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Self-Supervised Constraint-Induced Movement Therapy for Stroke Recovery

24 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

12

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • Ohio State University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Action Research Arm Test (ARAT) Score from Baseline to Post-Intervention
Prazo: 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)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Recruitment Rate
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Upper Extremity Movement Repetitions (Video Analysis)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ohio State University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de julho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY20250878

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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