Recruiting

sCIMT

Sponsor:

Ohio State University

Code:

NCT07723300

Conditions

Stroke

Stroke (CVA) or TIA

Cerebral Vascular Accident (CVA)/Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Self-Supervised Constraint-Induced Movement Therapy (sCIMT)

Study Details

Brief summary:

The goal of this clinical trial is to learn how a partially self-supervised constraint-induced movement therapy (sCIMT) program in adults with arm and hand weakness will work after stroke. This study will look at whether the program can help people improve the use of their arm and hand after a stroke while requiring less time with a therapist. The main questions it aims to answer are:

  • Does the sCIMT program help people use their affected arm and hand better - after a stroke?
  • Do participants feel that the sCIMT program is useful, easy to follow, and a good fit for their recovery needs?
  • Does taking part in the sCIMT program improve participants' quality of life and daily well-being?

Participants will:

  • Take part in a therapy program 5x/week for 2 weeks. The program is designed to help improve the use of the arm and hand affected by stroke.
  • Wear a mitt on the stronger hand during certain practice activities to encourage use of the weaker hand.
  • Complete surveys and tests before and after the program to measure arm and hand use, experiences with the program, and quality of life.

Conditions

Stroke

Stroke (CVA) or TIA

Cerebral Vascular Accident (CVA)/Stroke

Study ID

NCT07723300

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Sustained a first-time ischemic or hemorrhagic stroke ≥2 weeks prior to study enrollment
  • Age ≥18 and ≤85
  • Moderate UE hemiparesis as defined by a score ≥13 and ≤47 on the modified UE section of the Fugl-Meyer Assessment (60-point scale with no reflex testing)
  • Ability to actively extend impaired wrist ≥10 degrees
  • UE strength and active range of motion within functional limits on the non-hemiparetic side
  • Ability to follow two-step commands (visual or verbal) as determined by the clinical investigator
  • Nonuse of the more impaired UE as evidenced by an average score ≤2.5 on the Motor Activity Log Amount of Use Scale.

Exclusion Criteria:

  • Excessive pain in the affected shoulder, arm, or hand as measured by a score ≥6 on a 10-point visual analogue scale
  • Unable to passively reach neutral position for wrist extension and forearm supination
  • Excessive spasticity in the affected wrist or finger flexors/extensors and elbow flexors, as defined as a score of >2 on the Modified Ashworth Scale (MAS)
  • Inability to actively participate in regular therapy sessions (e.g., due to medical complexity, insufficient endurance, transportation, etc.) as determined by participant or by clinical judgement of the evaluating therapist
  • Receiving occupational therapy services for the hemiparetic UE during the two-week intervention window (including after pre-assessment and before post-assessment)
  • Received focal anti-spasticity drug injection (e.g., Botox) to any muscles of the impaired UE within the past 1 month (or plan to at some point during study enrollment)
  • Comorbid diagnosis in addition to stroke (e.g., dementia, peripheral neuropathy) that in the opinion of the investigator could impact study results
  • Presence of moderate to severe unilateral spatial neglect as indicated by clinical observation or failure on a standardized screening tool (e.g., Line Bisection Test or Bells Test).

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self-Supervised Constraint-Induced Movement Therapy

Participants will receive self-supervised constraint-induced movement therapy (sCIMT) to improve upper extremity function following stroke. The intervention consists of up to 30 hours of rehabilitation delivered over 2 weeks (3-hour sessions, up to 5 sessions per week). During each session, participants alternate between brief periods of one-to-one therapist-guided training and self-supervised task practice, with approximately one-third of treatment time provided individually by a therapist and two-thirds completed independently. Treatment activities include task-oriented functional and non-functional upper extremity exercises designed to promote motor recovery and use of the affected arm.

Interventions

Self-Supervised Constraint-Induced Movement Therapy (sCIMT)

Self-supervised constraint-induced movement therapy (sCIMT) is an upper extremity rehabilitation intervention for individuals with stroke. Participants receive up to 30 hours of rehabilitation over 2 weeks (3-hour sessions, up to 5 sessions per week). The intervention combines therapist-guided training with self-supervised task practice, with approximately one-third of treatment time delivered individually by a therapist and two-thirds completed independently. Treatment activities include task-oriented functional and non-functional upper extremity exercises designed to promote use of the affected arm, improve motor function, and support functional recovery.

Primary outcome measure

  • Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention [ Time Frame: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program) ]
  • Implementation of sCIMT (AIM, FIM, IAM Score) [ Time Frame: Post-intervention (within 1 week of completing the 2-week sCIMT program) ]

Central Contacts and Locations

Central contacts

Peyton Miller

380-283-5825peyton.miller@osumc.edu

Lauren Wengerd

lauren.wengerd@osumc.edu

Locations

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Stroke
  • Constraint-Induced Movement Therapy
  • Rehabilitation
  • CIMT
  • Upper Extremity Rehabilitation
  • Neurorehabilitation
  • Post-Stroke Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-08-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.