| CTRI Number |
CTRI/2026/04/108210 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating balance and body stability in people with fibromyalgia using a computerised balance assessment system |
|
Scientific Title of Study
|
Screening of postural control and balance in fibromyalgia syndrome - A cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetna dave |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement department of physiotherapy Manipal hospital no 98 rustam bagh old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
8619947380 |
| Fax |
|
| Email |
chetna.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Additional professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of physiotherapy, Manipal hospital #98, HAL, old airport road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Additional professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of physiotherapy, Manipal hospital #98, HAL, old airport road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal college of Health Professionals, Manipal Academy of Higher Education, 98, HAL road, Karnataka, 560017,India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher education |
| Address |
Department of physiotherapy Manipal college of health professionals Manipal Academy of higher education , 98, old airport road, rustam bagh, Bangalore, Karnataka, 560017, india |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chetna dave |
Manipal hospitals |
Upper basement, department of physiotherapy, Manipal hospital no 98, rustam bagh, old airport road
Bangalore
KARNATAKA |
8619947380
chetna.mhsblr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Adult diagnosed with fibromyalgia syndrome based on inclusion criteria
Age range 18-65
female |
|
| ExclusionCriteria |
| Details |
Presence of other disorders affecting balance like diabetes, osteoporosis, post menopausal women.
Recent injuries or surgeries affecting balance within past 6 months
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Revised fibromyalgia impact questionnaire
Biodex balance system |
Only at baseline while recruiting the patient at the point of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
24/04/2026 |
| 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)
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
|
There is limited evidence on objective assessment of postural balance in Fibromyalgia Syndrome (FMS)therefore, this study uses the Biodex Balance System to profile balance deficits, helping to better understand balance impairments and support evidence-based physiotherapy interventions to reduce fall risk and improve quality of life in FMS patients. |