- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07717528
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Zobia Naseem, Phd
- Telefonní číslo: 03321963584
- E-mail: zobia.naeem@riphah.edu.pk
Studijní záloha kontaktů
- Jméno: Imran Amjad, Phd
- Telefonní číslo: 03324390125
- E-mail: mailto:imran.amjad@riphah.edu.pk
Studijní místa
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Kpk
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Peshawar, Kpk, Pákistán, 25000
- Peshawar Sports Complex
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Kontakt:
- Zobia Naseem, Ms SPT
- Telefonní číslo: 03321963584
- E-mail: zobia.naeem@riphah.edu.pk
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Dílčí vyšetřovatel:
- Nigah e Zahra Syed, MS SPT*
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Gait Performance Assessed Using the Timed Tandem Gait (TTG) Test
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Post-Concussion Symptom Severity Assessed Using the Sport Concussion Office Assessment Tool 6 (SCOAT6) Symptom Scale
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Zobia Naseem, PhD, Riphah International University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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