Post Concussion SyndromePCS BESS IPRRSNCT07401706
Effects of Vestibular Rehabilitation and Routine Physical Therapy in Athletes With Post Concussion Syndrome
A study testing Intervention 1 in people with Post Concussion Syndrome, run by Lahore University of Biological and Applied Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Post Concussion Syndrome
- What is being tested?
- Intervention 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Vestibular Rehabilitation in Comparison With Routine Physical Therapy on Stability, Kinesiophobia and Return to Sports in Athletes With Post Concussion Syndrome
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.
- Conditions
- Post Concussion Syndrome
- Being tested
- Intervention 1, Control Arm (Conventional Therapy)
- Keywords
- TAMPA, BESS, IPRRS, RPT, Athletes, Post concussion syndrome, vestibular rehabilitation, stability, kinesiophobia, return to sports
- Medical subject headings
- Post-Concussion Syndrome, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Other
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
Control Arm (Conventional Therapy)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Arm (Conventional Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = strongly disagree
- = disagree
- = agree
- = 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)
Measured: 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
Measured: 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: ________
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start22 Mar 2026 (estimated)
- Primary completion22 Jun 2026 (estimated)
- Study completion22 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- not needed
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tariq Shafi, Study chair, Lahore University of Biological And Applied Health SciencesSyeda Farwa Aitbar, DPT, Principal investigator, Lahore College of Physical TherapyMaheen Mazhar, DPT, Principal investigator, Lahore College of Physical TherapyAyesha Naeem Khan, DPT, Principal investigator, Lahore College of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401706
- Sponsor's protocol ID
- DPT/ERB/25
- Other IDs
- Syeda Farwa Aitbar
- Acronym
- PCS BESS IPRRS
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Rehabilitation in Comparison With Routine Physical Therapy on Stability, Kinesiophobia and Return to Sports in Athletes With Post Concussion Syndrome
- ClinicalTrials.gov ID
- NCT07401706
- Acronym / sponsor ID
- PCS BESS IPRRS / DPT/ERB/25
- Conditions
- Post Concussion Syndrome
- Keywords
- TAMPA, BESS, IPRRS, RPT, Athletes, Post concussion syndrome, vestibular rehabilitation, stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 22 Mar 2026 (estimated)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- not needed
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Other: Intervention 1The 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. |
| Routine Physical Therapy | Active comparator | Other: Control Arm (Conventional Therapy)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. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Have a chronic infectious disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Vestibular 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 | Other | Vestibular Rehabilitation |
| Control Arm (Conventional Therapy)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 | Other | Routine Physical Therapy |
Primary outcome
Kinesiophobia
Time frame: 4 weeks
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)
Stability
Time frame: 4 weeks
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
Return to sports
Time frame: 4 weeks
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: ________
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. After the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tariq Shafi study chair
Lahore University of Biological And Applied Health Sciences
Syeda Farwa Aitbar, DPT principal investigator
Lahore College of Physical Therapy
Maheen Mazhar, DPT principal investigator
Lahore College of Physical Therapy
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 in people with Post Concussion Syndrome, run by Lahore University of Biological and Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tariq Shafi, Post graduation (03454190056, muhammad.tariq@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.