A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Behavioral: Motor Learning Walking Program; Behavioral: Body Weight Supported Treadmill Training

• Registration Number: NCT00561405
• Lead Sponsor: McMaster University

Brief Summary

Stroke is a major cause of disability in Canadian adults. Following a stroke, many people have difficulty walking in their home and in the community. The purpose of this study is to compare the effect of two different approaches to walking retraining in people who have had a stroke.

Individuals living in the community who have had recently had a stroke will be asked to participate in this study. Participants will be randomly assigned to one of two five week walking training programs. In one program, individuals will re-learn to walk in a variety of real-life situations. Practice sessions will encourage active problem solving by the participants. The other program will have participants practice walking on a treadmill while some of their body weight is supported by a special harness system. Participants will also be assisted by a physiotherapist to walk in a more normal manner.

Participants' will be assessed at the beginning of the study, after the 5 week training program and again, eight weeks later. The research assistant will assess their ability to walk, their confidence level and the average daily walking activity.

Primary Hypothesis: Individuals assigned to the Motor Learning Walking Program will improve their walking ability from baseline to follow up assessment significantly more than individuals assigned to the Treadmill Training Program.

The results of this study will help physiotherapists plan effective treatment programs for individuals with walking difficulties following stroke. It will also give researchers direction for future studies in the areas of walking retraining and motor skill development post-stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Stroke onset within previous 12 months
• Age 40 or older
• Able to follow 2 step verbal command (English),
• Able to walk 10 metres without human assistance (may use walking aid)
• Independent community ambulatory prior to stroke
• Community dwelling
• Approval from physician for participation in study

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Exclusion Criteria

• Walking speed greater than 1.0 m/s without walking aid
• Within normal limits on Modified Mini Mental Status test (age and education adjusted)
• Documented global aphasia
• Legal blindness
• Unable to exercise due to the any of the following conditions
• A recent significant change in resting ECG suggesting ischemia
• Recent Myocardial infarction (within 3 months) or other acute cardiac event
• Unstable angina
• Severe SOB at rest or with activities of daily living
• Uncontrolled cardiac arrhythmias causing symptoms
• Severe symptomatic aortic stenosis
• Uncontrolled symptomatic heart failure
• Acute pulmonary embolus or pulmonary infarction
• Acute myocarditis or pericarditis
• Suspected or known dissecting aneurysm
• Acute systemic infection, accompanied by fever, body ache or swollen lymph glands
• Uncontrolled hypertension (systolic > 200 mmHg, diastolic > 110 mmHg )
• Severe peripheral vascular disease with sustained claudication (resulting in limited walking tolerance)
• Severe lower extremity orthopedic problems with severe pain on weight bearing
• Lower extremity amputation that requires prosthesis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor Learning Walking Program	Motor Learning Walking Program	Motor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner.
Body weight supported treadmill training	Body Weight Supported Treadmill Training	Body Weight Supported Treadmill Training. Participants walk on a treadmill while partially supported with an overhead harness system. Mass repetition of the normal gait cycle is encouraged through the support of the harness, the movement of the treadmill, and the assistance of one or two trainers to position limbs and trunk.

Primary Outcome Measures

Name	Time	Method
Self selected over ground gait speed - 5 metre walk test	8 week follow up

Secondary Outcome Measures

Name	Time	Method
Number of trainers required per treatment session	Documented at every treatment session for both experimental and active comparison interventions.
Six Minute Walk Test	Post Intervention and 8 week follow up
Dynamic Balance - Functional Balance Test	Baseline, Post-intervention and 8 week Follow-up	Over a 9 m track - participants are required to perform 5 balance and walking related tasks. Participants are required to 1) rise from a chair, walk 3 m, 2) step up and down an 8 inch step, walk 3 m, 3) bend down to pick up and return a 2.5 kilo weight off floor, walk 3 m to marked spot on the floor, 4) turn 180 degrees and walk 9 m back to the chair, 5. sit back down in the chair.; Each task is scored on a 4 point scale (total score of out 20) Participants are timed on how long it takes them to perform the entire circuit.
Patient Specific Functional Scale	Baseline, Post-intervention, Follow-up (8weeks)	In this measure, participants are asked to identify 3 walking related functional activities that they currently have some difficulty performing and would like to improve with treatment. For each activity, the participant rates their current ability to perform the task on a numeric rating scale of 0 to 10.; At Post-intervention and Follow-up, participants re-rate their current ability on the same activites (without seeing their previous score).
Self selected over ground gait speed - 5 metre walk test	Post Intervention
Life Space Questionnaire	Baseline, Post-intervention, and at 8 week follow up	Self-report measure of mobility partipation.
Balance related Self Efficacy - Activities-specific Balance Confidence Scale	Post intervention and 8 week follow up
Average Daily Step Count - StepWatch 3 Step Activity Monitor	Post Intervention and 8 Week Follow up
Adverse event - Falls (yes or no)	Follow - up - 8 weeks after post-intervention assessment	Participant asked to report whether or not they had a fall since Post Intervention assessment. Details of the fall will be provided.; Based on participant recall - no other tools for falls recording will be used (ie. will not be using falls diary)
Rating of Walking functional level - Modified Functional Walking Categories	Baseline, Post-intervention, Follow-up (8 weeks)
Adverse event - Self-report of a fall(s) since baseline assessment	Post Intervention Assessment	Participants will be asked whether or not they have had a fall since baseline assessment. Details of the fall(s) will be recorded. Fall report based on participant recall - no other tools (e.g. diary) will be used.
Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death	Post-intervention, Follow up (8 weeks)	Serious adverse events will be based on participant or caregiver report, and confirmed with primary care physician as appropriate.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada