- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07717528
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized controlled trial aims to investigate the effect of vestibular rehabilitation on gait and balance in post-concussion combat athletes. Combat sport athletes, including those participating in boxing, mixed martial arts (MMA), taekwondo, judo, and similar disciplines, are at a heightened risk of sustaining concussions due to repetitive head impacts, rapid directional changes, and falls inherent to their sports. Although most athletes recover within a few weeks, a substantial proportion continue to experience persistent vestibular symptoms such as dizziness, postural instability, impaired gait, and balance deficits, which may adversely affect athletic performance, delay return to sport, and increase the risk of recurrent injury.
Despite growing evidence supporting vestibular rehabilitation in the general post-concussion population, there remains a paucity of sport-specific research focusing on combat athletes, whose functional demands and rehabilitation requirements differ considerably from those of non-athletic populations.
This study will recruit combat athletes aged 18-25 years with at least two years of training experience who have been diagnosed with mild traumatic brain injury within the previous six months and continue to exhibit post-concussion symptoms affecting gait and balance. Eligible participants who have been medically cleared by a physician or neurologist will undergo baseline assessments using the Cantu Concussion Grading Scale and the Sport Concussion Office Assessment Tool 6 (SCOAT6), followed by standardized evaluations of gait and balance.
Participants will then be randomly allocated to either the vestibular rehabilitation group or the control group. The intervention group will receive a structured vestibular rehabilitation program designed to improve vestibulo-ocular function, gaze stabilization, postural control, and balance, while the control group will receive conventional rehabilitation. Outcome measures will be reassessed at Week 8 using the same standardized assessment procedures to determine the effectiveness of the intervention.
It is hypothesized that vestibular rehabilitation will result in significant improvements in gait performance, balance, and post-concussion symptom severity among post-concussion combat athletes.
The findings of this study are expected to provide evidence for the development of targeted, sport-specific rehabilitation protocols, facilitate safer and more efficient return-to-play decisions, reduce the risk of recurrent injury, and contribute to the advancement of concussion management strategies in sports physiotherapy and neurorehabilitation.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Zobia Naseem, Phd
- Número de telefone: 03321963584
- E-mail: zobia.naeem@riphah.edu.pk
Estude backup de contato
- Nome: Imran Amjad, Phd
- Número de telefone: 03324390125
- E-mail: mailto:imran.amjad@riphah.edu.pk
Locais de estudo
-
-
Kpk
-
Peshawar, Kpk, Paquistão, 25000
- Peshawar Sports Complex
-
Contato:
- Zobia Naseem, Ms SPT
- Número de telefone: 03321963584
- E-mail: zobia.naeem@riphah.edu.pk
-
Subinvestigador:
- Nigah e Zahra Syed, MS SPT*
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participants falling in this category would be recruited into the study.
- Age 18-30 years.
- Combat sport athletes (e.g, boxing, MMA, karate) with at least 2 years of training experience.
- Experiencing post-concussion symptoms affecting gait, balance, or coordination
- Willing and able to provide informed consent
Exclusion Criteria:
- Participants fall in this category would be excluded of the study.
- History of moderate to severe TBI or repeated concussions (>3 cantu scale)
- Preexisting vestibular or neurological disorders unrelated to concussion (e.g., Meniere's disease, multiple sclerosis).
- Current musculoskeletal injuries affecting gait or balance.
- Visual or auditory impairments that interfere with assessments.
- Use of medications that influence balance or coordination (e.g., sedatives, muscle relaxants).
- Unwillingness or inability to participate in the full duration of the rehabilitation protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Vestibular Rehabilitation Group
Participants assigned to this group will receive a structured vestibular rehabilitation program for 8 weeks designed to improve post-concussion vestibular dysfunction.
The program includes vestibulo-ocular reflex (VOR) exercises, gaze stabilization exercises, habituation exercises, balance retraining, postural control exercises, and gait training delivered under the supervision of a physiotherapist in accordance with the study protocol.
|
Participants will receive a structured vestibular rehabilitation program consisting of vestibulo-ocular reflex (VOR) exercises, gaze stabilization exercises, habituation exercises, balance retraining, postural control exercises, and gait training.
The intervention will be supervised by a physiotherapist and delivered over 8 weeks according to the study protocol.
|
|
Comparador Ativo: Conventional Rehabilitation Group
Participants assigned to this group will receive conventional post-concussion rehabilitation for 8 weeks, consisting of standard clinical management, education regarding symptom management, symptom-limited activity, graded aerobic exercise, strengthening and conditioning exercises, sport-specific training, and a staged return-to-play progression.
Targeted vestibular rehabilitation exercises will not be provided.
|
Participants will receive conventional post-concussion rehabilitation consisting of education regarding symptom management, symptom-limited activity, graded aerobic exercise, strengthening and conditioning exercises, sport-specific training, and a staged return-to-play progression over 8 weeks.
Targeted vestibular rehabilitation exercises will not be included.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gait Performance Assessed Using the Timed Tandem Gait (TTG) Test
Prazo: Baseline (Week 0) and Week 8 (post-intervention)
|
Change in gait performance measured by the Timed Tandem Gait (TTG) Test.
The outcome will be reported as the average time (seconds) required to complete the test.
Lower completion time indicates better gait performance.
|
Baseline (Week 0) and Week 8 (post-intervention)
|
|
Balance Performance Assessed Using the Balance Error Scoring System (BESS)
Prazo: Baseline (Week 0) and Week 8 (post-intervention)
|
Change in balance performance measured using the Balance Error Scoring System (BESS).
The outcome will be reported as the total number of balance errors during standardized balance tasks.
Lower scores indicate better balance performance.
|
Baseline (Week 0) and Week 8 (post-intervention)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Post-Concussion Symptom Severity Assessed Using the Sport Concussion Office Assessment Tool 6 (SCOAT6) Symptom Scale
Prazo: Baseline (Week 0) and Week 8 (post-intervention)
|
Change in post-concussion symptom severity measured using the symptom scale component of the Sport Concussion Office Assessment Tool 6 (SCOAT6).
The symptom scale includes 22 symptoms, each rated from 0 (none) to 6 (severe), resulting in a total score ranging from 0 to 132.
Higher scores indicate greater post-concussion symptom severity.
|
Baseline (Week 0) and Week 8 (post-intervention)
|
|
Concussion Severity Classification Assessed Using the Cantu Concussion Grading Scale
Prazo: Baseline (Week 0)
|
Concussion severity will be assessed using the Cantu Concussion Grading Scale, which classifies concussion into Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe).
The scale ranges from Grade 1 to Grade 3, with higher grades indicating greater concussion severity.
Participants will be assessed at baseline for study characterization and eligibility.
|
Baseline (Week 0)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Zobia Naseem, PhD, Riphah International 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
- Nigah e Zahra Syed
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .
Ensaios clínicos em Vestibular Rehabilitation Program
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... e outros colaboradoresRecrutamentoCOVID-19 | Doença grave | Fraqueza Adquirida na UTI | Aptidão cardiorespiratória | FOTOSEstados Unidos
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalDesconhecido
-
Cefaly TechnologyConcluído
-
Universiti Sains MalaysiaConcluídoPlaca dentária | Comportamento | Saúde Bucal | Atitude | ConhecimentoMalásia
-
NYU Langone HealthNational Institute on Aging (NIA)Concluído
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanRecrutamentoDoença Renal Crônica | Diabetes (DM) | Obesidade e Sobrepeso | Osteoartrite do joelhoTaiwan
-
Palo Alto Veterans Institute for ResearchStanford University; Meru Health, Inc.ConcluídoDepressão | Sintomas DepressivosEstados Unidos
-
USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis ObispoConcluídoConsumo de frutas e vegetais | Nutrição infantil | Escolha de comida saudável | Preparação de Alimentos SaudáveisEstados Unidos
-
NYU Langone HealthConcluído
-
University of CalgaryNeursantys IncAinda não está recrutandoEnxaqueca vestibularCanadá