- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07915141
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
The Effect of a Physiotherapy Program Developed for the Upper Extremity in Hemiplegic İndividuals on Daily Living aAtivities and Quality of Life.
This study aims to investigate the effects of an upper extremity physiotherapy program combined with home exercises on activities of daily living, quality of life, joint range of motion, and pain in individuals with hemiplegia following stroke.
The study compares two groups: participants receiving supervised physiotherapy in addition to a home exercise program and participants performing a home exercise program only. The intervention includes stretching, range-of-motion exercises, arm ergometer training, progressive strengthening, coordination exercises, and fine motor activities.
The intervention period lasts 10 weeks. Outcomes are assessed using the Barthel Index, Short Form-36 (SF-36), Visual Analog Scale (VAS), goniometric measurements, and sensory assessments.
The study aims to evaluate whether adding supervised physiotherapy to home exercises provides additional benefits for upper extremity rehabilitation following stroke.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gülşen Yıldız, Bachelor of Science - Lisans
- Número de telefone: +90 551 220 29 09
- E-mail: gulsen.997178@gmail.com
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Avrasya Hospital Gaziosmanpaşa and zeytinburnu
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Contato:
- ali emre takkin, MsC
- Número de telefone: +90 507 154 48 87
- E-mail: aliemre.takkin@gmail.com
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Investigador principal:
- Gülşen Yıldız, BSc
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Istanbul, Turquia (Türkiye)
- Avrasya Hospital- Gaziosmanpaşa and Zeytinburnu
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Contato:
- Ali Emre Takkin, MsC
- Número de telefone: +90 507 154 48 87
- E-mail: aliemre.takkin@gmail.com
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Investigador principal:
- Gülşen Yıldız, Bsc
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of stroke.
- Age greater than 30 and less than 65 years.
- Time since stroke between 1 and 5 years.
- Voluntary participation in the study and treatment.
- Upper extremity Brunnstrom recovery stage 2 or 3.
- Ability to understand and perform the prescribed exercise program.
Exclusion Criteria:
- Unwillingness to continue participation in the study or treatment.
- Irregular attendance at scheduled treatment sessions.
- Upper extremity contracture severe enough to prevent exercise performance or range of motion assessment.
- Spasticity severe enough to prevent safe and effective upper extremity exercise performance.
- Failure to perform the prescribed home exercises regularly.
- Development of an additional disease or medical condition affecting upper extremity function during the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Physiotherapy and Home Exercise Group
Participants in this group receive supervised upper extremity physiotherapy twice a week for 45 minutes over 10 weeks, in addition to a home exercise program. The physiotherapy program includes stretching, passive and active-assisted range-of-motion exercises, arm ergometer training, progressive resistance exercises using Theraband and dumbbells, coordination exercises, and fine motor activities. The home exercise program is performed five days per week, twice daily for 30 minutes per session. |
Participants in the intervention group receive a 10-week rehabilitation program consisting of supervised upper extremity physiotherapy twice weekly for 45 minutes per session and a structured home exercise program on three non-treatment days per week. The home exercise program is identical in content to that of the control group and includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination training, and fine motor activities. Home exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. Supervised physiotherapy includes stretching, passive, active-assisted and active range-of-motion exercises, wand exercises, arm ergometer training, progressive strengthening using Theraband and 0.5 kg dumbbells, coordination exercises, and fine motor activities. Participants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group. |
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Comparador Ativo: Home Exercise Group
physiotherapy sessions. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. Exercises are performed five days per week, twice daily for 30 minutes per session, with 10 repetitions of each exercise. |
Participants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Barthel Index Score
Prazo: Baseline (Week 1) and post-intervention (Week 10)
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The Barthel Index is used to assess independence in activities of daily living. Total scores range from 0 to 100, with higher scores indicating greater functional independence. Changes in Barthel Index scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in SF-36 Quality of Life Scores
Prazo: Baseline (Week 1) and post-intervention (Week 10)
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The SF-36 is used to assess health-related quality of life across eight domains. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Changes in scores from baseline to the end of the 10-week intervention are compared between the two groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Upper Extremity Range of Motion (ROM)
Prazo: Baseline (Week 1) and post-intervention (Week 10)
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Upper extremity range of motion is assessed using a goniometer. Measurements include shoulder flexion, extension and abduction; elbow flexion and extension; and wrist flexion and extension. Range of motion is recorded in degrees (°), with higher values indicating greater joint mobility. Changes from baseline to Week 10 are compared between the two groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Prazo: Baseline (Week 1) and post-intervention (Week 10)
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Pain intensity is assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in VAS scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Change in Upper Extremity Sensory Function
Prazo: Baseline (Week 1) and post-intervention (Week 10)
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Upper extremity sensory function is assessed using superficial, deep, and cortical sensory tests, including temperature discrimination, sharp-dull discrimination, joint position sense (proprioception), and stereognosis. Changes in sensory function from baseline to Week 10 are evaluated in both groups. |
Baseline (Week 1) and post-intervention (Week 10)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Hande B Besna Göçen, PhD, Istanbul Gelisim University
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STROKE-UE-2025-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data will not be shared.
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