Clinical trial NCT00561405: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
Walking
Motor learning
Skill acquisition
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2007-11-21
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self selected over ground gait speed - 5 metre walk test
timeFrame: 8 week follow up
Secondary outcomes:
measure: Six Minute Walk Test
timeFrame: Post Intervention and 8 week follow up
measure: Self selected over ground gait speed - 5 metre walk test
timeFrame: Post Intervention
measure: Balance related Self Efficacy - Activities-specific Balance Confidence Scale
timeFrame: Post intervention and 8 week follow up
measure: Average Daily Step Count - StepWatch 3 Step Activity Monitor
timeFrame: Post Intervention and 8 Week Follow up
measure: Dynamic Balance - Functional Balance Test
timeFrame: Baseline, Post-intervention and 8 week Follow-up
measure: Life Space Questionnaire
timeFrame: Baseline, Post-intervention, and at 8 week follow up
measure: Number of trainers required per treatment session
timeFrame: Documented at every treatment session for both experimental and active comparison interventions.
measure: Patient Specific Functional Scale
timeFrame: Baseline, Post-intervention, Follow-up (8weeks)
measure: Rating of Walking functional level - Modified Functional Walking Categories
timeFrame: Baseline, Post-intervention, Follow-up (8 weeks)
measure: Adverse event - Self-report of a fall(s) since baseline assessment
timeFrame: Post Intervention Assessment
measure: Adverse event - Falls (yes or no)
timeFrame: Follow - up - 8 weeks after post-intervention assessment
measure: Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death
timeFrame: Post-intervention, Follow up (8 weeks)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University, Hamilton, ON, Canada
name: Vincent G DePaul, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
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.