NCT07717528

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of vestibular rehabilitation in improving gait and balance among post-concussion combat athletes aged 18-25 years. Eligible participants diagnosed with mild traumatic brain injury and persistent post-concussion symptoms will be randomly assigned to either a vestibular rehabilitation group or a control group receiving conventional rehabilitation. Gait performance, balance, post-concussion symptom severity, and concussion severity will be assessed using the Timed Tandem Gait (TTG) Test, Balance Error Scoring System (BESS), Sport Concussion Office Assessment Tool 6 (SCOAT6), and Cantu Concussion Grading Scale. Outcome measures will be evaluated at baseline and after the 8-week intervention to determine the effectiveness of vestibular rehabilitation in enhancing functional recovery following concussion.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026May 2027

First Submitted

Initial submission to the registry

June 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 17, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Post-Concussion SyndromeVestibular RehabilitationCombat AthletesSports-Related ConcussionBalanceSCOAT6

Outcome Measures

Primary Outcomes (2)

  • Gait Performance Assessed Using the Timed Tandem Gait (TTG) Test

    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)

    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)

Secondary Outcomes (2)

  • Post-Concussion Symptom Severity Assessed Using the Sport Concussion Office Assessment Tool 6 (SCOAT6) Symptom Scale

    Baseline (Week 0) and Week 8 (post-intervention)

  • Concussion Severity Classification Assessed Using the Cantu Concussion Grading Scale

    Baseline (Week 0)

Study Arms (2)

Vestibular Rehabilitation Group

EXPERIMENTAL

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.

Other: Vestibular Rehabilitation Program

Conventional Rehabilitation Group

ACTIVE COMPARATOR

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.

Other: Conventional Post-Concussion Rehabilitation

Interventions

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.

Vestibular Rehabilitation Group

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.

Conventional Rehabilitation Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peshawar Sports Complex

Peshawar, Kpk, 25000, Pakistan

Location

MeSH Terms

Conditions

Post-Concussion SyndromeBrain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Zobia Naseem, PhD

    Riphah International University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either the vestibular rehabilitation group or the control group. Outcomes will be assessed at baseline and after the 8-week intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 21, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations