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StrokeNCT03634397

Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

A study testing Less-Impaired Arm Training and Contralesional Arm Comparison in people with Stroke, run by Robert L. Sainburg at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits functional independence in chronic stroke survivors. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Less-Impaired Arm Training and Contralesional Arm Comparison
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
2 sitesUnited States
Study dates
2 Feb 2019to 5 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness
  • deficits in ipsilesional arm performance assessed by the JTHFT
  • 6+ months post stroke
  • Demonstrates cognitive abilities

Who cannot join

  • a history of:
  • neurological disease other than stroke (e.g., head trauma)
  • a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
  • hospital admission for substance abuse
  • peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis
  • currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function
  • significant joint pain that is activity limiting
  • bilateral stroke

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

  • University of Southern California

    Los Angeles, California, 90089

Other trials in United States

About this study

This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.

Read the detailed description

We previously characterized hemisphere-specific motor control deficits in the non-paretic arm of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are substantial and functionally limiting in patients with severe paresis. We have specifically designed an intervention to remediate the hemisphere-specific deficits in the less-impaired arm, using a virtual-reality platform, and then follow this training with manipulation training of a variety of real objects, designed to facilitate generalization and transfer to functional behaviors encountered in the natural environment. We propose a 2-site, two-group randomized intervention with a treatment group, which will receive unilateral training of the less-impaired arm, through our Virtual Reality and Manipulation Training (VRMT) protocol. This intervention protocol is grounded in the premise that targeted remediation of fundamental control deficits exhibited by the less-impaired arm will generalize and transfer beyond practiced tasks to performance of activities of daily living (ADL). This approach contrasts with the more pragmatic approach of task-specific training of essential ADL's, which is limited in scope, more cumbersome, and ignores known fundamental motor control deficits. Our control group will receive conventional intervention, guided by recently released practice guidelines for upper limb intervention in adult stroke. The impact of the proposed research is that we address persistent functional performance deficits in chronic stroke patients with severe paresis, who's less-impaired arm impairments are generally ignored in most current rehabilitation protocols. Our first aim addresses the overall effectiveness of this intervention, relative to our control group: To determine whether non-paretic arm VRMT in chronic stroke survivors with severe paresis will produce durable improvements in less-impaired arm motor performance that will generalize to improve functional activities and functional independence to a greater extent than conventional therapy focused on the paretic arm. Our second aim focuses on the mechanistic basis of potential training-related improvements in motor performance: To determine whether intervention-induced improvements in less-impaired arm performance are associated with improvements in hemisphere-specific reaching kinematics. Finally, our third aim monitors for potential negative effects of our experimental intervention on paretic arm impairment.

Conditions
Stroke
Being tested
Less-Impaired Arm Training, Contralesional Arm Comparison
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Less-Impaired Arm TrainingBehavioural

    Participants receive virtual reality and manipulation training in their less impaired arm.

  • Contralesional Arm ComparisonBehavioural

    Also called sham condition

    Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.

Study groups in NCT03634397
Study groupRoleWhat they receive
Less-Impaired Arm TrainingExperimentalIntervention condition includes therapy of the less-impaired (ipsilesional) arm.
Receives: Behavioral: Less-Impaired Arm Training
Contralesional Arm ComparisonSham comparatorComparison control condition includes therapy of the paretic (contralesional) arm.
Receives: Behavioral: Contralesional Arm Comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1

    Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time).

    There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

  2. Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1

    Participant reported outcome of difficulty of upper extremity based activities. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores. Results do not include covariates.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

  3. Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1

    Measure of functional independence in self care activities scored from 0-100 with higher scores indicating more functional independence. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

  4. Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1

    Upper-Extremity Measure of paretic arm impairment out of 66 possible points with higher scores indicating more movement, and 0 indicating no functional movement in the arm. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Secondary outcomes (3)
  1. Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components

    Each item on the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). Analysis includes 6 sub-components of the FIM, which are the self care components (Eating, Grooming, Bathing, Dressing upper body, Dressing lower body, and toileting) (possible 42 points). Higher scores indicate more independence.

    There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

  2. Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)

    Workspace area is a kinematic measure of active range of motion, which we measured on the paretic (contralesional) arm. This was calculated by computing the area of the ellipse (measured in centimeters) formed by the major and minor axis of the contralesional arm trajectory on each trial. The major axis was defined as the largest distance between any two points in the handpath, while the minor axis was defined as the largest distance, perpendicular to the major axis. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values.

    There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores. These values do not include covariates.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

  3. Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1

    Positional variability is a measure of kinematic variability in reaching movement. This was measured at the participants max reaching velocity and their end position. This was calculated by taking the distance (cm) from the fingertips location at peak velocity/end position on a given trial from its mean location at peak velocity/end position across all trials, for each target. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values.

    There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores or covariates.

    Measured: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start2 Feb 2019
  3. Primary completion22 Feb 2024
  4. Study completion5 Aug 2024

Resources

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
Model description
Participants are randomly assigned to one of two groups. One group (treatment group) receives remediation therapy of the less impaired arm while the control group receives paretic arm therapy.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03634397
Sponsor's protocol ID
STUDY00008385
Other IDs
R01HD059783-06A1
Status last verified
Sep 2025
First submitted
3 Jul 2018
Last updated
12 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified research data (functional outcome measures) generated by the project will be shared through ScholarSphere (https://scholarsphere.psu.edu/), the repository service that both the University Libraries and Information Technology Services administer at Penn State. Researchers will be able to access the data via ScholarSphere, which ensures persistent access to deposited content. The data will be discoverable via Google and other major search engines, as well as by request to Dr. Sainburg or Dr. Winstein.

Publications

  • Maenza C, Winstein CJ, Murphy TE, Kitchen NM, Tanaka J, Yuk J, Varghese R, Sainburg RL. Targeted Remediation of the Ipsilesional Arm in Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2026 Mar 1;83(3):223-230. doi: 10.1001/jamaneurol.2025.5496.

    PubMed 41627841
  • Maenza C, Sainburg RL, Varghese R, Dexheimer B, Demers M, Bishop L, Jayasinghe SAL, Wagstaff DA, Winstein C; IPSI Investigative Team. Ipsilesional arm training in severe stroke to improve functional independence (IPSI): phase II protocol. BMC Neurol. 2022 Apr 12;22(1):141. doi: 10.1186/s12883-022-02643-z.

    PubMed 35413856

Questions about this trial

What is this clinical trial studying?

A study testing Less-Impaired Arm Training and Contralesional Arm Comparison in people with Stroke, run by Robert L. Sainburg at 2 sites 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 4 inclusion and 8 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1 (time frame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03634397, which also lists 2 linked publications.

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 12 Sep 2025.

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