Recruiting

Arm Basis Training

Sponsor:

Massachusetts General Hospital

Code:

NCT06998485

Conditions

Stroke Rehabilitation

Stroke

Neurorecovery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arm Basis Training

Study Details

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

Study ID

NCT06998485

Start date

Oct 7, 2025

Status verified date

Mar, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm Basis Training

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.

no intervention: Usual Care Occupational Therapy

Usual care occupational therapy. Participants will be asked to keep logs of the therapy they receive.

Interventions

Arm Basis Training

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.

Primary outcome measure

  • Change in Kinematic Measure of Upper Extremity Motor Control [ Time Frame: Pre- and post- 6 weeks of therapy ]
  • Change in Corticospinal Tract Axon Density on MRI [ Time Frame: Pre- and post- 6 weeks of therapy ]
  • Change in Corticospinal Tract Neurophysiology [ Time Frame: Pre- and post- six weeks of therapy ]

Central Contacts and Locations

Central contacts

Caroline Lambert, BA

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

Julie DiCarlo, MS

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

Locations

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Caroline Lambert

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

Julie DiCarlo

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-11.