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

September 23, 2011 updated by: Vince DePaul, McMaster University

A Motor Learning Based Walking Program Versus Body Weight Supported Treadmill Training in Community Dwelling Adults Within One Year of Stroke Onset: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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. Sessions 45 minutes, 3x per week over 5 weeks for a total of 15 sessions
Other Names:
  • Task oriented walking training
Active Comparator: 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.
Behavioral: Body Weight Supported Treadmill Training
Participants practice walking on a treadmill while supported with an overhead harness system. Up to 40% body weight support. Target Treadmill speed 2.0 mph. 1 or 2 Trainers (at least one Physical Therapist plus another Physical Therapist or Physiotherapy Assistant) will help guide participants leg, foot and trunk during treatment. Aim is to practice high numbers of repetition of the normal gait cycle on treadmill. Duration of sessions - 20 minutes of treadmill training within a 45 minute session ( 4 sets of 5 minutes of training with 5 minute rests). 3 sessions per week for 5 weeks. Total of 15 sessions.
Other Names:
  • Treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self selected over ground gait speed - 5 metre walk test
Time Frame: 8 week follow up
8 week follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk Test
Time Frame: Post Intervention and 8 week follow up
Post Intervention and 8 week follow up
Self selected over ground gait speed - 5 metre walk test
Time Frame: Post Intervention
Post Intervention
Balance related Self Efficacy - Activities-specific Balance Confidence Scale
Time Frame: Post intervention and 8 week follow up
Post intervention and 8 week follow up
Average Daily Step Count - StepWatch 3 Step Activity Monitor
Time Frame: Post Intervention and 8 Week Follow up
Post Intervention and 8 Week Follow up
Dynamic Balance - Functional Balance Test
Time Frame: 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.
Baseline, Post-intervention and 8 week Follow-up
Life Space Questionnaire
Time Frame: Baseline, Post-intervention, and at 8 week follow up
Self-report measure of mobility partipation.
Baseline, Post-intervention, and at 8 week follow up
Number of trainers required per treatment session
Time Frame: Documented at every treatment session for both experimental and active comparison interventions.
Documented at every treatment session for both experimental and active comparison interventions.
Patient Specific Functional Scale
Time Frame: 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).
Baseline, Post-intervention, Follow-up (8weeks)
Rating of Walking functional level - Modified Functional Walking Categories
Time Frame: Baseline, Post-intervention, Follow-up (8 weeks)
Baseline, Post-intervention, Follow-up (8 weeks)
Adverse event - Self-report of a fall(s) since baseline assessment
Time Frame: 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.
Post Intervention Assessment
Adverse event - Falls (yes or no)
Time Frame: 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)
Follow - up - 8 weeks after post-intervention assessment
Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death
Time Frame: 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.
Post-intervention, Follow up (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Ontario Ministry of Health and Long Term Care

Investigators

  • Principal Investigator: Vincent G DePaul, PhD (c), McMaster University, Hamilton, ON, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 23, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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