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Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

24. August 2026 aktualisiert von: Lauren Wengerd, Ohio State University

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

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

12

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Rekrutierung
        • Ohio State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Self-Supervised Constraint-Induced Movement Therapy
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.
Verhalten: 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-oriented functional and non-functional upper extremity exercises designed to promote use of the affected arm, improve motor function, and support functional recovery.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention
Zeitfenster: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
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)
Zeitfenster: Post-intervention (within 1 week of completing the 2-week 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.
Post-intervention (within 1 week of completing the 2-week sCIMT program)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment Rate
Zeitfenster: Through completion of study enrollment, an average of 18 months
Recruitment rate will be defined as the number of enrolled participants per month. (e.g., 2.3 participants per month)
Through completion of study enrollment, an average of 18 months
Participant Retention Rate
Zeitfenster: Through study completion, an average of 18 months
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.
Through study completion, an average of 18 months
Intervention Adherence Rate
Zeitfenster: During Intervention Period (2 weeks)
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.
During Intervention Period (2 weeks)
Change in Health-Related Quality of Life from Baseline to Post-Intervention (EQ-5D-5L)
Zeitfenster: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
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.
Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
Number of Protocol Deviations
Zeitfenster: Through study completion, an average of 18 months
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.
Through study completion, an average of 18 months
Number of Adverse Events
Zeitfenster: From enrollment to the end of treatment (approximately 2-4 weeks total participation window)
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.
From enrollment to the end of treatment (approximately 2-4 weeks total participation window)
Clinician Time per Session
Zeitfenster: During Each Intervention Session (2-week sCIMT program)
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.
During Each Intervention Session (2-week sCIMT program)
Change in Fugl-Meyer Assessment (FMA) from Baseline to Post-Intervention
Zeitfenster: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
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.
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
Zeitfenster: Baseline and post-intervention (within 1 week of completing the 2-week sCIMT program)
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.
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
Zeitfenster: Baseline and post-intervention (within 1 week following completion of the 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.
Baseline and post-intervention (within 1 week following completion of the intervention)
Change in Box and Block Test (BBT) from Baseline to Post-Intervention
Zeitfenster: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
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.
Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Grip/Pinch Strength
Zeitfenster: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
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.
Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Sensory Testing
Zeitfenster: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
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.
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)
Zeitfenster: Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
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.
Baseline and post-intervention (within 1 week of completing 2-week sCIMT program)
Semi-Structured Interviews
Zeitfenster: Post-Intervention (within 1 week of completing the 2-week sCIMT program)
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.
Post-Intervention (within 1 week of completing the 2-week sCIMT program)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper Extremity Movement Repetitions (Video Analysis)
Zeitfenster: During intervention sessions (2-week treatment period)
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.
During intervention sessions (2-week treatment period)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

29. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY20250878

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared because participant-level data were collected solely for the purposes of the current study and participant consent did not include provisions for future sharing of de-identified datasets with external investigators. Study results will be disseminated through aggregate analyses and publications that do not permit identification of individual participants.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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