| CTRI Number |
CTRI/2025/12/098328 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How well tele-rehabilitation -based balance training works for kids with juvenile diabetes who have trouble keeping their balance |
|
Scientific Title of Study
|
Effectiveness of Tele-Rehabilitation-Based Balance Training for Balance Dysfunction in Children With Juvenile Diabetes: A Randomized Controlled Trial |
| 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. Sneha Mhetre |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy centre ,Room no. 39, Department of Paediatric Physiotherapy,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9145024691 |
| Fax |
|
| Email |
snehamhetre@klekipt.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sneha Mhetre |
| Designation |
Associate Professor |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy centre ,Room no. 39, Department of Paediatric Physiotherapy,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9145024691 |
| Fax |
|
| Email |
snehamhetre@klekipt.in |
|
Details of Contact Person
Public Query
|
| Name |
Sejal Satish Achari |
| Designation |
Intern |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced physiotherapy centre ,Room no. 39, Department of Paediatric Physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8390356870 |
| Fax |
|
| Email |
sejalachari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced physiotherapy centre ,Room no. 39, Department of Paediatric Physiotherapy,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010 |
|
|
Primary Sponsor
|
| Name |
Sejal Achari Shambhavi Kamat Tanvi B |
| Address |
Advanced physiotherapy centre ,Room no. 39, Department of Paediatric Physiotherapy,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre , Belgaum , Karnataka ,590010 |
| Type of Sponsor |
Other [Self-Sponsored] |
|
|
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 Sneha Mhetre |
KLE Hospital |
JNMC campus, Nehru Nagar, Belagavi,Karnataka,590010
Belgaum
KARNATAKA |
9145024691
snehamhetre@klekipt.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balance Training Exercises |
3 days per week for 4 weeks |
| Comparator Agent |
Basic education |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 10 to 18 years diagnosed with juvenile diabetes for more than or equal to 5 years of diagnosed T1DM |
|
| ExclusionCriteria |
| Details |
1. Other neurological or musculoskeletal disorders
2. Recent injury or surgery affecting balance
3. Severe visual or auditory impairments
4. Syndromic diabetes
5. Parents and children not willing to participate in the study
6. Children who are not diagnosed with juvenile diabetes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bruininks-Oseretsky Test of Motor Proficiency - 2nd Edition (BOT-2) |
1 month |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="0"
Months="6"
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 - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 25-11-2025 and end date provided 12-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The thesis investigates the effectiveness of a tele-rehabilitation-based balance training program for children aged 10–18 years with juvenile (type 1) diabetes who have had the illness for at least five years. These children are at high risk for subclinical balance and vestibular dysfunctions due to chronic hyperglycemia-related neuropathic complications. In this randomized controlled trial, eligible participants are randomized into an intervention group—receiving supervised tele-rehabilitation balance exercises thrice weekly for 4 weeks—and a control group—receiving standard care and education only. Balance is assessed pre- and post-intervention primarily using the Balance subtest of the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2), a validated pediatric tool, and changes in glycemic control (HbA1c) are also monitored. The study aims to determine whether a structured, remotely delivered program can significantly improve balance and postural control compared to routine care, and to assess feasibility and acceptability in this pediatric cohort |