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临床试验/CTRI/2025/12/099621
CTRI/2025/12/099621尚未招募3 期

Effect of Sensorimotor Training on Balance and Cognitive Performance in Community Dwelling Elderly with Type II Diabetes Mellitus- A Randomized Controlled Trial

TMVs Lokmanya Tilak College of Physiotherapy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月12日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Fullerton Advanced Balance Scale

研究概览

简要总结

This study is a randomized, single blind, parallel group trial to study the effect of 4 week sensorimotor training on balance and cognitive performance in 40 community dwelling elderly within 65-84 years with Type 2 Diabetes Mellitus. Several studies found that aging and diabetes mellitus is accompanied with decline in cognitive and sensorimotor functions due to several physiological and pathological changes. There are very limited studies which shows effect of specific sensorimotor training on balance and cognitive performance in elderly with Type 2 Diabetes Mellitus. Thus the primary outcome to assess balance and cognitive performance in elderly with Type 2 Diabetes Mellitus is Fullerton Advance Balance scale and MoCA scale respectively.

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
65.00 Year(s) 至 84.00 Year(s)(—)
性别
All

入选标准

  • •Age 65-84 year old male and female with Type II Diabetes Mellitus for more than 1 year.
  • •Walking ability:- should be able to walk freely with or without support.
  • •Berg balance scale score less than equal to 40 ( medium to high risk of fall) MoCA scale score less than equal to 24 (mild to moderate cognitive impairment).

排除标准

  • •Diagnosis of cardiovascular, rheumatologic, neurologic or musculoskeletal diseases that might interfere with daily life activities.
  • •Use of drugs that might potentially have negative effects on cognition, alertness and psychomotor function (opioids, Antiepileptics, anxiolytic, antipsychotic, hypnotics, sedatives) Presence of vestibulopathies.
  • •Injuries in lower limb or history of fractures in last 6 months.
  • •Patient with uncontrolled diabetes.

结局指标

主要结局

Fullerton Advanced Balance Scale

时间窗: 4 weeks

MoCA Scale

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
TMVs Lokmanya Tilak College of Physiotherapy
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sharanya Bapat

TMVs Lokmanya Tilak College of Physiotherapy

研究点 (1)

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