| CTRI Number |
CTRI/2025/09/094938 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vestibular Migraine in Perimenopausal Women: Prevalence and Effect of Integrated Exercises on Balance, Disability, Electroencephalogram and Quality of Life |
|
Scientific Title of Study
|
Effect of Integrated Exercises on Balance, Level of Disability,
Electroencephalogram and Quality of Life in Perimenopausal Women with
Vestibular Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rabab Kaur |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
09654478155 |
| Fax |
|
| Email |
rabab_kaur23.phd@mriu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshitija Bansal |
| Designation |
Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9810314488 |
| Fax |
|
| Email |
kshitijabansal.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rabab Kaur |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rabab_kaur23.phd@mriu.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute Of Research And Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, India, Faridabad, Haryana, 121004 |
|
|
Primary Sponsor
|
| Name |
Rabab Kaur |
| Address |
Manav Rachna International Institute of Research and Studies, Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
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 Kshitija Bansal |
Manav Rachna International institute of Research and Studies |
Plot A, Manav
Rachna
Campus Road,
Gadakhor Basti
Village, Sector
- 43, Faridabad
Faridabad
HARYANA
Faridabad
HARYANA |
9810314488
kshitijabansal.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee, MRIIRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal females with Vestibular Migraine |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Group B will receive conventional therapy including strengthening exercises of the neck muscles for 6 weeks along with lifestyle modification and relaxation techniques, which will be explained verbally, and participants will also be provided with pamphlets. Participants will also be asked to maintain a daily diary to keep track of the same. |
| Intervention |
Experimental Group |
Group A will receive an integrated exercise intervention including Vestibular Rehabilitation which consists of gaze stabilization, habituation exercises, and vestibulospinal reflex exercises for 6 weeks along with lifestyle modification and relaxation techniques, which will be explained verbally, and participants will also be provided with pamphlets. Participants will also be asked to maintain a daily diary to keep track of the same. |
|
|
Inclusion Criteria
|
| Age From |
42.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Perimenopausal women diagnosed with vestibular migraine.
2. Age: 42-55 years
3. BMI: 18.5kg/m2-29.9kg/m2 (Normal to Pre-obesity according to WHO)
4. Berg Balance Score less than or equal to 40
5. MIDAS score greater than or equal to 11 |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled hypertension and diabetes
2. Diagnosed with neurological disorders (e.g., epilepsy, multiple sclerosis) or vestibular
disorders (e.g., Meniere’s disease, benign paroxysmal positional vertigo)
3. Women with significant musculoskeletal disorders or injuries in last 6 months
4. Women with uncorrected vision or hearing impairments
5. Any recent surgeries in the last 6 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
Star Excursion Balance Test
Migraine Disability Assessment Scale (MIDAS)
QoL: World Health Organization Quality of Life Questionnaire Short Form - 12(WHOQL-SF12)
Electroencephalography (EEG)
|
2 times
2 times
2 times
2 times
2 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/01/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rabab_kaur23.phd@mriu.ac.in].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|