| CTRI Number |
CTRI/2025/11/098055 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Screening Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Balance and Dizziness Problems After a Head Concussion |
|
Scientific Title of Study
|
Clinical and Vestibular Assessment of Vertigo Following Head Concussion: A Prospective Observational Study |
| Trial Acronym |
STAND-Bi |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunjan Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patna Medical College & Hospital |
| Address |
Department of Neurology
Patna Medical College & Hospital
Patna
Bihar
Patna BIHAR 800004 India |
| Phone |
9341334340 |
| Fax |
|
| Email |
drgunjankumar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gunjan Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patna Medical College & Hospital |
| Address |
Department of Neurology
Patna Medical College & Hospital
Patna
Bihar
Patna BIHAR 800004 India |
| Phone |
9341334340 |
| Fax |
|
| Email |
drgunjankumar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Darshpreet Kaur PT |
| Designation |
Director- Physiotherapy |
| Affiliation |
Neuro Vihar |
| Address |
Neuro Vihar
Department of Physiotherapy
c/0 Ajay Bhawan
South of Bailey road
Rukanpura
Patna
Patna BIHAR 800014 India |
| Phone |
9620299373 |
| Fax |
|
| Email |
neurovihar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro Vihar
c/o Ajay Bhawan, South of Bailey Road Railway Bridge
Rukanpura
Patna,Bihar-800014 |
|
|
Primary Sponsor
|
| Name |
Neuro Vihar |
| Address |
Neuro Vihar
c/o Ajay Bhawan
South of Bailey road Railway Bridge
Rukanpura
Patna |
| Type of Sponsor |
Other [self financed by institute] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DARSHPREET KAUR PT |
NEURO VIHAR |
DEPARTMENT OF PHYSIOTHERAPY
NEURO VIHAR
C/O AJAY BHAWAN
SOUTH OF BAILEY ROAD RAILWAY BRIDGE
RUKANPURA Patna BIHAR |
9620299373
NEUROVIHAR@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BSL Eye Care |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H814||Vertigo of central origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Single Group |
1. Clinical Neurological Examination
2. Detailed Vertigo History and Symptom Profiling
(using tools like the Dizziness Handicap Inventory, Post-Concussion Symptom Scale)
3. Vestibular Bedside Testing
(Dix-Hallpike, Head Impulse Test, Fukuda Step Test, Romberg, Tandem Gait)
4. Audiological Evaluation (if necessary)
5. Instrumental Vestibular Function Testing (e.g., VNG, VEMP)
6. Follow-up Assessments at 1 month and 3 months to observe symptom evolution
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients aged 18 years and above
• History of head concussion within the past 3 months
• Presence of vertigo, dizziness, or imbalance post-head injury
• Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Any other neurological disorder
GCS lower than 13
Known pre-existing Vestibular Disorder
Unco-operative patient
Patient on vestibular suppressants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence and types (central vs. peripheral) of vertigo in patients with head concussion (mTBI). |
Baseline, 1 month ,3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o Duration of symptoms
o Response to treatment (medical or rehabilitation)
o Impact on quality of life and daily functioning
|
Baseline, 1 month ,3 month |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Head concussion, or mild traumatic brain injury (mTBI), is a frequent presentation in emergency and outpatient settings. A significant proportion of patients with mTBI experience vestibular symptoms, including vertigo, dizziness, imbalance, and visual instability. These symptoms may stem from peripheral causes (e.g., benign paroxysmal positional vertigo—BPPV, labyrinthine concussion) or central causes (e.g., brainstem or cerebellar dysfunction), making timely diagnosis and management essential.
Underdiagnosis and Mismanagement: Vestibular symptoms post-concussion are frequently under-recognized and misattributed to non-vestibular causes, resulting in incomplete assessment and treatment. Lack of interdisciplinary coordination among neurologists, ENT specialists, and physiotherapists further delays appropriate care. In resource-limited settings like Bihar, the challenge is compounded by the scarcity of trained personnel and diagnostic infrastructure for vestibular assessment.
Need for Objective Evidence: There is a dearth of systematic, prospective data from India—particularly from Bihar—on the type and extent of vestibular dysfunction following concussion. Most available literature is from Western populations with different healthcare access and injury patterns. An observational study involving bedside testing and vestibular evaluations can provide vital local data to guide clinical practice and policy in such regions.
Potential Impact:
This study will help define the clinical spectrum of post-concussive vertigo. It will assess the diagnostic utility of bedside vestibular tests in identifying treatable causes of dizziness. It will help establish referral pathways and integrate vestibular physiotherapy into concussion care protocols. It will lay the foundation for future interventional studies targeting early recovery and rehabilitation of concussion-induced vertigo. Conclusion: Given the clinical burden, patient suffering, and diagnostic ambiguity surrounding post-concussive vertigo—especially in tertiary centers catering to underserved populations—this study is both timely and clinically relevant. It aims to bridge the knowledge and practice gap in the diagnosis and management of dizziness following head concussion in Bihar. |