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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Ohio State University
Columbus, Ohio, United States
RECRUITINGChange 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)
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)
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 months
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 months
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)
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)
Number of Protocol Deviations
Protocol deviations will be recorded throughout the study and categorized by type and frequency using case report forms. Deviations will include any departures from the planned intervention procedures, assessment schedule, or study protocol.
Time frame: Through study completion, an average of 18 months
Number of Adverse Events
Adverse events will be monitored and documented throughout the study, including severity and potential relationship to the self-supervised constraint-induced movement therapy (sCIMT) intervention. Events will be categorized and summarized to evaluate safety and tolerability of the intervention.
Time frame: From enrollment to the end of treatment (approximately 2-4 weeks total participation window)
Clinician Time per Session
Clinician time required per session will be tracked to estimate personnel burden associated with delivery of the self-supervised constraint-induced movement therapy (sCIMT) protocol. Time spent in direct patient supervision and instruction will be recorded for each session.
Time frame: During Each Intervention Session (2-week sCIMT program)
Change in Fugl-Meyer Assessment (FMA) from Baseline to Post-Intervention
The motor domain of the Fugl-Meyer Assessment (FMA) evaluates upper extremity motor impairment following stroke by assessing voluntary movement, coordination, and movement performed within and out of synergistic patterns. This study uses the motor assessment only and does not include reflex testing.
Time frame: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
Change in 9-Hole Peg Test from Baseline to Post-Intervention
The 9-Hole Peg Test (9HPT) is a standardized measure of upper extremity dexterity that assesses fine motor coordination by timing how long it takes a participant to place and remove nine pegs from a pegboard. Shorter completion times indicate better manual dexterity.
Time frame: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
Change in the Motor Activity Log (MAL) from Baseline to Post-Intervention
The Motor Activity Log (MAL) is a structured interview that assesses how often (Amount of Use) and how well (Quality of Movement) participants use their affected upper extremity to perform activities of daily living in real-world settings. Scores are based on participant self-report, with higher scores indicating more frequent and higher-quality use of the affected arm.
Time frame: Baseline and post-intervention (within 1 week following completion of the intervention)
Change in Box and Block Test (BBT) from Baseline to Post-Intervention
The Box and Block Test (BBT) is a standardized measure of gross manual dexterity. Participants are asked to move as many wooden blocks as possible from one compartment of a box to another within 60 seconds using one hand. The total number of blocks transferred is recorded, with higher scores indicating better manual dexterity.
Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Grip/Pinch Strength
Grip and pinch strength are measures of upper extremity strength assessed using a dynamometer (grip) and pinch gauge (lateral, tip, and palmar pinch). Participants are asked to exert maximal voluntary force, and the highest value from repeated trials is recorded. Higher values indicate greater strength.
Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Sensory Testing
The GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) sensory subtest is a standardized measure of upper extremity somatosensory function. It assesses light touch and pressure sensation in the hand and fingers using standardized stimuli applied to specific dermatomes. Scores reflect the level of sensory impairment, with higher scores indicating better sensory function.
Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Change in Health-Related Quality of Life from Baseline to Post-Intervention (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a standardized questionnaire measuring health-related quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Change scores from baseline to post-intervention are used to assess changes in overall health-related quality of life, with higher scores indicating better health status.
Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Semi-Structured Interviews
Semi-structured interviews and/or focus groups will be conducted to explore participants' perceptions of the sCIMT intervention, including barriers and facilitators to participation, usability, and overall impressions of the protocol. Qualitative data will be analyzed to identify common themes related to implementation and user experience.
Time frame: Post-Intervention (within 1 week of completing the 2-week sCIMT program)
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