- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07717528
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zobia Naseem, Phd
- Número de teléfono: 03321963584
- Correo electrónico: zobia.naeem@riphah.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Imran Amjad, Phd
- Número de teléfono: 03324390125
- Correo electrónico: mailto:imran.amjad@riphah.edu.pk
Ubicaciones de estudio
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Kpk
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Peshawar, Kpk, Pakistán, 25000
- Peshawar Sports Complex
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Contacto:
- Zobia Naseem, Ms SPT
- Número de teléfono: 03321963584
- Correo electrónico: zobia.naeem@riphah.edu.pk
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Sub-Investigador:
- Nigah e Zahra Syed, MS SPT*
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Gait Performance Assessed Using the Timed Tandem Gait (TTG) Test
Periodo de tiempo: Baseline (Week 0) and Week 8 (post-intervention)
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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.
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Baseline (Week 0) and Week 8 (post-intervention)
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Balance Performance Assessed Using the Balance Error Scoring System (BESS)
Periodo de tiempo: Baseline (Week 0) and Week 8 (post-intervention)
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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.
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Baseline (Week 0) and Week 8 (post-intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Post-Concussion Symptom Severity Assessed Using the Sport Concussion Office Assessment Tool 6 (SCOAT6) Symptom Scale
Periodo de tiempo: Baseline (Week 0) and Week 8 (post-intervention)
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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.
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Baseline (Week 0) and Week 8 (post-intervention)
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Concussion Severity Classification Assessed Using the Cantu Concussion Grading Scale
Periodo de tiempo: Baseline (Week 0)
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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.
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Baseline (Week 0)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Zobia Naseem, PhD, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Lesiones Cerebrales Traumáticas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Traumatismos craneales, Cerrado
- Heridas No Penetrantes
- Lesiones Cerebrales
- Contusión cerebral
- Síndrome posterior a la conmoción cerebral
Otros números de identificación del estudio
- Nigah e Zahra Syed
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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