TELE-REHABILITATION VERSUS CLINIC-BASED MODIFIED CONSTRAINT-INDUCED MOVEMENT THERAPY FOR UPPER LIMB FUNCTION IN CHRONIC STROKE PATIENTS (TELE-mCIMT)
Stroke commonly results in persistent upper limb impairment that limits functional independence and participation in daily activities. Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based intervention for improving upper limb function after stroke. Tele-rehabilitation has emerged as an alternative method of delivering rehabilitation services, potentially improving accessibility while maintaining treatment effectiveness.
This randomized controlled trial will compare the effectiveness of tele-rehabilitation-based mCIMT with clinic-based mCIMT in individuals with chronic stroke. Sixty-eight eligible participants will be randomly allocated into two groups. The tele-rehabilitation group will receive supervised mCIMT through virtual sessions combined with a structured home exercise program, while the clinic-based group will receive the same intervention in a clinical setting. Both groups will receive treatment three times per week for 6 weeks.
Upper limb function, spasticity, motor performance, and intrinsic motivation will be assessed at baseline and after the 6-week intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), Wolf Motor Function Test (WMFT), and Intrinsic Motivation Inventory (IMI). The study aims to determine whether tele-rehabilitation is as effective as clinic-based mCIMT for improving upper limb function in individuals with chronic stroke.
Visão geral do estudo
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Condições
Descrição detalhada
This study is a single-center, randomized controlled trial designed to compare the effectiveness of tele-rehabilitation-based modified Constraint-Induced Movement Therapy (mCIMT) with clinic-based mCIMT in individuals with chronic stroke. A total of 68 participants meeting the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and randomly allocated into two groups using the sealed envelope method. Outcome assessors will remain blinded to group allocation.
Participants in the tele-rehabilitation group will attend an initial in-person assessment followed by supervised virtual rehabilitation sessions. The intervention will include heat application, self-stretching, active-assisted range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy. Participants will perform functional upper limb activities while wearing a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Participants in the clinic-based group will receive the same rehabilitation components, including heat application, stretching, range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy, delivered face-to-face in the rehabilitation clinic. Treatment sessions will be conducted three times per week for 6 weeks, with home practice using the constraint mitt for 4 hours daily.
Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures will include upper limb motor function assessed using the Upper Extremity Fugl-Meyer Assessment (UEFMA) and spasticity assessed using the Modified Ashworth Scale (MAS). Secondary outcome measures will include the Wolf Motor Function Test (WMFT) and the Intrinsic Motivation Inventory (IMI). The study will evaluate whether tele-rehabilitation-based mCIMT provides comparable or superior improvements in upper limb function, motor performance, spasticity, and motivation compared with clinic-based mCIMT in individuals with chronic stroke.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Montiha Azeem, MSPTN
- Número de telefone: 03479717317
- E-mail: muntahaazeem9@gmail.com
Estude backup de contato
- Nome: Kainat Tariq, MSPTN
- Número de telefone: 03328256500
- E-mail: kainattariq06@gmail.com
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
- Recrutamento
- Shadman Medical Center, Lahore
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Contato:
- Montiha Azeem, MSPTN
- Número de telefone: 03479717317
- E-mail: muntahaazeem9@gmail.com
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Contato:
- Kainat Tariq, MSPT N
- Número de telefone: 03328256500
- E-mail: kainattariq06@gmail.com
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Investigador principal:
- Kainat Tariq, MSPTN
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participant with age from 35 to 75 years
- Both gender
- Patients after 6 month of stroke.
- Participant with flexion and abduction at shoulder minimum 10-15 degree and 5-10 degree at wrist and thumb/digit.
- Participants with access to a smartphone or laptop with internet connectivity and the ability to use it for tele-rehabilitation sessions.
- Participant with modified ashworth scale score of 2 or higher.
- Participants who have internet access and can also engage in video conferences.
Exclusion Criteria:
- Patient with any neurological issues apart from stroke that might impact motor function.
- Patient who is not able to follow the commands or are unable to cooperate.
- Patient with any autoimmune disorder like rheumatoid arthritis that might impact arm function.
- Patient with history of epilepsy. Participant who are involved in any fitness program that can improve upper extremity function.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions consisting of heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
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Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions comprising heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
|
|
Comparador Ativo: group B Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
|
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and continue constraint use for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Upper Extremity Fugl-Meyer Assessment (UEFMA)
Prazo: Baseline and Week 6
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The Upper Extremity Fugl-Meyer Assessment (UEFMA) will be used to evaluate upper limb motor recovery.
Changes in UEFMA scores from baseline to the end of the 6-week intervention will be compared between the tele-rehabilitation and clinic-based modified Constraint-Induced Movement Therapy groups.
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Baseline and Week 6
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kainat Tariq, MSPTN, The University of Lahore, Lahore
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UOL/IREB/25/09/0038
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