StrokeNCT01818349
Impact of Training on Gait and Strength in Stroke Survivors
A study testing isokinetic lower-limb training and isokinetic upper-limb training in people with Stroke, run by Université de Montréal at 1 site in Canada.
Trial summary
Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- isokinetic lower-limb training and isokinetic upper-limb training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a chronic (six months or more) unilateral stroke
- be able to walk 10 meters independently with or without a cane
- present residual weakness at the affected lower limb
- have an activity tolerance of at least two hours with a rest period
Who cannot join
- receptive aphasia
- incontinence
- unstable medical condition
- history of injury
- anesthesia at the lower limbs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de réadaptation Gingras-Lindsay
Montreal, Quebec, H3S 1M9
About this study
Official title: Gait Performance and Lower-limb Muscle Strength Improved in Both Upper-limb and Lower-limb Isokinetic Training Programs in Individuals With Chronic Stroke
Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding.
Objective: To evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength.
Read more
Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups.
Design: Single-blinded randomized controlled trial.
Participants: A convenient sample of 30 individuals with chronic hemiparesis.
Interventions: Participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. The experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles.
Main outcome measures: Baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.
- Conditions
- Stroke
- Being tested
- isokinetic lower-limb training, isokinetic upper-limb training
- Keywords
- stroke, exercise, muscle strength, gait, rehabilitation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic lower-limb trainingOther
concentric training of the affected plantarflexors, hip flexors and hip extensors
isokinetic upper-limb trainingOther
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
| Study group | Role | What they receive |
|---|---|---|
| isokinetic lower-limb training | Active comparator | 3 times/week for 6 weeks Receives: Other: isokinetic lower-limb training |
| isokinetic uppe-limb training | Placebo comparator | 3 times/week for 6 weeks Receives: Other: isokinetic upper-limb training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gait speed
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
Measured: gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
change in peak positive power
peak positive power was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in peak positive power, in weight/kilogram, was assessed as the difference between the baseline and week #7 values.
Measured: peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
Secondary outcomes (1)
change in maximal voluntary concentric strength
maximal voluntary concentric strength was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in maximal voluntary concentric strength, in Newton-metre, was assessed as the difference between the baseline and week #7 values.
Measured: maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2002
- Primary completionDec 2005
- Study completionDec 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marie-hélène Milot, Université de Montréal
- Investigators
- Sylvie Nadeau, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818349
- Sponsor's protocol ID
- IRSC-44059
- Status last verified
- Mar 2013
- First submitted
- 15 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Performance and Lower-limb Muscle Strength Improved in Both Upper-limb and Lower-limb Isokinetic Training Programs in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT01818349
- Acronym / sponsor ID
- IRSC-44059
- Conditions
- Stroke
- Keywords
- stroke, exercise, muscle strength, gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Mar 2013 (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.
Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding.
Objective: To evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength.
Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups.
Design: Single-blinded randomized controlled trial.
Participants: A convenient sample of 30 individuals with chronic hemiparesis.
Interventions: Participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. The experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles.
Main outcome measures: Baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isokinetic lower-limb training | Active comparator | Other: isokinetic lower-limb training3 times/week for 6 weeks |
| isokinetic uppe-limb training | Placebo comparator | Other: isokinetic upper-limb training3 times/week for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have a chronic (six months or more) unilateral stroke
- be able to walk 10 meters independently with or without a cane
- present residual weakness at the affected lower limb
- have an activity tolerance of at least two hours with a rest period
Key exclusion criteria (5 listed)
- receptive aphasia
- incontinence
- unstable medical condition
- history of injury
- anesthesia at the lower limbs
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 |
|---|---|---|
| isokinetic lower-limb trainingconcentric training of the affected plantarflexors, hip flexors and hip extensors | Other | isokinetic lower-limb training |
| isokinetic upper-limb trainingconcentric training of the affected wrist extensors, elbow flexors and shoulder flexors | Other | isokinetic uppe-limb training |
Primary outcome
change in gait speed
Time frame: gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
change in peak positive power
Time frame: peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
peak positive power was evaluated at the affected plantarflexors, hip flexors and hip extensors. Also, change in peak positive power, in weight/kilogram, was assessed as the difference between the baseline and week #7 values.
1 secondary outcome
change in maximal voluntary concentric strength
Time frame: maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Sylvie Nadeau, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic lower-limb training and isokinetic upper-limb training in people with Stroke, run by Université de Montréal 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in gait speed (time frame: gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)). The study lists 2 primary outcomes in all. 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 26 Mar 2013.