跳至主要内容
临床试验/CTRI/2024/10/075298
CTRI/2024/10/075298招募中不适用

Incidence of falls and fall risk in persons ambulating with unilateral lower limb prosthesis.

Sneha Saravanakumar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
1.Gait speed in m/s to assess fall risk in persons with unilateral lower limb prosthesis.

研究概览

简要总结

Primary purpose of the study : To assess incidence of falls and fall risk among persons ambulating with unilateral lower limb prosthesis.

Objectives :

  1. To assess incidence of falls among persons ambulating with unilateral transfemoral and transtibial prosthesis.

  2. To assess fall risk among persons ambulating  with unilateral transfemoral and transtibial prosthesis with low and high speed prospectively over a period of one year (0,6 and 12 months)

  3. To compare functional mobility ( outcome measure - TUG in secs  ) and fear of fall ( outcome measure - FES score ) among persons ambulating with unilateral transfemoral and transtibial prosthesis with high and low speed.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Person, a community ambulator with unilateral lower limb prosthesis, 3 months post completion of rehabilitation program.

排除标准

  • Person with any central neurological conditions eg: stroke,Parkinsons disease,Spinal cord injury,Multiple scerosis,Hereditary ataxia.
  • Persons with cognitive impairment.
  • Persons with any psychological disorders.

结局指标

主要结局

1.Gait speed in m/s to assess fall risk in persons with unilateral lower limb prosthesis.

时间窗: 1.Gait speed in m/s to assess fall risk in persons with Unilateral lower limb prosthesis prospectivey over a period of 0, 6 and 12 months.

2.Incidence of fall.

时间窗: 1.Gait speed in m/s to assess fall risk in persons with Unilateral lower limb prosthesis prospectivey over a period of 0, 6 and 12 months.

次要结局

  • 1. TUG(Timed Up and Go test) score in secs.(2. Fall efficacy scale (FES)score.)

研究者

发起方
Sneha Saravanakumar
申办方类型
Other [Under Ministry of Health and Family welfare, Goverment of India]
责任方
Principal Investigator
主要研究者

Sneha Saravanakumar

All India Institute of Physical Medicine and rehabilitation.

研究点 (1)

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