StrokeNCT03268798
Unilateral Wrist Extension Training After Stroke
A study testing Unilateral wrist extension training in people with Stroke, run by University of Victoria.
Trial summary
Following stroke, muscle weakness and impaired motor function are expressed in both the more (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance training is well recognized, training the MA limb directly may be initially difficult due to muscular weakness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Unilateral wrist extension training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 1 Jul 2017
- 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
- Over 6 months post-stroke;
- One side of arm shows muscle weakness
- Pass the screening test of Physical Activity Readiness Questionnaire
- Pass the screening test for dementia
- Free from dementia (score < 24 on the Montreal Cognitive Assessment) and any other contradiction for TMS test
Who cannot join
- Had medication affecting muscle tone within the past 3 months
- Wear a pacemaker
About this study
Following stroke, muscle weakness and impaired motor function are expressed in both the more (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance training is well recognized, training the MA limb directly may be initially difficult due to muscular weakness. "Cross-education" is training one side of the body increases strength in the untrained and opposite side. This concept can be applied in strength training when training the more affected sides cannot be initiated. Recently, our lab found six weeks of dorsiflexion resistance training in the LA leg improved the strength of both trained and untrained legs of chronic stroke participants.
The current project explored if cross-education exists in the upper limb in chronic stroke participants and if there are related changes in cortical and spinal cord plasticity. We hypothesized that unilateral strength in the less affected arm could enhance wrist extension strength bilaterally with related neural adoption and improved clinical function.
Read the detailed description
Stroke produces muscle weakness seen on both more (paretic, MA) and less affected (non-paretic, LA) sides. "Cross-education" is training one side of the body increases strength or motor skill in the same muscles on the untrained side. This can be applied to enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance training with the LA leg improved strength bilaterally in chronic stroke. To explore if cross-education occurs also in the upper limb after stroke, participants will complete a 5-week unilateral wrist extension training.
Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia. Before and after training, maximal voluntary contraction wrist extension force was measured with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and partial Wolf Motor Function Test were performed by the same physical therapist at each location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal inhibition from transcranial magnetic stimulation were measured in participants at UBC.
- Conditions
- Stroke
- Being tested
- Unilateral wrist extension training
- Keywords
- stroke, strength training, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral wrist extension trainingDevice
Participants will join a five-week training protocol with 3 sessions per week. During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side.
| Study group | Role | What they receive |
|---|---|---|
| Wrist extension training | Experimental | Not described Receives: Device: Unilateral wrist extension training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in wrist extension force
To test if training could improve wrist extension strength, maximal wrist extension force were measured in both arms during the 3 baseline pretests, 1 post-test. There was a week in between each baseline tests, post-test will be performed within one week after the training finished. To test if the force changes maintained after training, follow-up test was performed 5 weeks after training finished.
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test
Secondary outcomes (7)
Changes in the modulation of spinal-mediated muscle reflexes
To test if training could induce neural adaptation at spinal level, spinal-mediated muscle reflexes include reciprocal inhibition and cutaneous reflexes in the wrist extensor muscle were measured. Muscle reflex amplitudes were compared before and after training. There was no follow-up test for this measurement
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Neural adaptation in the corticospinal pathway
To test if training could induced neural adaptation at corticospinal level, cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal from transcranial magnetic stimulation were measured in wrist extensor muscle. Changes in the muscle reflex amplitudes and cortical silent period duration were compared before and after training. There was no follow-up test for this measurement.
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Upper limb impairment assessments
Fugl-Meyer test score were assessed by licensed physiotherapists. Scores were compared before and after training. There was no follow-up test for this measurement.
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Upper limb function assessments
Wolf Motor Function Test were assessed by licensed physiotherapists. Scores were compared before and after training.
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test
Ten-meter walking test
Walking speed was compared before and after training. There was no follow-up test for this measurement
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;
Six-minute walking test
Walking distance was compared before and after training. There was no follow-up test for this measurement
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Timed up and go
Walking speed was compared before and after training. There was no follow-up test for this measurement.
Measured: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startMar 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. E. Paul Zehr, University of Victoria
- Investigators
- E.Paul Zehr, Principal investigator, Rehabilitation Neuroscience Laboratory, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268798
- Sponsor's protocol ID
- D015017-2011-2015
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Wrist Extension Training After Stroke
- ClinicalTrials.gov ID
- NCT03268798
- Acronym / sponsor ID
- D015017-2011-2015
- Conditions
- Stroke
- Keywords
- stroke, strength training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Mar 2015
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 31 Aug 2017 (actual)
- 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.
Following stroke, muscle weakness and impaired motor function are expressed in both the more (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance training is well recognized, training the MA limb directly may be initially difficult due to muscular weakness. "Cross-education" is training one side of the body increases strength in the untrained and opposite side. This concept can be applied in strength training when training the more affected sides cannot be initiated. Recently, our lab found six weeks of dorsiflexion resistance training in the LA leg improved the strength of both trained and untrained legs of chronic stroke participants.
The current project explored if cross-education exists in the upper limb in chronic stroke participants and if there are related changes in cortical and spinal cord plasticity. We hypothesized that unilateral strength in the less affected arm could enhance wrist extension strength bilaterally with related neural adoption and improved clinical function.
Detailed description
Stroke produces muscle weakness seen on both more (paretic, MA) and less affected (non-paretic, LA) sides. "Cross-education" is training one side of the body increases strength or motor skill in the same muscles on the untrained side. This can be applied to enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance training with the LA leg improved strength bilaterally in chronic stroke. To explore if cross-education occurs also in the upper limb after stroke, participants will complete a 5-week unilateral wrist extension training.
Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia. Before and after training, maximal voluntary contraction wrist extension force was measured with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and partial Wolf Motor Function Test were performed by the same physical therapist at each location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal inhibition from transcranial magnetic stimulation were measured in participants at UBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wrist extension training | Experimental | Device: Unilateral wrist extension training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Over 6 months post-stroke;
- One side of arm shows muscle weakness
- Pass the screening test of Physical Activity Readiness Questionnaire
- Pass the screening test for dementia
- Free from dementia (score < 24 on the Montreal Cognitive Assessment) and any other contradiction for TMS test
Key exclusion criteria (2 listed)
- Had medication affecting muscle tone within the past 3 months
- Wear a pacemaker
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 |
|---|---|---|
| Unilateral wrist extension trainingParticipants will join a five-week training protocol with 3 sessions per week. During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side. | Device | Wrist extension training |
Primary outcome
Changes in wrist extension force
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test
To test if training could improve wrist extension strength, maximal wrist extension force were measured in both arms during the 3 baseline pretests, 1 post-test. There was a week in between each baseline tests, post-test will be performed within one week after the training finished. To test if the force changes maintained after training, follow-up test was performed 5 weeks after training finished.
7 secondary outcomes
Changes in the modulation of spinal-mediated muscle reflexes
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Neural adaptation in the corticospinal pathway
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Upper limb impairment assessments
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Upper limb function assessments
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test
Ten-meter walking test
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;
Six-minute walking test
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
Timed up and go
Time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
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 31 Aug 2017.
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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 principal investigator
Rehabilitation Neuroscience Laboratory, University of Victoria
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral wrist extension training in people with Stroke, run by University of Victoria.
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 5 inclusion and 2 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Changes in wrist extension force (time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test). 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 31 Aug 2017.