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Clinical Trials/CTRI/2025/12/098328
CTRI/2025/12/098328
Not yet recruiting
Phase 1/2

Effectiveness of Tele-Rehabilitation-Based Balance Training for Balance Dysfunction in Children With Juvenile Diabetes: A Randomized Controlled Trial

Sejal Achari Shambhavi Kamat Tanvi B1 site in 1 country30 target enrollmentStarted: December 15, 2025Last updated:

Overview

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Sejal Achari Shambhavi Kamat Tanvi B
Enrollment
30
Locations
1
Primary Endpoint
Bruininks-Oseretsky Test of Motor Proficiency - 2nd Edition (BOT-2)

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
10.00 Year(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children aged 10 to 18 years diagnosed with juvenile diabetes for more than or equal to 5 years of diagnosed T1DM.

Exclusion Criteria

  • Other neurological or musculoskeletal disorders
  • Recent injury or surgery affecting balance
  • Severe visual or auditory impairments
  • Syndromic diabetes
  • Parents and children not willing to participate in the study
  • Children who are not diagnosed with juvenile diabetes.

Outcomes

Primary Outcomes

Bruininks-Oseretsky Test of Motor Proficiency - 2nd Edition (BOT-2)

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sejal Achari Shambhavi Kamat Tanvi B
Sponsor Class
Other [self-sponsored]
Responsible Party
Principal Investigator
Principal Investigator

Dr. Sneha Mhetre

KAHER Institute Of Physiotherapy

Study Sites (1)

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