StrokeNCT03062930
Remediation of the Non-Paretic Arm in Stroke
A study testing Track 1 and Track 2 in people with Stroke, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Stroke survivors with severe contralesional paresis often have substantial control and coordination deficits in the non-paretic arm. Because this arm must serve as the primary controller, these deficits can be functionally devastating. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Track 1 and Track 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2016to 1 Dec 2018
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be between 21 and 85 years old of either gender
- Subjects will demonstrate cognitive abilities required to follow commands and engage in the experimental task
- Subjects will have had a unilateral stroke at least 3 months prior to participation resulting in upper extremity motor deficits
Who cannot join
- hospitalization for substance abuse and/or a major psychiatric diagnosis (schizophrenia);
- non-stroke neurological diseases that may affect ability to perform task or upper limb motor function
- certain peripheral movement restrictions, such as neuropathy
- neuroradiological confirmation of concomitant damage to the cerebellum or brain stem or extensive periventricular white matter changes (based on consultation with neuroradiology)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine; Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Remediation of the Non-Paretic Arm to Improve Functional Independence in Chronic Stroke Survivors
Stroke survivors with severe contralesional paresis often have substantial control and coordination deficits in the non-paretic arm. Because this arm must serve as the primary controller, these deficits can be functionally devastating. The investigators now hypothesize that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that remediation, focused on the non-paretic arm should improve functional independence. The investigators propose a randomized study design with two tracts, two periods and four assessments. The investigators envision this study as the first step in establishing the basis for a rehabilitation approach that focuses on remediation of BOTH arms, which constitutes a substantial change from current remediation protocols focused only on the contralesional arm.
Read the detailed description
The investigators previously elaborated hemisphere specific motor deficits in the non-paretic arm of chronic stroke survivors with unilateral hemisphere damage. The investigators showed that these deficits are associated with substantial limitations in performance of activities of daily living (ADL), an effect exacerbated by contralesional paresis due to forced reliance on the non-paretic arm. The investigators now hypothesize that the combination low moderate to severe paresis (Fugl-Meyer Score < 35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that intense remediation focused on improving the speed, coordination, and accuracy of the non-paretic arm should improve functional independence, as well as improving paretic arm function due to increased participation in daily activities. Unfortunately, the usual standard of care in rehabilitation for survivors with low-moderate to severe paresis tends to focus on task training in essential ADL activities, rather than on intensive remediation. Previous research has shown that non-paretic arm deficits depend on the hemisphere that is damaged by stroke, such that left hemisphere damage (LHD) impairs trajectory features, including speed and smoothness, while right hemisphere damage (RHD) impairs the ability to bring the arm to rest at an accurate and stable position. The investigators have designed a training program to address both of these motor components and to improve the speed and dexterity of the non-paretic arm. The investigators propose a randomized study design with two tracts, two periods and four assessments. Participants will first complete 2 baseline assessments, spaced 3 weeks apart. Following completion of the second assessment, participants will be randomly assigned to one of two tracks: Track 1 will receive three weeks of arm training, followed by 3 weeks of a comparison condition. Participants assigned to track 2 will receive three weeks of the comparison condition, followed by 3 weeks of arm training. Then, all participants will complete an end-of-period assessment, and a follow-up assessment for retention, 3 weeks after completion of the two periods. Pilot results indicate that non-paretic arm training produces substantial improvements in motor performance and functional independence as well as reducing paretic arm impairment. This is an essential first-step in developing a rehabilitation protocol focused on remediating both arms of severely impaired stroke survivors.
- Conditions
- Stroke
- Being tested
- Track 1, Track 2
- Keywords
- stroke, hemiparesis, lesion hemisphere, ipsilesional deficits, contralesional deficits, rehabilitation, remediation, paretic arm
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Track 1Behavioural
Also called remediation of non-paretic arm followed by sham training
Training of non-paretic arm followed by sham condition
Track 2Behavioural
Also called sham condition followed by remediation of non-paretic arm
Same procedures as track 1, but completed in opposite order, starting with sham condition followed by the non-paretic arm training
| Study group | Role | What they receive |
|---|---|---|
| Track 1 | Active comparator | Training of non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks followed by sham condition (playing board games/computer games) for 3 weeks Receives: Behavioral: Track 1; Behavioral: Track 2 |
| Track 2 | Sham comparator | Sham condition (playing board games/computer games) for 3 weeks followed by training of the non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks Receives: Behavioral: Track 1; Behavioral: Track 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance time on Jebsen Taylor Hand Function Test
test of unimanual arm function on the non-paretic arm
Measured: week -3, week 0, week 3, week 6, week 9
Secondary outcomes (4)
Change in Barthel Index
measure of functional independence
Measured: week -3, week 0, week 3, week 6, week 9
Change in Kinematic analysis
Distance and Direction Errors and Hand Path Straightness on virtual reaching task (non-paretic arm)
Measured: week -3, week 0, week 3, week 6, week 9
Change in Grooved Pegboard
timed measure of dexterity of the non-paretic arm
Measured: week -3, week 0, week 3, week 6, week 9
Change in Upper Extremity Fugl Meyer Assessment
test of paretic arm function
Measured: week -3, week 0, week 3, week 6, week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start20 Aug 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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 Milton S. Hershey Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Sainburg, Milton S. Hershey Medical Center
- Investigators
- Robert Sainburg, Phd, Principal investigator, Penn State College of Medicine, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062930
- Sponsor's protocol ID
- STUDY00002937
- Other IDs
- 16GRNT31010001
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Scholar Sphere
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remediation of the Non-Paretic Arm to Improve Functional Independence in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT03062930
- Acronym / sponsor ID
- STUDY00002937
- Conditions
- Stroke
- Keywords
- stroke, hemiparesis, lesion hemisphere, ipsilesional deficits, contralesional deficits, rehabilitation, remediation, paretic arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 20 Aug 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 Feb 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.
Stroke survivors with severe contralesional paresis often have substantial control and coordination deficits in the non-paretic arm. Because this arm must serve as the primary controller, these deficits can be functionally devastating. The investigators now hypothesize that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that remediation, focused on the non-paretic arm should improve functional independence. The investigators propose a randomized study design with two tracts, two periods and four assessments. The investigators envision this study as the first step in establishing the basis for a rehabilitation approach that focuses on remediation of BOTH arms, which constitutes a substantial change from current remediation protocols focused only on the contralesional arm.
Detailed description
The investigators previously elaborated hemisphere specific motor deficits in the non-paretic arm of chronic stroke survivors with unilateral hemisphere damage. The investigators showed that these deficits are associated with substantial limitations in performance of activities of daily living (ADL), an effect exacerbated by contralesional paresis due to forced reliance on the non-paretic arm. The investigators now hypothesize that the combination low moderate to severe paresis (Fugl-Meyer Score < 35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that intense remediation focused on improving the speed, coordination, and accuracy of the non-paretic arm should improve functional independence, as well as improving paretic arm function due to increased participation in daily activities. Unfortunately, the usual standard of care in rehabilitation for survivors with low-moderate to severe paresis tends to focus on task training in essential ADL activities, rather than on intensive remediation. Previous research has shown that non-paretic arm deficits depend on the hemisphere that is damaged by stroke, such that left hemisphere damage (LHD) impairs trajectory features, including speed and smoothness, while right hemisphere damage (RHD) impairs the ability to bring the arm to rest at an accurate and stable position. The investigators have designed a training program to address both of these motor components and to improve the speed and dexterity of the non-paretic arm. The investigators propose a randomized study design with two tracts, two periods and four assessments. Participants will first complete 2 baseline assessments, spaced 3 weeks apart. Following completion of the second assessment, participants will be randomly assigned to one of two tracks: Track 1 will receive three weeks of arm training, followed by 3 weeks of a comparison condition. Participants assigned to track 2 will receive three weeks of the comparison condition, followed by 3 weeks of arm training. Then, all participants will complete an end-of-period assessment, and a follow-up assessment for retention, 3 weeks after completion of the two periods. Pilot results indicate that non-paretic arm training produces substantial improvements in motor performance and functional independence as well as reducing paretic arm impairment. This is an essential first-step in developing a rehabilitation protocol focused on remediating both arms of severely impaired stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Track 1 | Active comparator | Behavioral: Track 1, Behavioral: Track 2Training of non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks followed by sham condition (playing board games/computer games) for 3 weeks |
| Track 2 | Sham comparator | Behavioral: Track 1, Behavioral: Track 2Sham condition (playing board games/computer games) for 3 weeks followed by training of the non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be between 21 and 85 years old of either gender
- Subjects will demonstrate cognitive abilities required to follow commands and engage in the experimental task
- Subjects will have had a unilateral stroke at least 3 months prior to participation resulting in upper extremity motor deficits
Key exclusion criteria (4 listed)
- hospitalization for substance abuse and/or a major psychiatric diagnosis (schizophrenia);
- non-stroke neurological diseases that may affect ability to perform task or upper limb motor function
- certain peripheral movement restrictions, such as neuropathy
- neuroradiological confirmation of concomitant damage to the cerebellum or brain stem or extensive periventricular white matter changes (based on consultation with neuroradiology)
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 |
|---|---|---|
| Track 1Also: remediation of non-paretic arm followed by sham trainingTraining of non-paretic arm followed by sham condition | Behavioural | Track 1, Track 2 |
| Track 2Also: sham condition followed by remediation of non-paretic armSame procedures as track 1, but completed in opposite order, starting with sham condition followed by the non-paretic arm training | Behavioural | Track 1, Track 2 |
Primary outcome
Change in performance time on Jebsen Taylor Hand Function Test
Time frame: week -3, week 0, week 3, week 6, week 9
test of unimanual arm function on the non-paretic arm
4 secondary outcomes
Change in Barthel Index
Time frame: week -3, week 0, week 3, week 6, week 9
Change in Kinematic analysis
Time frame: week -3, week 0, week 3, week 6, week 9
Change in Grooved Pegboard
Time frame: week -3, week 0, week 3, week 6, week 9
Change in Upper Extremity Fugl Meyer Assessment
Time frame: week -3, week 0, week 3, week 6, week 9
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 28 Mar 2019.
- Individual participant dataSharing planned: Yes. Scholar Sphere
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
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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.
Robert Sainburg, Phd principal investigator
Penn State College of Medicine, Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Track 1 and Track 2 in people with Stroke, run by Milton S. Hershey Medical Center 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 3 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 28 Mar 2019. 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. 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 performance time on Jebsen Taylor Hand Function Test (time frame: week -3, week 0, week 3, week 6, week 9). 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 28 Mar 2019.