Background
Varied Overground Walking-task Training
Body Weight Supported Treadmill Training
Methods/design
Design Outline
Ethics
Participants
Randomization
Experimental Intervention: Motor Learning Walking Program (MLWP)
Content of the MLWP
Core Tasks
Increasing Complexity of Walking Task Practice
Comparison Intervention: Body Weight Supported Treadmill Training (BWSTT)
Learning Variable/Principle | Motor Learning Walking Program | Body Weight Supported Treadmill Training |
---|---|---|
Amount of Practice/Intensity
| Up to 40 minutes of walking activity per session 15 sessions over 5 weeks | Up to 30 minutes treadmill walking per session 15 sessions over 5 weeks |
Specificity Of Practice
| Reflects task and environmental demands of community walking | High repetitions of near normal gait cycle on treadmill |
Variable Practice
| Variable practice of different overground walking tasks | Single task practice - walking on treadmill |
Practice Order
| Random or serial order, moving through different tasks returning to each task at least once. | Blocked or mass practice of single task of walking on treadmill |
Augmented
Feedback
| Encourage self-evaluation through delayed, intermittent and summary feedback KP and results KR provided | Continuous, immediate visual (mirror) and/or verbal feedback. Focus on KP, specifically related to posture and gait pattern |
Instructions
| Instructions provided related to the goals of the task. Emphasis on problem solving, discovery of alternate ways to complete walking tasks. | Instructions regarding performance of near normal gait pattern |
Physical Guidance
| Physical guidance provided for safety, or initial completion of basic task early in learning. Emphasis on allowing participants to make and attempt to correct errors. | Frequent guidance of one to three trainers at pelvis, hemi and non-hemi-limb to guide position and timing Up to 40% body weight support provided through harness - weaned according to performance Handle use discouraged Errors prevented or minimized |
Training Personnel
| Physiotherapist × 1 | Physiotherapist × 1 plus 1 to 2 other physiotherapists or physiotherapy assistants |
Training Setting
| In hospital physiotherapy department, other parts of hospital and outdoors | In hospital outpatient department on treadmill |
Training Speed
| Practice of comfortable and fast walking | Will train at, or above target speed 2.0 mph (0.89 m/s) as soon as participant is able |
Use Of Walking Aid/Orthoses
| Practice with and without orthoses and walking aid | Practice without walking aid, may use orthoses if necessary |
Outcomes
ICF
|
Domain
|
Instrument
|
Screening/Baseline
|
Post -Intervention
|
Follow-up
|
---|---|---|---|---|---|
Personal and Environmental Factors | Stroke details | Interview, health record review | X | ||
Comorbidities | X | ||||
Living situation | X | ||||
Gait aid | X | X | X | ||
Physiotherapy | X | X | X | ||
Fall history | X | X | X | ||
Adverse events | X | X | X | ||
Body Structures/Function | Motor recovery | Chedoke-McMaster Stroke Assessment | X | ||
Cognition | Mini Mental Status Examination | X | |||
Depression | Geriatric Depression Scale Short form-15 | X | |||
Activity | Walking speed | 5 metre walk test | X | X | X |
Walking endurance | Six Minute Walk Test | X | X | X | |
Dynamic balance | Functional Balance Test | X | X | X | |
Balance self-efficacy | Activities-specific Balance Confidence Scale | X | X | X | |
Goal attainment | Patient Specific Functional Scale | X | X | X | |
Participation | Walking independence | Modified Functional Ambulation Categories | X | X | X |
Daily walking activity | Step Watch 3.0 step activity monitor | X | X | X | |
Mobility participation | Life Space Questionnaire | X | X | X | |
Health related quality of life | Stroke Impact Scale 3.0 | X | X | X |
Sample size
Statistical Analysis
Primary Analysis
Secondary Analysis
Sensitivity Analyses
Objective/Variable
|
Hypothesis
|
Outcome measure (type)
[continuous (c), binary (b)]
|
Method of Analysis
|
---|---|---|---|
1) Primary
| |||
Walking speed at post-intervention (T2) | MLWP > BWSTT | Comfortable gait speed (c) | ANCOVA |
2)
Secondary (T2, T3)
| |||
Secondary outcomes | |||
a) Fast walking speed | MLWP > BWSTT | Fast Gait Speed (c) | ANCOVA |
b) Walking endurance | MLWP > BWSTT | Six minute walk test(c) | ANCOVA |
c) Balance and walking related self-efficacy | MLWP > BWSTT | Activities-specific Balance Confidence Scale (c) | ANCOVA |
d) Dynamic balance | MLWP > BWSTT | Functional Balance Test(c) | ANCOVA |
e) Mobility participation | MLWP > BWSTT | Life Space Questionnaire (c) | ANCOVA |
f) Health-related quality of life | MLWP > BWSTT | Stroke Impact Scale 3.0 (c) | ANCOVA |
g) Goal attainment | MLWP > BWSTT | Patient Specific Function Scale(c) | ANCOVA |
h) Walking participation | MLWP < BWSTT | Mean daily step activity | ANCOVA |
i) Training staff requirement | MLWP < BWSTT | Total number of trainers/number of training sessions (c) | T-test |
j) Meaningful change in gait speed of ≥ 0.14 m/s | MLWP > BWSTT | Comfortable gait speed change score T2-T1 ≥ 0.14 m/s)(b) | Chi-square test |
Adverse events (count) | |||
a) Falls during session | Therapist report (b) | Chi-square test | |
b) Injury during session | Therapist report (b) | Chi-square test | |
c) Falls between session | Patient report (b) | Chi-square test | |
d) Myocardial Infarction | Patient report/health record (b) | Chi-square test | |
e) New stroke | Patient report/health record (b) | Chi-square test | |
f) Hospitalization | Patient report/health record (b) | Chi-square test | |
g) Death (all causes) | Health record/Physician (b) | Chi-square test | |
3)
Sensitivity Analysis
| |||
a) All outcomes analysed simultaneously to account for correlation among them | Primary and secondary outcomes | MANOVA | |
b) Serial correlation of all outcomes at baseline, T2, T3 | Primary and secondary outcomes | GEE | |
c) Completers (≥ 12 sessions) | MLWP > BWSTT | Comfortable Gait speed | ANCOVA |