Substrates for Post-Stroke Arm Rehabilitation

NCT06998485 | Recruiting

• 2 other identifiers: 2025P000641R01NS142153
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke Rehabilitation; Stroke; Neurorecovery

Keywords

stroke rehabilitation; motor control; neurorecovery; upper limb kinematics; corticospinal tract

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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).

  Pre- and post- six weeks of therapy

Study Arms (2)

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.

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.

Interventions

Arm Basis Training BEHAVIORAL

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.

Arm Basis Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• c \> 1) deficits
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Laboratory for Translational Neurorecovery, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David J Lin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Lambert, BA

CONTACT

617-726-1311; celambert@mgh.harvard.edu

Julie DiCarlo, MS

CONTACT

617-726-1311; jdicarlo2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Model Details: 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

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: May 2031 -
• Access Criteria: 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.

Locations

US (1)