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临床试验/CTRI/2021/12/038733
CTRI/2021/12/038733已完成2 期

A Study on Effect of alteration in angular alignment on Balance and Posture in subjects with valgus stump using unilateral transtibial prosthesis

wami Vivekanand National Institute of Rehabilitation Training and Research1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
2.Stability score (%)

研究概览

简要总结

The objective of this study is to check whether significant difference exist between any of the three alignment alteration conditions (Neutral,N+5,N+10) with respect to balance and postural  parameters  in subjects with valgus stump using unilateral trnastibial amputation.

HYPOTHESIS:

There will be significant improvement in static balance and posture due to alternation of prosthetic alignment

NULL HYPOTHESIS:

There will not be any significant differences in static balance and posture by due to alternation of prosthetic alignment.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • •Only unilateral transtibial amputees will be considered.
  • •Short Stump with valgus alignment up to 20 degrees.
  • •Full ROM of shoulder, elbow and wrist joint and strength minimum more than 4 in MMT.
  • •No contracture in the proximal joint.
  • •Able to understand the command.

排除标准

  • •Other associated Neurological or Orthopaedical condition, Complicated stump (pain, wound, etc), Significant pathology in cardiopulmonary status.

结局指标

主要结局

2.Stability score (%)

时间窗: At 1 Week Intervals

4.Mobility score (%)

时间窗: At 1 Week Intervals

8. Ground Reaction Forces (Kinetics)

时间窗: At 1 Week Intervals

5.Postural Compensation (mm)

时间窗: At 1 Week Intervals

1.Path length or COP displacement (cm)

时间窗: At 1 Week Intervals

3.Average Velocity (cm/sec)

时间窗: At 1 Week Intervals

6. Temporal-Spatial Gait parameters

时间窗: At 1 Week Intervals

7. Kinematics of Hip, Knee and Ankle

时间窗: At 1 Week Intervals

次要结局

  • Patient Satisfaction Level and Quality of Life(500 Min)

研究者

发起方
wami Vivekanand National Institute of Rehabilitation Training and Research
申办方类型
Research institution and hospital

研究点 (1)

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