StrokeNCT02785419
Action Selection and Arm Rehabilitation After Stroke
A study testing Arm Training with Action Selection in people with Stroke, run by University of South Carolina at 1 site in United States.
Trial summary
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life. Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Arm Training with Action Selection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to Dec 2020
- 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
- At least 18 years old
- Had stroke at least 6 months ago
- Right-hand dominant prior to stroke
- Some continued arm and hand weakness
- Some ability to move the arm and hand that is weaker from the stroke
Who cannot join
- Acute medical issues that would interfere with participation
- Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
- Cannot undergo MRI scanning
- Severe apraxia or hemispatial neglect
- Pain in the arm that interferes with movement
- Difficulty maintaining attention or following directions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life. Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement. This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function. We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.
Read the detailed description
Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks. In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke. Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls. While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known. Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke. Thirty-eight individuals in the chronic phase of stroke will be recruited. After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training. Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement. Follow-up clinical testing will occur at the end of treatment and three weeks later.
- Conditions
- Stroke
- Being tested
- Arm Training with Action Selection
- Keywords
- Rehabilitation, Upper Extremity, Physical Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm Training with Action SelectionBehavioural
Also called Functional task practice, Arm rehabilitation
Treatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks. In each treatment session, you will practice functional tasks with your weaker arm and hand. Additionally, you will be given cues on a computer screen that dictate your movement response (action selection). Practice will be scaled to match your current level of function and progressed over time as able.
| Study group | Role | What they receive |
|---|---|---|
| Arm Training with Action Selection | Experimental | Task-oriented, functional arm training with the addition of action selection cues to practice. All participants receive the same arm training intervention. Receives: Behavioral: Arm Training with Action Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Behavioral assessment of arm function. Scores range from 0 to 57 with a higher score equating to better function.
Measured: Change from baseline to end of treatment (3 weeks)
Brain activation during functional MRI
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in magnitude of activation.
Measured: Change from baseline to end of treatment (3 weeks)
Brain connectivity during functional MRI
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in connectivity between brain regions.
Measured: Change from baseline to end of treatment (3 weeks)
Secondary outcomes (6)
Upper Extremity Fugl-Meyer Motor Assessment
Measured: Change from baseline to end of treatment (3 weeks)
Stroke Impact Scale Hand Domain
Measured: Change from baseline to end of treatment (3 weeks)
Box & Blocks Test
Measured: Change from baseline to end of treatment (3 weeks)
9-Hole Peg Test
Measured: Change from baseline to end of treatment (3 weeks)
Grip Strength
Measured: Change from baseline to end of treatment (3 weeks)
Confidence in Arm and Hand Movements Questionnaire
Measured: Change from baseline to end of treatment (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start8 Dec 2015
- Primary completionDec 2020
- Study completionDec 2020
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Stewart, PT, PhD, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785419
- Sponsor's protocol ID
- Pro00032516
- Status last verified
- Jul 2021
- First submitted
- 9 May 2016
- Last updated
- 23 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT02785419
- Acronym / sponsor ID
- Pro00032516
- Conditions
- Stroke
- Keywords
- Rehabilitation, Upper Extremity, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 27 May 2016 (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.
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life. Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement. This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function. We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.
Detailed description
Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks. In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke. Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls. While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known. Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke. Thirty-eight individuals in the chronic phase of stroke will be recruited. After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training. Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement. Follow-up clinical testing will occur at the end of treatment and three weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Training with Action Selection | Experimental | Behavioral: Arm Training with Action SelectionTask-oriented, functional arm training with the addition of action selection cues to practice. All participants receive the same arm training intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Had stroke at least 6 months ago
- Right-hand dominant prior to stroke
- Some continued arm and hand weakness
- Some ability to move the arm and hand that is weaker from the stroke
Key exclusion criteria (6 listed)
- Acute medical issues that would interfere with participation
- Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
- Cannot undergo MRI scanning
- Severe apraxia or hemispatial neglect
- Pain in the arm that interferes with movement
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 Training with Action SelectionAlso: Functional task practice, Arm rehabilitationTreatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks. In each treatment session, you will practice functional tasks with your weaker arm and hand. Additionally, you will be given cues on a computer screen that dictate your movement response (action selection). Practice will be scaled to match your current level of function and progressed over time as able. | Behavioural | Arm Training with Action Selection |
Primary outcome
Action Research Arm Test
Time frame: Change from baseline to end of treatment (3 weeks)
Behavioral assessment of arm function. Scores range from 0 to 57 with a higher score equating to better function.
Brain activation during functional MRI
Time frame: Change from baseline to end of treatment (3 weeks)
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in magnitude of activation.
Brain connectivity during functional MRI
Time frame: Change from baseline to end of treatment (3 weeks)
Brain activation during movement will be captured with functional MRI. Analyses will investigate changes in connectivity between brain regions.
6 secondary outcomes
Upper Extremity Fugl-Meyer Motor Assessment
Time frame: Change from baseline to end of treatment (3 weeks)
Stroke Impact Scale Hand Domain
Time frame: Change from baseline to end of treatment (3 weeks)
Box & Blocks Test
Time frame: Change from baseline to end of treatment (3 weeks)
9-Hole Peg Test
Time frame: Change from baseline to end of treatment (3 weeks)
Grip Strength
Time frame: Change from baseline to end of treatment (3 weeks)
Confidence in Arm and Hand Movements Questionnaire
Time frame: Change from baseline to end of treatment (3 weeks)
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 23 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Training with Action Selection in people with Stroke, run by University of South Carolina 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 5 inclusion and 6 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 23 Jul 2021. 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.
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?
Action Research Arm Test (time frame: Change from baseline to end of treatment (3 weeks)). The study lists 3 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 23 Jul 2021.