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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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.

Recruiting Locations

Ohio State University
Columbus, Ohio 43210

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.