Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Self-Supervised Constraint-Induced Movement Therapy (sCIMT)
BehavioralSelf-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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Self-Supervised Constraint-Induced Movement TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)2
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.
Time frame
Post-intervention (within 1 week of completing the 2-week sCIMT program)Secondary outcomes
1
Recruitment Rate
Recruitment rate will be defined as the number of enrolled participants per month. (e.g., 2.3 participants per month)
Time frame
Through completion of study enrollment, an average of 18 months2
Participant Retention Rate
Retention rate will be defined as the percentage of enrolled participants who complete the intervention and post-intervention outcome assessments. This measure will assess the feasibility of maintaining participant engagement throughout the self-supervised constraint-induced movement therapy (sCIMT) program.
Time frame
Through study completion, an average of 18 months3
Intervention Adherence Rate
Adherence will be measured as the proportion of intervention sessions (out of 10) completed by each participant during the 2-week intervention period. Session attendance and completion of prescribed therapy hours will be tracked to evaluate protocol feasibility and participant compliance.
Time frame
During Intervention Period (2 weeks)4
Change in Health-Related Quality of Life from Baseline to Post-Intervention (EQ-5D-5L)
The EuroQol-5 Dimension-5 Level (EQ-5D-5L) is a standardized measure of health-related quality of life assessing five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-level scale. Change scores from baseline to post-intervention are used to assess changes in overall health-related quality of life, with higher index values indicating better health status.
Time frame
Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)Other outcomes
1
Upper Extremity Movement Repetitions (Video Analysis)
Upper extremity movement repetitions will be quantified using video recordings of intervention sessions analyzed with Mangold INTERACT software. This exploratory measure will provide an estimate of affected limb use and therapy engagement during self-supervised constraint-induced movement therapy (sCIMT) sessions.
Time frame
During intervention sessions (2-week treatment period)Sponsors and contacts
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Source ClinicalTrials.gov