A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke
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
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started Dec 2006
Longer than P75 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 26, 2011
September 1, 2011
4.1 years
November 20, 2007
September 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self selected over ground gait speed - 5 metre walk test
8 week follow up
Secondary Outcomes (12)
Six Minute Walk Test
Post Intervention and 8 week follow up
Self selected over ground gait speed - 5 metre walk test
Post Intervention
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
Dynamic Balance - Functional Balance Test
Baseline, Post-intervention and 8 week Follow-up
- +7 more secondary outcomes
Study Arms (2)
Motor Learning Walking Program
EXPERIMENTALMotor 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
ACTIVE COMPARATORBody 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Ontario Ministry of Health and Long Term Carecollaborator
Study Sites (1)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Related Publications (1)
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.
PMID: 22018267DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent G DePaul, PhD (c)
McMaster University, Hamilton, ON, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist (PT), PhD (candidate)
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
December 1, 2006
Primary Completion
January 1, 2011
Study Completion
June 1, 2011
Last Updated
September 26, 2011
Record last verified: 2011-09