search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Motor Learning Walking Program
Body Weight Supported Treadmill Training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Walking, Motor learning, Skill acquisition

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor Learning Walking Program

Body weight supported treadmill training

Arm 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. 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.

Outcomes

Primary Outcome Measures

Self selected over ground gait speed - 5 metre walk test

Secondary Outcome Measures

Six Minute Walk Test
Self selected over ground gait speed - 5 metre walk test
Balance related Self Efficacy - Activities-specific Balance Confidence Scale
Average Daily Step Count - StepWatch 3 Step Activity Monitor
Dynamic Balance - Functional Balance Test
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.
Life Space Questionnaire
Self-report measure of mobility partipation.
Number of trainers required per treatment session
Patient Specific Functional Scale
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).
Rating of Walking functional level - Modified Functional Walking Categories
Adverse event - Self-report of a fall(s) since baseline 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.
Adverse event - Falls (yes or no)
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)
Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death
Serious adverse events will be based on participant or caregiver report, and confirmed with primary care physician as appropriate.

Full Information

First Posted
November 20, 2007
Last Updated
September 23, 2011
Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care
search

1. Study Identification

Unique Protocol Identification Number
NCT00561405
Brief Title
A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Walking, Motor learning, Skill acquisition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Learning Walking Program
Arm Type
Experimental
Arm 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.
Arm Title
Body weight supported treadmill training
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Motor Learning Walking Program
Other Intervention Name(s)
Task oriented walking training
Intervention 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. Sessions 45 minutes, 3x per week over 5 weeks for a total of 15 sessions
Intervention Type
Behavioral
Intervention Name(s)
Body Weight Supported Treadmill Training
Other Intervention Name(s)
Treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self selected over ground gait speed - 5 metre walk test
Time Frame
8 week follow up
Secondary Outcome Measure Information:
Title
Six Minute Walk Test
Time Frame
Post Intervention and 8 week follow up
Title
Self selected over ground gait speed - 5 metre walk test
Time Frame
Post Intervention
Title
Balance related Self Efficacy - Activities-specific Balance Confidence Scale
Time Frame
Post intervention and 8 week follow up
Title
Average Daily Step Count - StepWatch 3 Step Activity Monitor
Time Frame
Post Intervention and 8 Week Follow up
Title
Dynamic Balance - Functional Balance Test
Description
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.
Time Frame
Baseline, Post-intervention and 8 week Follow-up
Title
Life Space Questionnaire
Description
Self-report measure of mobility partipation.
Time Frame
Baseline, Post-intervention, and at 8 week follow up
Title
Number of trainers required per treatment session
Time Frame
Documented at every treatment session for both experimental and active comparison interventions.
Title
Patient Specific Functional Scale
Description
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).
Time Frame
Baseline, Post-intervention, Follow-up (8weeks)
Title
Rating of Walking functional level - Modified Functional Walking Categories
Time Frame
Baseline, Post-intervention, Follow-up (8 weeks)
Title
Adverse event - Self-report of a fall(s) since baseline assessment
Description
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.
Time Frame
Post Intervention Assessment
Title
Adverse event - Falls (yes or no)
Description
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)
Time Frame
Follow - up - 8 weeks after post-intervention assessment
Title
Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death
Description
Serious adverse events will be based on participant or caregiver report, and confirmed with primary care physician as appropriate.
Time Frame
Post-intervention, Follow up (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent G DePaul, PhD (c)
Organizational Affiliation
McMaster University, Hamilton, ON, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22018267
Citation
DePaul VG, Wishart LR, Richardson J, Lee TD, Thabane L. Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol. BMC Neurol. 2011 Oct 21;11:129. doi: 10.1186/1471-2377-11-129.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs