Administrative information
Title {1} | Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT) |
Trial registration {2a and 2b}. | NCT03009773. Registered on January 4, 2017. https://clinicaltrials.gov/ct2/show/NCT03009773 Institutional review board: CPP Nord-Ouest II, Amiens, France: reference: RCB 2016-A00342-49, dated May 13, 2016. |
Protocol version {3} | V5.0 dated December 3, 2021. |
Funding {4} | The study is funded by the French state through the Hospital-Based Clinical Research Program. |
Author details {5a} | Sophie Tasseel-Ponche1,2, Martine Roussel2,3, Monica Toba2, Thibaud Sader1, Vincent Barbier1, Arnaud Delafontaine1, Jonathan Meynier4, Carl Picard4, Jean-Marc Constans5, Alexis Schnitzler6,7, Olivier Godefroy2,3, Alain Pierre Yelnik6,8 1 Department of Physical Medicine and Rehabilitation, Amiens University Hospital, Amiens, France 2 Laboratory of Functional Neurosciences, UR UPJV 4559, Jules Verne University of Picardie, Amiens, France 3 Department of Neurology, Amiens University Hospital, Amiens, France 4 Clinical Research and Innovation Directorate, Amiens University Hospital, Amiens, France 5 Department of Radiology, Amiens, University Hospital, Amiens, France 6 PRM Department, Hôpital Lariboisière-F.Widal AP-HP, Paris, France 7 INSERM U1153 - CRESS EpiAgeing, Paris University, Hôtel-Dieu, Paris, France 8 UMR 9010, Paris University, Centre Borelli, Paris, France |
Name and contact information for the trial sponsor {5b} | The study is funded by the French state through the Hospital-Based Clinical Research Program. The study sponsor is Amiens University Medical Center (contact address: Direction de la Recherche Clinique et de l'Innovation, CHU Amiens Picardie, 1 rond-point du Pr C. Cabrol, Cedex 1, Amiens, France). |
Role of sponsor {5c} | The study’s funder and sponsor had no role in the study design or the collection, analysis, interpretation and presentation of the study data. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
The control group: ST GR program (Table 1)
Progression | Five types of 5-min gait exercises (30 min per session, 3 times a week on D1, D2, and D3) | Level of motor difficulty |
---|---|---|
Week 1 | - Walking forwards - Walking sideways on the healthy side - Walking sideways on the hemiparetic side - Walking backwards - Walking and crossing flat obstacles | 1/ Comfortable walking 2/ Walking with weights (100–250 g) 3/ Walking along a line |
If an exercise is impossible, the patient will repeat the last successfully completed exercise or session (so as not to waste the 30 min of GR). | ||
Week 2 | - Walking forwards - Walking sideways on the healthy side - Walking sideways on the hemiparetic side - Walking backwards - Walking and crossing obstacles | 4/ Comfortable walking with weights (100–250 g) 5/ Comfortable walking with weights (250–500 g) 6/ Comfortable walking and crossing obstacles <5 cm in height |
If an exercise is impossible, the patient will repeat the last successfully completed exercise or session (so as not to waste the 30 min of GR). | ||
Week 3 | - Walking forwards - Walking sideways on the healthy side - Walking sideways on the hemiparetic side - Walking backwards - Walking on a foam carpet | 7/ Fast walking 8/ Fast walking with weights (100–250 g) 9/ Fast walking on a foam carpet |
If an exercise is impossible, the patient will repeat the last successfully completed exercise or session (so as not to waste the 30 min of GR). | ||
Week 4 | - Walking forwards - Walking sideways on the healthy side - Walking sideways on the hemiparetic side - Walking backwards - Walking on a foam carpet | 10/ Fast walking with weights (100–250 g) 11/ Fast walking with weights (250–500 g) 12/ Fast walking and crossing obstacles <10 cm in height |
If an exercise is impossible, the patient will repeat the last successfully completed exercise or session (so as not to waste the 30 min of GR). |
The experimental group: DT GR program (Table 2)
Progression | Five types of 5-min gait exercise (30 min per session, 3 times a week (on days (D)1, D2, and D3) | Level of motor difficulty | Level of cognitive difficulty |
---|---|---|---|
Week 1 | - Walking during an executive function task: go/no-go letters (D1: letter “A,” D2: letter “B,” D3: letter “Z”) - Walking during a memory task: minus -2 span - Walking while holding an object in the healthy hand: a half-full glass of water - Walking during a semantic fluency task (D1 animals, D2 fruits, D3 supermarket articles) - Walking during while looking for targets in the space ahead (D1 objects, D2 images, D3 words) | 1/ Comfortable walking 2/ Walking with weights (100–250 g) 3/ Walking along a line | 1/ A quiet environment 2/ Music selected by the patient 3/ News radio (France Info) |
If an exercise is impossible, replace it with a calculation (plus 2) and the following starting numbers: 0, 1, 14, 43, 128 (5 × 1 min). If this is impossible, count backwards or forwards, depending on the patient's abilities. | |||
Week 2 | - Walking during an executive function task: go/no-go Letters (D1: letter “A,” D2: letter “B,” D3: letter “Z”) - Walking during a memory task: minus −1 span - Walking while holding an object in the healthy hand: a 75%-full glass of water - Walking during a semantic fluency task (D1 kinds of bird, D2 towns, D3 colors) - Walking during while looking for targets on the healthy side (D1 objects, D2 images, D3 words) | 4/ Comfortable walking with weights (100–250 g) 5/ Comfortable walking with weights (250–500 g) 6/ Comfortable walking and crossing obstacles <5 cm in height | 1/ A quiet environment 2/ Music selected by the patient 3/ News radio (France Info) |
If an exercise is impossible, replace it with a calculation (plus 3) and the following starting numbers: 0, 1, 14, 43, 128 (5 × 1 min). If this is impossible, count backwards or forwards, depending on the patient's abilities. | |||
Week 3 | - Walking during an executive function task: go/no-go numbers - Walking during a memory task: minus −2 alphabetic span - Walking while holding an object in the paretic hand: a half-full glass of water - Walking during an alternating semantic fluency task (D1 animals/fruits, D2 fruits/vegetables, D3 fruits/supermarket articles) - Walking while looking for targets on the paretic side (D1 objects, D2 images, D3 words) | 7/ Fast walking 8/ Fast walking with weights (100–250 g) 9/ Fast walking on a foam carpet | 1/ A quiet environment 2/ Music selected by the patient 3/ News radio (France Info) |
If an exercise is impossible, replace it with a calculation (minus 2) and the following starting numbers: 0, 1, 14, 43, 128 (5 × 1 min). If this is impossible, count backwards or forwards, depending on the patient's abilities. | |||
Week 4 | - Walking during an executive function task: go/no-go numbers - Walking during a memory task: minus −1 alphabetic span - Walking while holding an object in the paretic hand: a 75%-full glass of water - Walking during an alternating semantic fluency task (D1 kinds of fish/bird, D2 fruits/towns, D3 colors/furniture - Walking while looking for targets in the space behind (D1 objects, D2 images, D3 words) | 10/ Fast walking with weights (100–250 g) 11/ Fast walking with weights (250–500 g) 12/ Fast walking and crossing obstacles <10 cm in height | 1/ Quiet environment 2/ Music selected by patient 3/ News radio (France Info) |
If an exercise is impossible, replace it with a calculation (minus 3) and the following starting numbers: 0, 1, 14, 43, 128 (5 × 1 min). If this is impossible, count backwards or forwards, depending on the patient's abilities. |
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Clinical assessments at baseline (Table 3)
Recruitment | Inclusion M0 | Follow-up visit at M1 | Follow-up visit at M2 | Follow-up visit at M6 | |
---|---|---|---|---|---|
Investigator | |||||
Patient information | ✓ | ||||
Informed consent | ✓ | ||||
Demographic dataa | ✓ | ||||
Randomization | ✓ | ||||
Gait classification | ✓ | ||||
Strokeb | ✓ | ||||
NIHSS | ✓ | ✓ | ✓ | ✓ | |
Fugl-Meyer (lower limb)c | ✓ | ✓ | ✓ | ✓ | |
FIM | ✓ | ✓ | ✓ | ✓ | |
mRS-SI | ✓ | ✓ | ✓ | ✓ | |
QoL-VAS | ✓ | ✓ | ✓ | ✓ | |
AEs and SAEs | ✓ | ✓ | ✓ | ||
Therapists | |||||
ST 10 MWT | ✓ | ✓ | ✓ | ✓ | |
DT 10 MWT | ✓ | ✓ | ✓ | ✓ | |
ST TUG | ✓ | ✓ | ✓ | ✓ | |
DT TUG | ✓ | ✓ | ✓ | ✓ | |
Neuropsychologist | |||||
Neuropsychological batteryd | ✓ | ✓ | ✓ | ✓ | |
Radiologist | |||||
MRI | ✓ 280 patients in 12 centers (4 and 6 months after stroke) | ||||
fMRI and fMRS | ✓ 20 patients at the Amiens center (4 and 6 months after stroke) |
- Detecting global cognitive impairments: | |
• Mini-Mental State Examination [57] | |
- Detection of the main cognitive disorders: | |
• Phasic: center using scale except Battery for the Evaluation of Lexical Disorders [58] | |
• Praxis: Florence Mayeux’s symbolic praxis test [59] | |
• Memory: short-term memory with an immediate verbal serial number recall (Baddeley task) and long-term verbal and visual memory | |
• Spatial neglect: Albert’s test | |
- Description of executive functions: | |
• Flexibility of attention: Trail-Making Test parts A and B [48] | |
• Dual task performance: Baddeley task [60] | |
• Inhibition: Stroop tasks [48] | |
• Verbal fluency: literal fluency (“P” at M0, “V” at M1, “R” at M2 and “B” at M6) | |
• Processing speed index (PSI): third edition of the Wechsler adult intelligence scale (WAIS-III) | |
• Dysexecutive behavior syndrome (BDSI) [49] | |
- Detection of mood disorders: | |
• Depression assessment on the Montgomery-Asberg Depression Rating Scale (MADRS) [90] | |
• Anxiety assessment on the Goldberg scale [91] |
mRS-SI 5 | Bedridden: ‘Is the person bedridden?’ | |
- The patient is unable to walk even with another person’s assistance. | Yes □ No □ | |
- If placed in a wheelchair, unable to self-propel effectively. | ||
- May frequently be incontinent. | ||
- Requires nearly constant care (provided by either a trained or untrained caregiver): someone needs to be available nearly at all times. | ||
mRS-SI 4 | Assistance to walk: ‘Is another person’s assistance essential for walking?’ | |
- Requiring another person’s assistance means needing another person to be always present when walking, including indoors around house or ward, to provide physical help, verbal instruction, or supervision. | Yes □ No □ | |
- Patients who use physical aids to walk (stick, walker) but do not require another person’s help, are NOT rated as requiring assistance to walk. | ||
- For patients who use wheelchairs, patient needs another person’s assistance to transfer into and out of chair, but can self-propel effectively without assistance. | ||
mRS-SI 3 | Assistance to look after own affairs1: “Could the patient live alone for 1 week if he/she absolutely had to?” | |
3.1 | - Is assistance essential for preparing a simple meal? | Yes □ No □ |
3.2 | - Is assistance essential for basic household chores? | Yes □ No □ |
3.3 | - Is assistance essential for looking after household expenses and to manage day-today purchases? | Yes □ No □ |
3.4 | - Is assistance essential for local travel and transportation? | Yes □ No □ |
3.5 | - Is assistance essential for taking medication in correct dosages at correct time (includes preparation in advance, recall and supervision)? | Yes □ No □ |
3.6 | - Telephone use: Is assistance essential for look up and dial numbers? | Yes □ No □ |
mRS-SI 2 | Limitations in participation in usual duties and activities: “has there been a change in the person’s ability to work or look after others or participate to leisure activities as compared with prestroke status? This supposes that it is due to the new stroke itself.” | |
2.1 | - Has the stroke substantially reduced the person’s ability to work or, for a student, to study? (Change from full-time to part-time, change in level of responsibility, or unable to work at all). | Yes □ No □ |
2.2 | - Has the new stroke substantially reduced the person’s ability to look after family at home? | Yes □ No □ |
2.3 | - Has the new stroke reduced the person’s regular free-time activities2? | Yes □ No □ |
2.4 | - Is this reduction in activity related to a physical/medical problem other than the stroke? If yes which one? Details: | Yes □ No □ |
mRS-SI 1 | Persisting symptoms as a result of the stroke: “Does the patient have any symptoms resulting from the new stroke?” “Does the person have:” | |
- Difficulty reading or writing? | Yes □ No □ | |
- Difficulty speaking or finding the right word? | Yes □ No □ | |
- Problems with balance or coordination? | Yes □ No □ | |
- Visual problems as a result of the stroke? | Yes □ No □ | |
- Numbness (face, arms, legs, hands, feet)? | Yes □ No □ | |
- Weakness or loss of movement (face, arms, legs, hands, feet)? | Yes □ No □ | |
- Difficulty with swallowing | Yes □ No □ | |
- Sleeping difficulty? | Yes □ No □ | |
- Headaches as a result of stroke? | Yes □ No □ | |
- Otherwise unexplained reduction of activities, anxiety, depressive mood, or sadness repetitive concerns (especially about his/her health or situation)? | Yes □ No □ | |
- Loss of consciousness? | Yes □ No □ | |
- Other symptoms? Details: | Yes □ No □ |