Cerebrovascular AccidentNCT00361660
The Effect of Different Schedules of Functional Task Practice for Improving Hand and Arm Function After Stroke
A study testing functional task practice - distributed and functional task practice - condensed in people with Cerebrovascular Accident and Hemiplegia, run by US Department of Veterans Affairs.
Trial summary
The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cerebrovascular Accident, Hemiplegia
- What is being tested?
- functional task practice - distributed and functional task practice - condensed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiparesis due to unilateral stroke at least 3 months prior
- 18-90 years of age
- able to extend the paretic wrist 200 and at least 1 finger 100
- able to follow 2-step commands
- score < 3 on the Motor Activity Log Amount of Use scale
Who cannot join
- have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy
- have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.
About this study
Official title: The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke
The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.
Read the detailed description
Intense skill practice with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplastic changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. In this study, using parallel group design methodology, we will test the effect of 2 practice parameter (i.e. spacing of practice and number of repetitions per task practiced per session) modifications on UE function following skill practice.
Forty subjects will complete multiple baseline testing and then be randomized, using random number table, to one of 4 groups: condensed functional task practice modeled after Constraint-Induced Movement Therapy (6 hours of practice/day, 5 days/week, 2 weeks), condensed functional task practice with a restricted number of tasks practiced, distributed, distributed functional task practice (Monday, Wednesday, Friday, 6 hours/session, 10 sessions), distributed functional task practice with a restricted number of tasks practiced. During therapy sessions, subjects will practice performing common activities with their paretic upper extremity. They will wear a mitt on their non-paretic upper extremity for up to 90% of their waking hours. Post-testing sessions will follow within one week of completing therapy with an additional follow-up testing session 3 months later.
- Conditions
- Cerebrovascular Accident, Hemiplegia
- Being tested
- functional task practice - distributed, functional task practice - condensed
- Keywords
- Motor skills, Occupational Therapy, Physical Therapy Techniques, Rehabilitation, Upper Extremity, Stroke
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional task practice - distributedBehavioural
Also called constraint-Induced Movement Therapy
This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
functional task practice - condensedBehavioural
Also called Constraint-Induced Movement Therapy
This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday). Receives: Behavioral: functional task practice - distributed |
| 2 | Active comparator | The same therapy is provided daily Monday through Friday Receives: Behavioral: functional task practice - condensed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity subscale of the Fugl-Meyer Motor Assessment
Measured: immediately after therapy ends
Secondary outcomes (1)
Wolf Motor Function Test
Measured: Immediately after therapy ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionDec 2007 (estimated)
Why it stopped: project was only internally funded and would complete for subjects with 2 newer externally funded projects
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Lorie G Richards, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361660
- Sponsor's protocol ID
- 407-2005A
- Status last verified
- Jun 2015
- First submitted
- 7 Aug 2006
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Functional Task Practice Dosing on Motor Control in Hemiplegia From Chronic Stroke
- ClinicalTrials.gov ID
- NCT00361660
- Acronym / sponsor ID
- 407-2005A
- Conditions
- Cerebrovascular Accident, Hemiplegia
- Keywords
- Motor skills, Occupational Therapy, Physical Therapy Techniques, Rehabilitation, Upper Extremity, Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: project was only internally funded and would complete for subjects with 2 newer externally funded projects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (estimated)
- First posted
- 8 Aug 2006 (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.
The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.
Detailed description
Intense skill practice with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplastic changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. In this study, using parallel group design methodology, we will test the effect of 2 practice parameter (i.e. spacing of practice and number of repetitions per task practiced per session) modifications on UE function following skill practice.
Forty subjects will complete multiple baseline testing and then be randomized, using random number table, to one of 4 groups: condensed functional task practice modeled after Constraint-Induced Movement Therapy (6 hours of practice/day, 5 days/week, 2 weeks), condensed functional task practice with a restricted number of tasks practiced, distributed, distributed functional task practice (Monday, Wednesday, Friday, 6 hours/session, 10 sessions), distributed functional task practice with a restricted number of tasks practiced. During therapy sessions, subjects will practice performing common activities with their paretic upper extremity. They will wear a mitt on their non-paretic upper extremity for up to 90% of their waking hours. Post-testing sessions will follow within one week of completing therapy with an additional follow-up testing session 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: functional task practice - distributedTherapy is provided every other day 3 days per week (Monday, Wednesday, Friday). |
| 2 | Active comparator | Behavioral: functional task practice - condensedThe same therapy is provided daily Monday through Friday |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hemiparesis due to unilateral stroke at least 3 months prior
- 18-90 years of age
- able to extend the paretic wrist 200 and at least 1 finger 100
- able to follow 2-step commands
- score < 3 on the Motor Activity Log Amount of Use scale
Key exclusion criteria (2 listed)
- have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy
- have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.
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 |
|---|---|---|
| functional task practice - distributedAlso: constraint-Induced Movement TherapyThis functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc. | Behavioural | 1 |
| functional task practice - condensedAlso: Constraint-Induced Movement TherapyThis functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc. | Behavioural | 2 |
Primary outcome
Upper extremity subscale of the Fugl-Meyer Motor Assessment
Time frame: immediately after therapy ends
1 secondary outcome
Wolf Motor Function Test
Time frame: Immediately after therapy ends
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Lorie G Richards, PhD principal investigator
North Florida/South Georgia Veterans Health System
Questions about this trial
What is this clinical trial studying?
A study testing functional task practice - distributed and functional task practice - condensed in people with Cerebrovascular Accident and Hemiplegia, run by US Department of Veterans Affairs.
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: withdrawn, as of the sponsor's last update on 26 Jun 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Upper extremity subscale of the Fugl-Meyer Motor Assessment (time frame: immediately after therapy ends). 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 Jun 2015.