A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke
NCT ID: NCT00561405
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2006-12-31
2011-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Ontario Ministry of Health and Long Term Care
OTHER_GOV
McMaster University
OTHER
Responsible Party
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Vince DePaul
Physiotherapist (PT), PhD (candidate)
Principal Investigators
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Vincent G DePaul, PhD (c)
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Hamilton, ON, Canada
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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06356
Identifier Type: -
Identifier Source: org_study_id