NCT07401706

Brief Summary

This randomized controlled trial with a parallel design was conducted over six months at Ghurki Trust Teaching Hospital to compare the effects of Vestibular Rehabilitation and Routine Physical Therapy on stability, kinesiophobia, and return to sports in athletes with post-concussion syndrome. A total of 34 participants aged 12 to 30 years were enrolled based on specific diagnostic criteria. Non probability convenient sampling was used, followed by random allocation into experimental and control groups through computer generated sequencing and sealed envelope concealment. Single blinding was done, with participants unaware of their assigned intervention. The experimental group received a Vestibular Rehabilitation program consisting of balance training, habituation exercises, and gaze stabilization, while the control group underwent Routine Physical Therapy involving ankle strategies and elliptical training. Both interventions were administered for 30 minutes, three times per week, over four weeks. Outcomes were measured pre- and post-intervention using validated tools: the Balance Error Scoring System (BESS) for postural stability, the Urdu version of the Tampa Scale of Kinesiophobia (TSK), and the Injury Psychological Readiness to Return to Sport Scale (I-PRRS). Data analysis was performed using SPSS version 26, employing appropriate parametric or non-parametric tests based on normality, with significance set at p \< 0.05. Ethical approval was obtained, informed consent was secured, and all procedures adhered to established ethical standards.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

TAMPABESSIPRRSRPTAthletesPost concussion syndromevestibular rehabilitationstabilitykinesiophobiareturn to sports

Outcome Measures

Primary Outcomes (3)

  • Kinesiophobia

    For kinesiophobia the Urdu version of Tampa scale was used to asses athletes. The Urdu version of the TSK is considered to be a valid and reliable tool for assessing kinesiophobia. 1. = strongly disagree 2. = disagree 3. = agree 4. = strongly agree Tampa Scale for Kinesiophobia (TSK) The TSK is a self report questionnaire used to measure fear of movement. It contains 17 items, each scored on a 4-point Likert scale: Total score range: 17 to 68 Reverse scored items: 4, 8, 12, 16 (For these items: 1↔4, 2↔3)

    4 weeks

  • Stability

    The Balance Error Scoring System (BESS) has demonstrated excellent validity and reliability in patients. Test-retest reliability was strong, with ICC values ranging from 0.88 to 0.99 (average 0.90) and Cronbach's alpha between 0.90 and 0.99, indicating high internal consistency.Types of Errors Hands lifted off the iliac crest Opening eyes Step, stumble, or fall Moving hip into \>30° abduction Lifting forefoot or heel Remaining out of the test position for more than 5 seconds The BESS is calculated by adding one error point for each error during the six 20-second tests. Which Foot Was Tested * Left * Right (i.e., the non-dominant foot) Score Card (Number of Errors) Test Condition Firm Surface Foam Surface Double-Leg Stance (feet together) Single-Leg Stance (non-dominant foot) Tandem Stance (non-dominant foot in back) Total Scores: BESS Total:60

    4 weeks

  • Return to sports

    The Injury Psychological Readiness to Return to Sport (I-PRRS) scale was selected as it has undergone translation and validation in Dutch athletes. The instrument demonstrated strong internal consistency (Cronbach's α = 0.94) and excellent test-retest reliability (ICC = 0.89). 0 = no confidence at all, 50 = moderate confidence, 100 = complete confidence. Rate Value My overall confidence to play is \_\_\_\_\_\_\_\_ My confidence to play without pain is \_\_\_\_\_\_\_\_ My confidence to give 100 percent effort is \_\_\_\_\_\_\_\_ My confidence to not concentrate on the injury is \_\_\_\_\_\_\_\_ My confidence in the injured body part to handle the demands of the situation is \_\_\_\_\_\_\_\_ My confidence in my skill level/ability is \_\_\_\_\_\_\_\_ Total: \_\_\_\_\_\_\_\_

    4 weeks

Study Arms (2)

Vestibular Rehabilitation

EXPERIMENTAL

The experimental group received a structured Vestibular Rehabilitation Program that included balance training, habituation exercises, and gaze stabilization exercises. These interventions were designed to improve postural stability, reduce dizziness and motion sensitivity, and enhance visual vestibular interaction. Each session lasted 30 minutes, was conducted three times per week, and continued for a total of four weeks under the supervision of a licensed physical therapist.

Other: Intervention 1

Routine Physical Therapy

ACTIVE COMPARATOR

The control group received Routine Physical Therapy, consisting of ankle strategy exercises to improve postural control through ankle musculature and coordination, along with elliptical training at sub-symptom threshold levels to promote aerobic conditioning. Similar to the experimental group, these sessions were performed for 30 minutes, three times per week, for four weeks, and were supervised by a licensed physical therapist.

Other: Control Arm (Conventional Therapy)

Interventions

Vestibular Rehabilitation includes balance training, habituation exercises, and gaze stabilization/oculomotor training. Balance training is performed 3 times per week, with intensity progressed from static stance to dynamic tasks such as foam beam and head turns. The time is three sets each for 30 seconds, making a total treatment time of 30 minutes. The type of balance training includes static balance (single-leg and tandem) and dynamic balance (foam beam walking with head turns). Habituation exercises were performed three times per week, with intensity of three sets of 100 feet distance covered while gradually increasing complexity from head turns to ball toss. The time is 3 minute activity performed following 1 minute rest, making a total treatment time of 30 minutes. The type of exercise includes VOR habituation such as head turn with ambulation, ball toss up and down while walking, and ball toss side to side while walking. Gaze stabilization/oculomotor training is also performed t

Vestibular Rehabilitation

Routine Physical Therapy consist of ankle strategies and elliptical training. Ankle strategies are performed three times per week with intensity progressed from rocker board to dual-task activities. The time duration is three sets of two minutes with two minutes of rest, resulting in a total treatment time of 30 minutes. The type of exercise involves rocker board movements in anterior/posterior and medial/lateral directions, with or without ball toss or gaze fixation (X1 viewing). Elliptical training is also performed three times per week at mild exertion, starting at level 1 and with asymptomatic threshold. Each session includes a 5-minute warm-up, 20 minutes of training, and a 5-minute cool-down, making the total treatment time 30 minutes. The mode of exercise is submaximal aerobic exercise on an elliptical trainer

Routine Physical Therapy

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12 to 30 years
  • Fulfil the criteria of post concussion syndrome as highlighted by Tator et al.(2016)which requires presence of at least 3 or more persistent symptoms from standardized list
  • Sustained a mTBI in past 3 to 12 weeks
  • Having ongoing symptoms from list in PCSS that started 72 hrs or less after an impact
  • Exhibit objective deficits on standardized baseline examination enabling vestibular and ocular dysfunction

You may not qualify if:

  • Have a chronic infectious disease.
  • Uncontrolled hypertension.
  • Other neurological disorders (not attributed to their primary diagnosis).
  • Cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma.
  • Those on long term use of psychoactive drugs that compromise their ability to perform study activities
  • Those with pacemakers or elevated cardiovascular risk.
  • Ongoing litigation surrounding their injury.
  • Have been diagnosed with a severe brain injury prior to enrollment, or their post concussive symptoms have persisted beyond 12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Concussion SyndromeKinesiophobia

Condition Hierarchy (Ancestors)

Brain ConcussionHead Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Tariq Shafi

    Lahore University of Biological And Applied Health Sciences

    STUDY CHAIR
  • Syeda Farwa Aitbar, DPT

    Lahore College of Physical Therapy

    PRINCIPAL INVESTIGATOR
  • Maheen Mazhar, DPT

    Lahore College of Physical Therapy

    PRINCIPAL INVESTIGATOR
  • Ayesha Naeem Khan, DPT

    Lahore College of Physical Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tariq Shafi, Post graduation

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: not needed
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

March 22, 2026

Primary Completion (Estimated)

June 22, 2026

Study Completion (Estimated)

July 22, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

After the publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
June 2026-October 2026