| CTRI Number |
CTRI/2026/01/100811 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Computer based feedback to improve body balance in overweight individuals |
|
Scientific Title of Study
|
Evaluating postural balance through biofeedback-enhanced yoga in android type obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Athira M Das |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Physiology
AIIMS Bibinagar
Telangana
Hyderabad TELANGANA 508126 India |
| Phone |
9944902171 |
| Fax |
|
| Email |
athiramd22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhuri Taranikanti |
| Designation |
Additional professor |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Physiology
AIIMS Bibinagar
Telangana
TELANGANA 508126 India |
| Phone |
8008366030 |
| Fax |
|
| Email |
madhtara18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Athira M Das |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Physiology
AIIMS Bibinagar
Telangana
TELANGANA 508126 India |
| Phone |
9944902171 |
| Fax |
|
| Email |
athiramd22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiology
AIIMS Bibinagar
Telangana 508126 |
|
|
Primary Sponsor
|
| Name |
Dr Athira M Das |
| Address |
Department of Physiology
AIIMS Bibinagar
Telangana 508126 |
| 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 Athira M Das |
AIIMS Bibinagar, Telangana |
Clinical Physiology Lab
First floor, Academic block
Department of Physiology
Hyderabad TELANGANA |
9944902171
athiramd22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Android type obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biofeedback |
By delivering real-time visual biofeedback while performing yoga stances in individuals with android type obesity about weight distribution symmetry and CoP Parameters |
| Comparator Agent |
Without biofeedback |
Performing yoga stances in individuals with android type obesity without real time visual biofeedback |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 30 to 50 years
2)Android type obesity with waist to hip ratio greater than 0.90 for males and greater than 0.85 for females
3)Normal visual field and acuity the subjects able to wear eye glasses
4)The ability to stand in a bipedal position with the eyes closed and without help for 1 minute or more
5)The ability to stand on one leg for 10 seconds or more
|
|
| ExclusionCriteria |
| Details |
1)A history of musculoskeletal disorders
2)A history of neurological disorders
3)A history of back or lower limb surgery
4)The presence of any joint diseases such as osteoarthritis gout or rheumatoid arthritis
5)History of visual or vestibular diseases
6)History of medications affecting balance
7)Individuals already practicing yoga
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight distribution symmetry and Centre-of-pressure (CoP) metrics (Sway distance,
velocity, path length) |
1st week,2nd week and 3rd week
Twice in each week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Berg balance scale scores |
1st week, 3rd week |
|
|
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)
|
27/01/2026 |
| 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="2" 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [athiramd22@gmail.com].
- For how long will this data be available start date provided 26-12-2028 and end date provided 26-12-2038?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled pilot study aim to evaluate whether real time visual biofeedback improves postural balance in adults with android type obesity. Central obesity alters the center of mass and increases postural sway leading to a higher risk of falls and reduced functional independence. Falls in obese adults not only lead to injury and loss of independence but also impose considerable healthcare costs and diminish quality of life. Thirty android obese adults aged 30 to 50 years will be randomly allocated with (computer generated randomization) into two groups. The intervention group will perform selected standing yoga postures on a Balance Board with real time visual biofeedback while the parallel group will perform the same yoga protocol without biofeedback. Training will be conducted in six sessions over three weeks (twice weekly) with supervised sessions. Balance will be assessed using center of pressure sway measures derived from the balance board and functional balance will be evaluated using the Berg Balance Scale. Anthropometric measures related to central obesity will also be recorded. The study is expected to demonstrate greater reductions in postural sway (COP velocity/movement area) in group with biofeedback compared to the group without biofeedback. Thus reflecting enhanced sensory reweighting and motor strategy adaptation with larger gains in functional balance with higher Berg Balance Scale scores consistent with biofeedback. Also we expect an improved weight-distribution symmetry and better retention of balance gains at follow-up, indicating accelerated motor learning. The added benefit from biofeedback-enhanced yoga is that it can aid will in low-cost, community-deployable programs to prevent falls in individuals with android type obesity. |