跳至主要内容
临床试验/NCT07731698
NCT07731698尚未招募不适用

Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis: A Randomized Controlled Trial

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Balance assessed using the Biodex Stability System Overall Stability Index (OSI)

研究概览

简要总结

This prospective randomized controlled trial aims to investigate the effect of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18-60 years will be randomly allocated to either an experimental group receiving dual-task training in addition to conventional therapy or a control group receiving conventional therapy alone. The intervention will be conducted for 8 weeks, 3 sessions per week. Balance and fall risk will be evaluated before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test.

详细描述

Lower limb amputation is associated with impaired balance, gait asymmetry, and an increased risk of falls due to loss of proprioceptive input and biomechanical alterations. Individuals with transfemoral amputation frequently encounter difficulties performing everyday activities that require simultaneous motor and cognitive tasks. Dual-task training has emerged as a rehabilitation strategy designed to improve automaticity of movement, balance control, and functional mobility under real-life conditions.

This study is a prospective randomized controlled trial designed to evaluate the effectiveness of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18 to 60 years who have used a prosthetic limb for at least six months and are able to walk independently will be randomly assigned to either an experimental group or a control group. Randomization will be performed using a computer-generated randomization sequence with allocation concealment by sealed opaque envelopes.

The experimental group will receive conventional physiotherapy combined with dual-task training, including motor-cognitive and motor-motor activities such as walking while counting backward, naming categories, obstacle negotiation with memory tasks, carrying objects during walking, and ball passing. The control group will receive conventional physiotherapy consisting of strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional training. Both groups will participate in supervised treatment sessions three times per week for eight weeks, with each session lasting 45-60 minutes.

Outcome measures will be collected before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test. The study aims to determine whether adding dual-task training to conventional rehabilitation improves balance and reduces fall risk more effectively than conventional therapy alone in individuals with unilateral transfemoral amputation using a prosthesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ranging from 18 to 60 years.
  • Unilateral transfemoral amputation.
  • Use of a prosthetic limb for at least 6 months.
  • Ability to walk independently with or without assistive devices.
  • Medically stable condition.
  • Ability to understand and follow study instructions.

排除标准

  • Bilateral amputation.
  • Severe visual or vestibular disorders.
  • Neurological conditions (e.g., stroke, Parkinson's disease)
  • Cognitive impairment affecting task performance.
  • Musculoskeletal conditions affecting the intact limb.

结局指标

主要结局

Balance assessed using the Biodex Stability System Overall Stability Index (OSI)

时间窗: Baseline and after 8 weeks of intervention

Balance will be evaluated using the Biodex Stability System by measuring the Overall Stability Index (OSI). Lower OSI values indicate better postural stability. Assessments will be performed before and after the 8-week intervention.

次要结局

  • Berg Balance Scale (BBS)(Baseline and after 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khalid Saleh Kamal Muhanna

Master's Student, Faculty of Physical Therapy, Kafrelsheikh University

Kafrelsheikh University

研究点 (1)

Loading locations...

相似试验