Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

NCT07723300 | Recruiting

• 1 other identifier: STUDY20250878
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention

  The Action Research Arm Test (ARAT) will be used to assess upper extremity motor function. The ARAT is a standardized performance-based measure consisting of 19 items that evaluate grasp, grip, pinch, and gross arm movement. Total scores range from 0 to 57, with higher scores indicating better upper extremity function. The primary outcome will be the change in ARAT score from baseline (pre-intervention) to post-intervention following completion of the self-supervised constraint-induced movement therapy (sCIMT) program.

  Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)

• Implementation of sCIMT (AIM, FIM, IAM Score)

  The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) comprise a standardized implementation outcomes instrument that evaluates participants' perceptions of an intervention's acceptability, appropriateness, and feasibility. The instrument consists of 12 items (4 items per domain), each rated on a 5-point Likert scale, with higher scores indicating greater perceived acceptability, appropriateness, and feasibility.

  Post-intervention (within 1 week of completing the 2-week sCIMT program)

Secondary Outcomes (15)

• Recruitment Rate

  Through completion of study enrollment, an average of 18 months

• Participant Retention Rate

  Through study completion, an average of 18 months

• Intervention Adherence Rate

  During Intervention Period (2 weeks)

• Change in Health-Related Quality of Life from Baseline to Post-Intervention (EQ-5D-5L)

  Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)

• Number of Protocol Deviations

  Through study completion, an average of 18 months

Other Outcomes (1)

• Upper Extremity Movement Repetitions (Video Analysis)

  During intervention sessions (2-week treatment period)

Study Arms (1)

Self-Supervised Constraint-Induced Movement Therapy

EXPERIMENTAL

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)

Interventions

Self-Supervised Constraint-Induced Movement Therapy (sCIMT) BEHAVIORAL

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.

Self-Supervised Constraint-Induced Movement Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (6)

• Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279.

  PMID: 11387487 BACKGROUND

• Daniel L, Howard W, Braun D, Page SJ. Opinions of constraint-induced movement therapy among therapists in southwestern Ohio. Top Stroke Rehabil. 2012 May-Jun;19(3):268-75. doi: 10.1310/tsr1903-268.

  PMID: 22668681 BACKGROUND

• Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012 Mar-Apr;19(2):104-14. doi: 10.1310/tsr1902-104.

  PMID: 22436358 BACKGROUND

• Thrane G, Friborg O, Anke A, Indredavik B. A meta-analysis of constraint-induced movement therapy after stroke. J Rehabil Med. 2014 Oct;46(9):833-42. doi: 10.2340/16501977-1859.

  PMID: 25182341 BACKGROUND

• Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.

  PMID: 25772900 BACKGROUND

• Taub E, Crago JE, Burgio LD, Groomes TE, Cook EW 3rd, DeLuca SC, Miller NE. An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. J Exp Anal Behav. 1994 Mar;61(2):281-93. doi: 10.1901/jeab.1994.61-281.

  PMID: 8169577 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Peyton Miller

CONTACT

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

Lauren Wengerd

CONTACT

lauren.wengerd@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)