Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

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.

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.

Recruitment rate will be defined as the number of enrolled participants per month. (e.g., 2.3 participants per month)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.