StrokePhase 1/2NCT00629005
Strength Training and Stroke
A Phase 1/2 study testing Constraint-Induced Movement Therapy + strength training and Constraint-Induced Movement Therapy + range of motion in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constraint-Induced Movement Therapy + strength training and Constraint-Induced Movement Therapy + range of motion
- 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 siteUnited States
- Study dates
- Feb 2008to Sep 2011
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-85;
- a single unilateral middle cerebral artery ischemic stroke;
- no history of drug/alcohol abuse;
- ability to follow 3-step commands and provide informed consent;
- no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
- at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
- ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
- permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.
Who cannot join
- spasticity in elbow or hand (Modified Ashworth Scale > 2);
- Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
- ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
- ataxia, major sensory deficits, or hemi-inattention/neglect;
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Should We Train Strength or Skill in Post-Stroke Rehabilitation?
People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone
Read the detailed description
To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.
- Conditions
- Stroke
- Being tested
- Constraint-Induced Movement Therapy + strength training, Constraint-Induced Movement Therapy + range of motion
- Keywords
- rehabilitation, upper extremity, motor skills
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy + strength trainingBehavioural
Also called forced use, functional task practice, progressive resistive exercise
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
Constraint-Induced Movement Therapy + range of motionBehavioural
Also called forced use, functional task practice
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week Receives: Behavioral: Constraint-Induced Movement Therapy + strength training |
| Arm 2 | Active comparator | Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week Receives: Behavioral: Constraint-Induced Movement Therapy + range of motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment - UE Subscale
Measured: Immediately after the end of therapy and 6 months later
Secondary outcomes (2)
Wolf Motor Function Test
Measured: Immediately after the end of therapy and 6 months later
Cortical mapping using transcranial magnetic stimulation
Measured: Immediately after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2011
- Study completionSep 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen E. Nadeau, MD BS BS, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629005
- Sponsor's protocol ID
- B5033-W
- Status last verified
- Jan 2013
- First submitted
- 19 Feb 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should We Train Strength or Skill in Post-Stroke Rehabilitation?
- ClinicalTrials.gov ID
- NCT00629005
- Acronym / sponsor ID
- B5033-W
- Conditions
- Stroke
- Keywords
- rehabilitation, upper extremity, motor skills
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Mar 2008 (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.
People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone
Detailed description
To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Constraint-Induced Movement Therapy + strength trainingConstraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week |
| Arm 2 | Active comparator | Behavioral: Constraint-Induced Movement Therapy + range of motionConstraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 40-85;
- a single unilateral middle cerebral artery ischemic stroke;
- no history of drug/alcohol abuse;
- ability to follow 3-step commands and provide informed consent;
- no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
Key exclusion criteria (4 listed)
- spasticity in elbow or hand (Modified Ashworth Scale > 2);
- Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
- ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
- ataxia, major sensory deficits, or hemi-inattention/neglect;
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 |
|---|---|---|
| Constraint-Induced Movement Therapy + strength trainingAlso: forced use, functional task practice, progressive resistive exerciseParticipants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises | Behavioural | Arm 1 |
| Constraint-Induced Movement Therapy + range of motionAlso: forced use, functional task practiceParticipants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for | Behavioural | Arm 2 |
Primary outcome
Fugl-Meyer Motor Assessment - UE Subscale
Time frame: Immediately after the end of therapy and 6 months later
2 secondary outcomes
Wolf Motor Function Test
Time frame: Immediately after the end of therapy and 6 months later
Cortical mapping using transcranial magnetic stimulation
Time frame: Immediately after the end of therapy
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 29 Jan 2013.
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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.
Stephen E. Nadeau, MD BS BS principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Constraint-Induced Movement Therapy + strength training and Constraint-Induced Movement Therapy + range of motion in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
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 8 inclusion and 4 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 29 Jan 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fugl-Meyer Motor Assessment - UE Subscale (time frame: Immediately after the end of therapy and 6 months later). 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 29 Jan 2013; AzTrials last refreshed its copy on 3 Nov 2026.