跳至主要内容
临床试验/CTRI/2025/12/098328
CTRI/2025/12/098328尚未招募1/2 期

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 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Bruininks-Oseretsky Test of Motor Proficiency - 2nd Edition (BOT-2)

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
10.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 1 month

次要结局

未报告次要终点

研究者

发起方
Sejal Achari Shambhavi Kamat Tanvi B
申办方类型
Other [self-sponsored]
责任方
Principal Investigator
主要研究者

Dr. Sneha Mhetre

KAHER Institute Of Physiotherapy

研究点 (1)

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