Stroke RehabilitationSPARkNCT06998485
Substrates for Post-Stroke Arm Rehabilitation
A study testing Arm Basis Training in people with Stroke Rehabilitation and Stroke, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitation, Stroke, Neurorecovery
- What is being tested?
- Arm Basis Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- first time unilateral ischemic or hemorrhagic stroke occurring within the 3-6 months
- upper extremity motor impairment as measured by the Upper Extremity Fugl-Meyer Assessment (UE-FMA) Score <= 44
- ability to participate in a 6-week intensive upper extremity intervention in English as determined by a licensed occupational therapist.
Who cannot join
- bilateral stroke
- unstable medical status affecting functional status
- pre-stroke upper extremity injury or conditions that limited use
- visual or auditory impairment limiting ability to participate in study procedures
- significant aphasia (NIHSS sub-item 9 > 1) or cognitive (NIHSS 1a or 1b or
- 1c > 1) deficits
Show all 10Show fewer
- known or expected inability to maintain follow-up through the study intervention and post- assessment
- contraindications to MRI
- contraindications to TMS
- known history of uncontrolled seizure disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Laboratory for Translational Neurorecovery, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital
Boston, Massachusetts, 02114
Caroline Lambert, 617-726-1311, celambert@mgh.harvard.edu
Julie DiCarlo, 617-726-1311, jdicarlo2@mgh.harvard.edu
About this study
Official title: Defining the Neurological Substrates of Proximal Upper Extremity Motor Control and Recovery After Stroke
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. This project seeks to generate fundamental knowledge about brain pathways that allow people to move their arm after stroke and how these pathways change with rehabilitation; we expect this knowledge to translate to new therapies to reduce stroke-related disability.
We plan to enroll N = 50 patients with moderate to severe difficulty moving their arm after ischemic or hemorrhage stroke during the subacute period (3 to 6 months post stroke) into either 30 hours over 6 weeks of Arm Basis Training (a protocolized form of occupational therapy targeting motor control) or usual care. We will perform kinematic motor assessments, neuroimaging, and neurophysiology before and after therapy in order to test the hypothesis that intensive, target training improves arm motor control and induces corresponding anatomical and physiological changes of associated brain pathways.
Read the detailed description
Strokes commonly damage motor pathways in the brain which leads to "hemiparesis", the collective term given to the syndrome of motor dysfunction after stroke. Upper extremity hemiparesis is comprised of both loss of abilities (negative signs- weakness and loss of dexterity or fractionated motor control) and intrusion of abnormal movements (positive signs- spasticity, abnormal resting postures, and synergies).
Recent work from our group and others shows that components of motor hemiparesis are dissociable: they can be separated and each map onto different and specific brain pathways. In this proposal, we focus on one specific component of post-stroke hemiparesis: proximal upper extremity motor control. Proximal upper extremity motor control can be measured as the ability to individuate and coordinate shoulder and elbow movements. We ask (i) where does proximal upper extremity motor control localize in the post-stroke brain? (ii) can we improve motor control with a specific form of targeted, high-dose, high-intensity therapy? And (iii) does therapy lead to corresponding changes in anatomy and physiology of brain pathways? Our central hypothesis is that intensive, targeted training improves proximal upper extremity motor control and induces corresponding anatomical and physiological changes of the corticospinal tract. To test this hypothesis, we will conduct three specific aims: (1) Determine baseline relationships between the corticospinal tract and proximal upper extremity motor control, (2) Define changes in proximal upper extremity motor control induced by targeted rehabilitation training, and (3) Define changes in corticospinal tract anatomy and physiology induced by targeted rehabilitation training. We leverage a clinical trial design of N = 50 patients with moderate-severe hemiparesis randomized to two groups: Arm Basis Training (a protocolized form of occupational therapy targeting motor control) versus usual care. Before and after six weeks of therapy, all patients will undergo kinematic assessment of motor control, diffusion magnetic resonance imaging to assess corticospinal tract axon density, and transcranial magnetic stimulation to assess corticospinal excitability. Dr. Lin, an acute care neurologist with neurorehabilitation and neuroscience training and the Director of the MGH Neurorecovery Clinic, will lead the project and bring together a world-class team of investigators and consultants, supported by the rich and multidisciplinary environment at Massachusetts General Hospital, Harvard Medical School, and collaborating institutions. This project is a mechanistic and hypothesis-driven investigation of the neuroanatomic and neurophysiologic signatures of a specific component of hemiparesis, proximal upper extremity motor control, and its response to targeted rehabilitation. The unique integration of kinematics, neuroanatomy, and neurophysiology in patients after stroke will transform stroke rehabilitation with a precision approach that targets brain structure and function.
- Conditions
- Stroke Rehabilitation, Stroke, Neurorecovery
- Being tested
- Arm Basis Training
- Keywords
- stroke rehabilitation, motor control, neurorecovery, upper limb kinematics, corticospinal tract
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm Basis TrainingBehavioural
This program is a systematic training regimen specifically designed to improve proximal motor control for patients with severe upper extremity hemiparesis. The core principles of the Arm Basis Training Program focus on rebuilding the fundamental capacity for specific and selective motor control before progressing to more complex motor patterns.
| Study group | Role | What they receive |
|---|---|---|
| Arm Basis Training | Experimental | This program is a systematic training regimen specifically designed to improve proximal motor control for patients with severe upper extremity hemiparesis. The core principles of the Arm Basis Training Program focus on rebuilding the fundamental capacity for specific and selective motor control before progressing to more complex motor patterns. Receives: Behavioral: Arm Basis Training |
| Usual Care Occupational Therapy | No intervention | Usual care occupational therapy. Participants will be asked to keep logs of the therapy they receive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kinematic Measure of Upper Extremity Motor Control
Kinematic measures of Upper Extremity Motor Control include joint individuation index (a measure of how well joints can move independently of other joints) and shoulder-elbow coordination (a measure of how normal a point-to-point planar reaching movement is)
Measured: Pre- and post- 6 weeks of therapy
Change in Corticospinal Tract Axon Density on MRI
High-resolution diffusion MR neuroimaging will be performed, from which corticospinal tract axon density will be calculated
Measured: Pre- and post- 6 weeks of therapy
Change in Corticospinal Tract Neurophysiology
The primary neurophysiologic measure of interest will be MEP presence or absence at proximal upper extremity muscles. If MEP positive, secondary measures of corticospinal excitability will be the MEP recruitment curve slope as well as MEP amplitude (at 100% MSO).
Measured: Pre- and post- six weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start7 Oct 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mechanistic randomized controlled trial of arm basis training (a protocolized form of occupational therapy targeting proximal upper extremity motor control) versus usual care occupational therapy
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Lin, Massachusetts General Hospital
- Investigators
- David J Lin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998485
- Sponsor's protocol ID
- 2025P000641
- Other IDs
- R01NS142153
- Acronym
- SPARk
- Status last verified
- Mar 2026
- First submitted
- 22 May 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. We will release raw behavior, imaging, and physiology data sets with relevant de-identified data to the database \~12 months after we have finished a portion of the project with enough sample size for publication. We will give database access to investigators who contact us about specific projects or analyses and/or are willing to enter into the same data sharing, authorship, and human subject data protection protocols that binds our multi-institutional collaboration, and agree to work closely with us to ensure that these complex data are analyzed with complete understanding of the experimental conditions under which they were collected. 2. We will also release annotated, preprocessed datasets from this grant that form the basis for published manuscripts two years after their initial (online) publication date. We will make data available to individuals who agree to a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Neurological Substrates of Proximal Upper Extremity Motor Control and Recovery After Stroke
- ClinicalTrials.gov ID
- NCT06998485
- Acronym / sponsor ID
- SPARk / 2025P000641
- Conditions
- Stroke Rehabilitation, Stroke, Neurorecovery
- Keywords
- stroke rehabilitation, motor control, neurorecovery, upper limb kinematics, corticospinal tract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 31 May 2025 (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.
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. This project seeks to generate fundamental knowledge about brain pathways that allow people to move their arm after stroke and how these pathways change with rehabilitation; we expect this knowledge to translate to new therapies to reduce stroke-related disability.
We plan to enroll N = 50 patients with moderate to severe difficulty moving their arm after ischemic or hemorrhage stroke during the subacute period (3 to 6 months post stroke) into either 30 hours over 6 weeks of Arm Basis Training (a protocolized form of occupational therapy targeting motor control) or usual care. We will perform kinematic motor assessments, neuroimaging, and neurophysiology before and after therapy in order to test the hypothesis that intensive, target training improves arm motor control and induces corresponding anatomical and physiological changes of associated brain pathways.
Detailed description
Strokes commonly damage motor pathways in the brain which leads to "hemiparesis", the collective term given to the syndrome of motor dysfunction after stroke. Upper extremity hemiparesis is comprised of both loss of abilities (negative signs- weakness and loss of dexterity or fractionated motor control) and intrusion of abnormal movements (positive signs- spasticity, abnormal resting postures, and synergies).
Recent work from our group and others shows that components of motor hemiparesis are dissociable: they can be separated and each map onto different and specific brain pathways. In this proposal, we focus on one specific component of post-stroke hemiparesis: proximal upper extremity motor control. Proximal upper extremity motor control can be measured as the ability to individuate and coordinate shoulder and elbow movements. We ask (i) where does proximal upper extremity motor control localize in the post-stroke brain? (ii) can we improve motor control with a specific form of targeted, high-dose, high-intensity therapy? And (iii) does therapy lead to corresponding changes in anatomy and physiology of brain pathways? Our central hypothesis is that intensive, targeted training improves proximal upper extremity motor control and induces corresponding anatomical and physiological changes of the corticospinal tract. To test this hypothesis, we will conduct three specific aims: (1) Determine baseline relationships between the corticospinal tract and proximal upper extremity motor control, (2) Define changes in proximal upper extremity motor control induced by targeted rehabilitation training, and (3) Define changes in corticospinal tract anatomy and physiology induced by targeted rehabilitation training. We leverage a clinical trial design of N = 50 patients with moderate-severe hemiparesis randomized to two groups: Arm Basis Training (a protocolized form of occupational therapy targeting motor control) versus usual care. Before and after six weeks of therapy, all patients will undergo kinematic assessment of motor control, diffusion magnetic resonance imaging to assess corticospinal tract axon density, and transcranial magnetic stimulation to assess corticospinal excitability. Dr. Lin, an acute care neurologist with neurorehabilitation and neuroscience training and the Director of the MGH Neurorecovery Clinic, will lead the project and bring together a world-class team of investigators and consultants, supported by the rich and multidisciplinary environment at Massachusetts General Hospital, Harvard Medical School, and collaborating institutions. This project is a mechanistic and hypothesis-driven investigation of the neuroanatomic and neurophysiologic signatures of a specific component of hemiparesis, proximal upper extremity motor control, and its response to targeted rehabilitation. The unique integration of kinematics, neuroanatomy, and neurophysiology in patients after stroke will transform stroke rehabilitation with a precision approach that targets brain structure and function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mechanistic randomized controlled trial of arm basis training (a protocolized form of occupational therapy targeting proximal upper extremity motor control) versus usual care occupational therapy
| Arm | Type | Receives |
|---|---|---|
| Arm Basis Training | Experimental | Behavioral: Arm Basis TrainingThis program is a systematic training regimen specifically designed to improve proximal motor control for patients with severe upper extremity hemiparesis. The core principles of the Arm Basis Training Program focus on rebuilding the fundamental capacity for specific and selective motor control before progressing to more complex motor patterns. |
| Usual Care Occupational Therapy | No intervention | –Usual care occupational therapy. Participants will be asked to keep logs of the therapy they receive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first time unilateral ischemic or hemorrhagic stroke occurring within the 3-6 months
- upper extremity motor impairment as measured by the Upper Extremity Fugl-Meyer Assessment (UE-FMA) Score <= 44
- ability to participate in a 6-week intensive upper extremity intervention in English as determined by a licensed occupational therapist.
Key exclusion criteria (10 listed)
- bilateral stroke
- unstable medical status affecting functional status
- pre-stroke upper extremity injury or conditions that limited use
- visual or auditory impairment limiting ability to participate in study procedures
- significant aphasia (NIHSS sub-item 9 > 1) or cognitive (NIHSS 1a or 1b or
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 Basis TrainingThis program is a systematic training regimen specifically designed to improve proximal motor control for patients with severe upper extremity hemiparesis. The core principles of the Arm Basis Training Program focus on rebuilding the fundamental capacity for specific and selective motor control before progressing to more complex motor patterns. | Behavioural | Arm Basis Training |
Primary outcome
Change in Kinematic Measure of Upper Extremity Motor Control
Time frame: Pre- and post- 6 weeks of therapy
Kinematic measures of Upper Extremity Motor Control include joint individuation index (a measure of how well joints can move independently of other joints) and shoulder-elbow coordination (a measure of how normal a point-to-point planar reaching movement is)
Change in Corticospinal Tract Axon Density on MRI
Time frame: Pre- and post- 6 weeks of therapy
High-resolution diffusion MR neuroimaging will be performed, from which corticospinal tract axon density will be calculated
Change in Corticospinal Tract Neurophysiology
Time frame: Pre- and post- six weeks of therapy
The primary neurophysiologic measure of interest will be MEP presence or absence at proximal upper extremity muscles. If MEP positive, secondary measures of corticospinal excitability will be the MEP recruitment curve slope as well as MEP amplitude (at 100% MSO).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes. 1. We will release raw behavior, imaging, and physiology data sets with relevant de-identified data to the database ~12 months after we have finished a portion of the project with enough sample size for publication. We will give database access to investigators who contact us about specific projects or analyses and/or are willing to enter into the same data sharing, authorship, and human subject data protection protocols that binds our multi-institutional collaboration, and agree to work closely with us to ensure that these complex data are analyzed with complete understanding of the experimental conditions under which they were collected. 2. We will also release annotated, preprocessed datasets from this grant that form the basis for published manuscripts two years after their initial (online) publication date. We will make data available to individuals who agree to a data-sharing agreement.
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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.
David J Lin, MD principal investigator
Massachusetts General Hospital
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 Basis Training in people with Stroke Rehabilitation and Stroke, run by Massachusetts General Hospital 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 10 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Lambert, BA (617-726-1311, celambert@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kinematic Measure of Upper Extremity Motor Control (time frame: Pre- and post- 6 weeks of therapy). 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 11 Mar 2026.