- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07717528
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Zobia Naseem, Phd
- Telefonnummer: 03321963584
- E-Mail: zobia.naeem@riphah.edu.pk
Studieren Sie die Kontaktsicherung
- Name: Imran Amjad, Phd
- Telefonnummer: 03324390125
- E-Mail: mailto:imran.amjad@riphah.edu.pk
Studienorte
-
-
Kpk
-
Peshawar, Kpk, Pakistan, 25000
- Peshawar Sports Complex
-
Kontakt:
- Zobia Naseem, Ms SPT
- Telefonnummer: 03321963584
- E-Mail: zobia.naeem@riphah.edu.pk
-
Unterermittler:
- Nigah e Zahra Syed, MS SPT*
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gait Performance Assessed Using the Timed Tandem Gait (TTG) Test
Zeitfenster: 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)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Post-Concussion Symptom Severity Assessed Using the Sport Concussion Office Assessment Tool 6 (SCOAT6) Symptom Scale
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Zobia Naseem, PhD, Riphah International University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Hirnverletzungen, traumatisch
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Kraniozerebrales Trauma
- Trauma, Nervensystem
- Kopfverletzungen, geschlossen
- Wunden, nicht durchdringend
- Hirnverletzungen
- Gehirnerschütterung
- Post-Concussion-Syndrom
Andere Studien-ID-Nummern
- Nigah e Zahra Syed
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Gehirnerschütterung
-
Neuroscience GroupUltraThera Tehcnologies, llcRekrutierung
-
McMaster UniversityNoch keine RekrutierungPost Concussion Syndrom
-
Lahore University of Biological and Applied SciencesNoch keine Rekrutierung
-
Sunnybrook Health Sciences CentreRekrutierungPost Concussion SyndromKanada
-
University of ArizonaZurückgezogenPost Concussion SyndromVereinigte Staaten
-
Collège d'Études OstéopathiquesAbgeschlossenPost Concussion SyndromKanada
-
Cognitive FXAbgeschlossenPost-Konkussives Syndrom | Angststörung nicht anders angegeben | Symptome nach einer Gehirnerschütterung | Post Concussion Syndrom | Post -Concussive -Syndrom, chronischVereinigte Staaten
-
Simon Fraser UniversityBeendetKopfverletzung | Post Concussion SyndromKanada
-
Sport Injury Prevention Research CentreUniversity of ManitobaUnbekanntSchädel-Hirn-Trauma | Rehabilitation | Post-Concussion-Syndrom | Aerobic Übung | Gehirnerschütterung, Gehirn | Physiologische Post-Concussion-StörungKanada
-
University of Wisconsin, MadisonNeuraworx Medical TechnologiesRekrutierungLeichte traumatische Hirnverletzung | Post Concussion SyndromVereinigte Staaten
Klinische Studien zur Vestibular Rehabilitation Program
-
Istanbul Medipol University HospitalAktiv, nicht rekrutierendHemiplegie | Physiotherapie und Rehabilitation | Vestibuläre ÜbungenTürkei (türkiye)
-
Marketa BonaventurovaAktiv, nicht rekrutierendGesund | Vestibuläres Schwannom | Einseitiges VestibulardefizitTschechien
-
Riphah International UniversityAnmeldung auf EinladungVestibularfunktionsstörungPakistan
-
Ain Shams UniversityFayoum UniversityAktiv, nicht rekrutierendZahnextraktion | Sofortiges Zahnimplantat | Extraktionssteckdosen der Klasse II | Ästhetische Zone -ImplantologieÄgypten
-
Assiut UniversityNoch keine Rekrutierung
-
Lauro Gutiérrez CastroAbgeschlossenSubstanzgebrauchsstörungen | Alkoholkonsumstörung | Störung des Drogenkonsums | Emotionale Dysregulation | StressintoleranzMexiko
-
Shanghai 6th People's HospitalRekrutierungBilaterale Vestibulopathie | Bilaterale vestibuläre Hypofunktion | PresbyvestibulopathieChina
-
Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)AbgeschlossenAufmerksamkeitsdefizitstörung mit HyperaktivitätVereinigte Staaten
-
University of TorontoCanadian Institutes of Health Research (CIHR)RekrutierungHerz-Kreislauf-Erkrankungen | Dyslipidämie | Kardiovaskuläre Risikofaktoren | Cholesterin | Schwerwiegendes kardiovaskuläres EreignisKanada
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutierungErziehung | ErziehungsinterventionVereinigte Staaten