跳至主要内容
临床试验/CTRI/2025/12/099816
CTRI/2025/12/099816尚未招募2/3 期

Development, Validation and Feasibility Testing of a Hip and Ankle Strategy based Somatosensory Training Protocol in Individuals with Diabetic Peripheral Neuropathy

Maharishi Markandeshwar (Deemed to be University)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

The study will be conducted in tertiary care Superspeciality hospital in 3 phases; development of protocol, its content validation and feasibility testing. In first phase, based on the literature showing positive effects in improving somatosensory functions and balance, a structured exercise protocol will be developed which incorporates closed chain hip and ankle exercises and somatosensory exercises.  In second phases, content validity of exercise protocol was measured and items will be eliminated or revised if score is less after expert’s evaluations. Total 30 participants will be recruited in third phase i.e. feasibility trial by Criterion-Based Purposive sampling method. After signing the consent form, participants will be assessed at baseline, after 2 week, 4 week and 6 week by selected outcome measures. Experimental group receives newly developed hip and ankle strategy-based somatosensory training protocol and conventional group receives hip strengthening exercises, ankle strengthening exercises, and weight bearing activities on unstable surface. Normality will be assessed by Shapiro-wilk test. If p-value is less than 0.05, indicates data is not normally distributed and p-value more than 0.05 indicates data is normally distributed. If the data is distributed normally, parametric tests will be used for within group analysis, between group analysis, and repeated measure analysis. If the data is not normally distributed, non-parametric test will be used. P-value less than 0.05 indicate significant results and more than 0.05 indicate statistical significant results.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Pre-diagnosed cases of DPN or Type II diabetes mellitus for 5 years BMI 18.5 to 29.9 kg per m2 Scored more than 2 out of 13 on Michigan Neuropathy Screening Instrument questionnaire HbA1C report more then or equal to 6 percent and not older than 3 months Willing to participate in study.

排除标准

  • Severe Musculoskeletal impairment of lower limb Any other diagnosed neurological impairment Severe Retinopathy Severe Nephropathy Foot Ulcers Major Vascular Complication Unable to walk independently with or without an assistive device.

研究者

发起方
Maharishi Markandeshwar (Deemed to be University)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jatin Sangwan

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

研究点 (1)

Loading locations...

相似试验