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Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

24 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

12

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43210
        • Rekrutacyjny
        • Ohio State University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Upper Extremity Movement Repetitions (Video Analysis)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ohio State University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 lipca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

7 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY20250878

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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