Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates a partially self-supervised constraint-induced movement therapy (sCIMT) approach for adults with arm and hand weakness after stroke. Participants will perform a therapy routine five days a week for two weeks, with a mitt worn on the stronger hand during selected activities to encourage use of the affected limb. The study will assess functional use of the affected arm, participant-perceived usefulness and feasibility, and impact on quality of life. Outcomes include objective motor assessments and self-reported measures collected before and after the program. The trial is led by Ohio State University in Columbus, with no listed collaborators beyond the lead sponsor.

Why it matters

Who can join: the full rules

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).

Where it's running

• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Peyton Miller
• Email: peyton.miller@osumc.edu
• Phone: 380-283-5825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.