bowel functionality | Strength | Activities of Daily Living | Neurophysiology | Sensory function | Bladder functionality | Body composition and bone density | ||
---|---|---|---|---|---|---|---|---|---|---|
Exoskeleton: Ekso | ||||||||||
Subacute | n-RCT | Tsai et al. 2020 | Each session: up time, walk time and steps number: not compared | Post vs Pre training: LEMS ↑, UEMS ↑ | Post vs Pre training: FIM ↑ | |||||
McIntosh et al. 2020 | Longitudinal evaluation: up time ↗, walk time ↗, steps number ↗ | |||||||||
Chronic | RCT | Chang et al. 2018 | Post vs Pre training: LEMS ↑ | |||||||
n-RCT | Gagnon et al. 2018 (A) | Longitudinal evaluation: up time ↗; walk time ↗; steps number ↗ | ||||||||
Escalona et al. 2018 | ||||||||||
Sale et al. 2016 (A) | Post vs Pre training: satisfaction questionnaire (single bowel item) ↑ | |||||||||
Alamro et al. 2018 | Single evaluation: trunk muscle's activation: Ekso-OG > Lokomat | |||||||||
Karelis et al. 2017 | Post vs Pre training: BMI ↑; Body weight ↑; leg and appendicular lean body mass ↑; Total, appendicular and leg fat mass ↓; Cross-sectional area of calf Muscle ↑; Total, arm, trunk lean body mass ↑, Arm fat mass ↓, Trunk fat mass nc, Total bone mineral density ↓, Leg and tibia bone mineral density ↑, Cross-sectional area: Subcutaneous and intramuscular adipose tissue ↓ | |||||||||
Ramanujam et al. 2018 (A) | Single evaluation: EMG lower limbs: SCI < ABs | |||||||||
Gagnon et al. 2019 (B) | ||||||||||
Ramanujam et al. 2018 (B) | ||||||||||
Kressler et al. 2014 (A) | Post vs Mid vs Pre training: EMG nc | |||||||||
Kressler et al. 2019 (B) | ||||||||||
Cahill et al. 2018 | ||||||||||
Subacute + chronic | n-RCT | Baunsgaard et al. 2018 (A) | Subacute: Longitudinal evaluation: up time ↗, walk time ↗, steps ↗ | Subacute: Post vs Pre training and FU vs Pre training: LEMS ↑ | ||||||
Chronic: Longitudinal evaluation: up time ↗, walk time ↗, steps ↗ | Chronic: Post vs Pre training and FU vs Pre training: LEMS ↑ | |||||||||
Baunsgaard et al. 2018 (B) | FU vs Post vs Mid vs Pre training: ISCIBDS nc | Post vs Pre training and FU vs Pre training: SCIM III > | FU vs Post vs Mid vs Pre training: ISCIBDS nc | |||||||
Stampacchia et al. 2016 | ||||||||||
Kozlowski et al. 2015 | Best performance: walk time, up time, steps number | |||||||||
Kolakowsky-Hayner et al. 2013 | Longitudinal evaluation: up time ↗, walk time ↗ | |||||||||
Unspecified TSI | n-RCT | Sale et al. 2018 (B) | Post vs Pre training: Satisfaction questionnaire (single bowel item) ↑ | |||||||
Exoskeleton: ReWalk | ||||||||||
Chronic | n-RCT | Asselin et al. 2015 | ||||||||
Khan et al. 2019 | Londitudinal evaluation: total steps number ↗ | Post vs Pre training: UEMS ↑, LEMS ↑ | Post vs Pre training: MEP ↓ | Post vs Pre training: sensory key-points INSCSCI nc | ||||||
Platz et al. 2016 | Post vs Pre training: LEMS nc; UEMS nc | Post vs Pre training: SCIM nc | Post vs Pre training: sensory score INSCSCI nc | |||||||
van Dijsseldonk et al. 2019 | ||||||||||
Chun et al. 2020 | Post vs Pre training: Modified Lynch Gastrointestinal Survey: frequency of bowel evacuations nc, time spent on having a bowel movement nc, bowel accidents ↑, frequency of laxative and/or stool softener use ↑, overall satisfaction with bowel programs ↑; Bristol Stool Scale: stool consistency rated “ideal”↑; SCI-QOL ↓ | |||||||||
Yang et al. 2015 | ||||||||||
Benson et al. 2016 | ||||||||||
Fineberg et al. 2013 | ||||||||||
Guanziroli et al. 2019 | ||||||||||
Zeilig et al. 2012 | Single evaluation Post training: Satisfaction Questionnaire (single bowel item) nc | |||||||||
Esquenazi et al. 2012 | Single evaluation Post training: Satisfaction Questionnaire (bowel regulation) ↑ for 5/11 individuals | |||||||||
Lonini et al. 2016 | Longitudinal evaluation: step frequency ↗ and steps number ↗ (positive correlation with session) | |||||||||
Manns et al. 2019 | Single evaluation Post training: semi structured interview faster and more regular bowel movements for 3/11 individuals; FU: semi structured interview faster and more regular bowel movements for 1/11 individuals | |||||||||
Talaty et al. 2013 | ||||||||||
Exoskeleton: Indego | ||||||||||
Chronic | n-RCT | Evans et al. 2015 | ||||||||
Subacute + chronic | n-RCT | Juszczak et al. 2018 | Post vs Pre training: Self reported perception: 80% individuals nc, 20% individuals ↑ | Pre vs Post training: Self reported perception: 91% individuals nc, 9% individuals ↑ | ||||||
Unspecified TSI | n-RCT | Tefertiller et al. 2018 | ||||||||
Hartigan et al. 2015 | ||||||||||
Exoskeleton: HAL | ||||||||||
Subacute | n-RCT | Yatsugi et al. 2018 | Post vs Pre training: BI ↑ | |||||||
Kubota et al. 2019 | Post vs Pre training: LEMS↑ | Post vs Pre training: FIM ↑ | ||||||||
Exoskeleton: Rex | ||||||||||
Chronic | n-RCT | Birch et al. 2017 |