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- Ensaio Clínico NCT02344446
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
Visão geral do estudo
Descrição detalhada
Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:
- Lack of release for Return to Play
- Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale.
Desired sample size: 15 participants.
Skilled treatment: patients will be scheduled for a physical therapy assessment. The PTs will use a prescriptive approach to the assessment of the central nervous system, the cervical spine, and the vestibular system to determine the relative involvement of each system and dysfunction contributing to the patient's physical complaints. This assessment will include the outcome measures that will be obtained pre and post-treatment (Vertigo Symptom Scale (VSS) and the Functional Gait Assessment (FGA). Once the assessment is completed, the PT will initiate treatment, with follow-up visits for PT treatment 1 - 2 times per week. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded. At each PT visit, symptomatic recovery will be tracked using the PCS.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ohio
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North Canton, Ohio, Estados Unidos, 44720
- Walsh University
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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:
Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:
- Lack of release for Return to Play
- Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale
Exclusion Criteria:
- Any one who is not enrolled in the aforementioned RCT
Plano de estudo
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: Skilled Therapy
Differential physical therapy treatment, based on assessment results, with follow-up visits for PT treatment 1 - 2 times per week until patient achieves at least 1 primary outcome.
They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response.
Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician.
Patients may also be prescribed a home exercise program and exercise education.
The precise treatment strategies will be recorded.
|
Active physical therapy treatment
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Symptomatic Recovery
Prazo: Within 6 months of enrollment
|
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
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Within 6 months of enrollment
|
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Return to Play
Prazo: Within 6 months of enrollment
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The treating physician will determine when return to play should be initiated.
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Within 6 months of enrollment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jennifer C Reneker, MSPT, Walsh Unviersity
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- WalshU
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