StrokeNCT02232867
Arm and Leg Cycling Exercise After Stroke
A study testing Arm and Leg Cycling Exercise Program in people with Stroke, run by University of Victoria at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Arm and Leg Cycling Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stroke
- lives within the Victoria, Vancouver Island, and Vancouver mainland communities
Who cannot join
- inability to stand for 5 minutes unassisted
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Rehabilitation Neuroscience Laboratory
Victoria, British Columbia, V8W 3N4
Marj Wilder, B.Sc., mwilder@uvic.ca
E Paul Zehr, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Arm and Leg Cycling Exercise Program
- Keywords
- rehabilitation, stroke, walking, interlimb connections
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm and Leg Cycling Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm and Leg Cycling Exercise Program | Experimental | 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. Receives: Behavioral: Arm and Leg Cycling Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treadmill Walking Characteristics
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
Measured: Baseline, immediately post-intervention (average of 4 days following last exercise session)
Secondary outcomes (6)
Interlimb Connections
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.
Measured: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Fugl-Meyer Assessment
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.
Measured: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Brunnstrom recovery stages
The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.
Measured: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Timed up and go test
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.
Measured: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
10 meter walk test
The 10 meter walk test is a timed test to evaluate walking speed
Measured: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Six minute walk test
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.
Measured: Baseline, immediately post-intervention (average of 4 days following last exercise session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Stroke Network
- Responsible party
- Principal investigator, Dr. E. Paul Zehr, University of Victoria
- Investigators
- E. Paul Zehr, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232867
- Sponsor's protocol ID
- 07-480-04d
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Locomotor Training to Improve Walking Ability After Stroke
- ClinicalTrials.gov ID
- NCT02232867
- Acronym / sponsor ID
- 07-480-04d
- Conditions
- Stroke
- Keywords
- rehabilitation, stroke, walking, interlimb connections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Stroke Network
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm and Leg Cycling Exercise Program | Experimental | Behavioral: Arm and Leg Cycling Exercise ProgramMultiple 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- stroke
- lives within the Victoria, Vancouver Island, and Vancouver mainland communities
Key exclusion criteria (1 listed)
- inability to stand for 5 minutes unassisted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm and Leg Cycling Exercise ProgramParticipants 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. | Behavioural | Arm and Leg Cycling Exercise Program |
Primary outcome
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
6 secondary outcomes
Interlimb Connections
Time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Fugl-Meyer Assessment
Time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Brunnstrom recovery stages
Time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Timed up and go test
Time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
10 meter walk test
Time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
Six minute walk test
Time frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Paul Zehr, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm and Leg Cycling Exercise Program in people with Stroke, run by University of Victoria at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taryn Klarner, M.Sc. ((250) 472-5487, rnl@uvic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treadmill Walking Characteristics (time frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.