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

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Motor Learning Walking Program Behavioral
    Other Names: Task oriented walking training
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Motor Learning Walking Program
    Description: 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 Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Body weight supported treadmill training
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

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