Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

Official title

A Novel Approach to Implementing Constraint-Induced Movement Therapy in Stroke Rehabilitation

Overview

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.

Interventions

• 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-o

Primary outcome measures

• Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention [Time frame: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)]
• Implementation of sCIMT (AIM, FIM, IAM Score) [Time frame: Post-intervention (within 1 week of completing the 2-week sCIMT program)]

Secondary outcome measures (12)

• Recruitment Rate [Time frame: Through completion of study enrollment, an average of 18 months]
• Participant Retention Rate [Time frame: Through study completion, an average of 18 months]
• Intervention Adherence Rate [Time frame: During Intervention Period (2 weeks)]
• Change in Health-Related Quality of Life from Baseline to Post-Intervention (EQ-5D-5L) [Time frame: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)]
• Number of Protocol Deviations [Time frame: Through study completion, an average of 18 months]
• Number of Adverse Events [Time frame: From enrollment to the end of treatment (approximately 2-4 weeks total participation window)]
• Clinician Time per Session [Time frame: During Each Intervention Session (2-week sCIMT program)]
• Change in Fugl-Meyer Assessment (FMA) from Baseline to Post-Intervention [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 [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 [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 [Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)]
• Grip/Pinch Strength [Time frame: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Ohio State University — Columbus

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07723300 · STUDY20250878

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗