- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02232867
Arm and Leg Cycling Exercise After Stroke
September 2, 2014 updated by: Dr. E. Paul Zehr, University of Victoria
Adjunct Locomotor Training to Improve Walking Ability After Stroke
It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns and joint ranges of motion.
In addition, arm and leg cycling and walking activate similar neural pathways.
Another advantage of arm and leg cycling is that it involves coordination of all four limbs in a rhythmic movement.
This may be particularly beneficial given previous findings that arm movement contributes to the activation of leg muscles during walking in humans.
This is achieved with interconnected neural pathways that link the arms to the legs.
These neural interlimb connections remain intact in stroke victims, such that maximizing the contribution of the arms to the legs may increase coordination for walking.
Thus, the objectives of this research are to determine if arm and leg cycling can be used to increase the strength of interlimb connections and if this helps to improve walking ability in a post-stroke population.
It is hypothesized that arm and leg cycling will transfer to improvements in walking in a post stroke population.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
For those who have suffered a stroke, damage to the brain can result in a decreased ability to walk, thus decreasing quality of life in a significant way.
Traditionally, body weight supported treadmill training has been used for walking rehabilitation; however, this therapy requires specialized technicians, equipment, and facilities.
Arm and leg cycle ergometers, a device commonly found in a gym, could provide an inexpensive and readily accessible means for walking rehabilitation.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Taryn Klarner, M.Sc.
- Phone Number: (250) 472-5487
- Email: rnl@uvic.ca
Study Locations
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British Columbia
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Victoria, British Columbia, Canada, V8W 3N4
- Recruiting
- Rehabilitation Neuroscience Laboratory
-
Contact:
- Marj Wilder, B.Sc.
- Email: mwilder@uvic.ca
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Principal Investigator:
- E Paul Zehr, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- stroke
- lives within the Victoria, Vancouver Island, and Vancouver mainland communities
Exclusion Criteria:
- inability to stand for 5 minutes unassisted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm and Leg Cycling Exercise Program
Multiple baseline test sessions will be used for the same participant to establish a meaningful baseline thus confirming consistency of all outcome measures prior to the intervention.
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Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session.
To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected.
The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Treadmill Walking Characteristics
Time Frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)
|
Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics.
Walking frequency, symmetry, and timing will also be analyzed
|
Baseline, immediately post-intervention (average of 4 days following last exercise session)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interlimb Connections
Time Frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
|
To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal).
The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.
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Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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Fugl-Meyer Assessment
Time Frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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Brunnstrom recovery stages
Time Frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.
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Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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Timed up and go test
Time Frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
|
The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.
During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
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Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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10 meter walk test
Time Frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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The 10 meter walk test is a timed test to evaluate walking speed
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Baseline, immediately post-intervention (average of 4 days following the last exercise session)
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Six minute walk test
Time Frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)
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The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in six minutes.
The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
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Baseline, immediately post-intervention (average of 4 days following last exercise session)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: E. Paul Zehr, PhD, University of Victoria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
August 28, 2014
First Submitted That Met QC Criteria
September 2, 2014
First Posted (Estimate)
September 5, 2014
Study Record Updates
Last Update Posted (Estimate)
September 5, 2014
Last Update Submitted That Met QC Criteria
September 2, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-480-04d
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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