跳至主要内容
临床试验/CTRI/2025/01/079327
CTRI/2025/01/079327尚未招募不适用

Comparative analysis of balance between non diabetic and diabetic individuals with Unilateral Transtibial Amputation using Endoskeletal Prosthesis during turning and negotiating steps.

Vaibhav Dolas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. STEP/QUICK TURN (SQT) - Turn time & Turn sway velocity

研究概览

简要总结

Title - Comparative analysis of balance between non diabetic and diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and negotiating steps.

Aim - To evaluate and compare balance between non-diabetic and diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during and stair climbing.

Objective - 1. To assess the balance in non-diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and stair climbing.

  1. To assess the balance in diabetic individuals with unilateral transtibial amputation using endoskeletal prosthesis during turning and stair climbing.

  2. To compare balance between persons with non-diabetic and diabetic unilaterl transtibial amputation using endoskeletal prosthesis during turning and stair climbing.

Participant giving informed consent will be included in the study.

Data collected from the study will be statistically analysed.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Two groups Group I Persons with Non–Diabetic unilateral Transtibial amputation using PTB endoskeletal prosthesis.
  • Group II Persons with Diabetic Unilateral Transtibial amputation using PTB endoskeletal prosthesis.
  • Functional level K3 (K- level functional assessment scale)
  • Persons using prosthesis for more than 3 months.
  • Persons ambulating independently without any walking aid.

排除标准

  • 1.Amputees with a stump length of less than 1/3 rd and more than 2/3 rd of the unaffected leg
  • Any clinical manifestation or condition which will affect the performance.

结局指标

主要结局

1. STEP/QUICK TURN (SQT) - Turn time & Turn sway velocity

时间窗: Only baseline.

2. STEP UP/OVER (SUO) - Rising index

时间窗: Only baseline.

(force to rise) movement time and impact index (impact force)

时间窗: Only baseline.

次要结局

未报告次要终点

研究者

发起方
Vaibhav Dolas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vaibhav Dolas

AIIPMR, Mumbai

研究点 (1)

Loading locations...

相似试验