Cerebrovascular AccidentNCT02316405
Can Arm and Leg Cycling Exercise Improve Walking After Stroke
A study testing Arm and Leg Cycling Exercise for Walking after Stroke in people with Cerebrovascular Accident, 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. Thus, the objective of this research is to determine if arm and leg cycling can be used to improve walking ability in a post-stroke population. This outcome would directly impact the health and quality of life for those who have suffered a stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Arm and Leg Cycling Exercise for Walking after Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 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
- Cerebrovascular accident
Who cannot join
- Inability to stand
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
MacLaurin Building
Victoria, British Columbia
Taryn Klarner, Masters, (250) 472-5487, rnl@uvic.ca
Taryn Klarner, Masters
About this study
Official title: Can Arm and Leg Cycling Exercise Improve Walking After Stroke?
It has been found that arm and leg cycling is similar to walking. Thus, the objective of this research is to determine if arm and leg cycling can be used to improve walking ability in a post-stroke population. This outcome would directly impact the health and quality of life for those who have suffered a stroke.
Read the detailed description
It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns, joint ranges of motion, and neural pathways activated. 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 objective of this research is to determine if arm and leg cycling can be used to increase the strength of inter-limb connections and if this helps to improve walking ability in a post-stroke population. 15-20 participants will be recruited to participate in a five week training intervention where measures will be taken before and after the intervention to assess efficacy. Arm and leg cycling could provide a novel method to improve inter-limb coupling and walking ability. These outcomes would directly impact the health and quality of life for those who have suffered a stroke.
- Conditions
- Cerebrovascular Accident
- Being tested
- Arm and Leg Cycling Exercise for Walking after Stroke
- 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 for Walking after StrokeOther
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | 5 weeks of arm and leg cycling, 3 times per week for 30 minute of total exercise per session Receives: Other: Arm and Leg Cycling Exercise for Walking after Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Ability
Treadmill test of walking coordination, speed, and symmetry. Interlimb coordination assessed with peripheral nerve stimulation during arm and leg cycling and walking. Strength of dorsi-flexion and plantar-flexion and grip strength also assessed.
Measured: Within five days
Secondary outcomes (1)
Clinical Status assessed by a Physiotherapist
Clinical assessment of skin sensitivity, spasticity, balance and coordination, and walking endurance.
Measured: Within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- 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
- Responsible party
- Principal investigator, Dr. E. Paul Zehr, University of Victoria
- Investigators
- E P Zehr, Doctorate, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316405
- Sponsor's protocol ID
- D015017-2011-2014
- Other IDs
- 123456
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Arm and Leg Cycling Exercise Improve Walking After Stroke?
- ClinicalTrials.gov ID
- NCT02316405
- Acronym / sponsor ID
- D015017-2011-2014
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Dec 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. Thus, the objective of this research is to determine if arm and leg cycling can be used to improve walking ability in a post-stroke population. This outcome would directly impact the health and quality of life for those who have suffered a stroke.
Detailed description
It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns, joint ranges of motion, and neural pathways activated. 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 objective of this research is to determine if arm and leg cycling can be used to increase the strength of inter-limb connections and if this helps to improve walking ability in a post-stroke population. 15-20 participants will be recruited to participate in a five week training intervention where measures will be taken before and after the intervention to assess efficacy. Arm and leg cycling could provide a novel method to improve inter-limb coupling and walking ability. These outcomes would directly impact the health and quality of life for those who have suffered a stroke.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Arm and Leg Cycling Exercise for Walking after Stroke5 weeks of arm and leg cycling, 3 times per week for 30 minute of total exercise per session |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cerebrovascular accident
Key exclusion criteria (1 listed)
- Inability to stand
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 for Walking after Stroke | Other | Test Group |
Primary outcome
Walking Ability
Time frame: Within five days
Treadmill test of walking coordination, speed, and symmetry. Interlimb coordination assessed with peripheral nerve stimulation during arm and leg cycling and walking. Strength of dorsi-flexion and plantar-flexion and grip strength also assessed.
1 secondary outcome
Clinical Status assessed by a Physiotherapist
Time frame: Within 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 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 P Zehr, Doctorate 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 for Walking after Stroke in people with Cerebrovascular Accident, 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 1 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 12 Dec 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 E P Zehr, Doctorate ((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?
Walking Ability (time frame: Within five days). 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 12 Dec 2014.