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临床试验/NCT05786690
NCT05786690尚未招募不适用

The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption in Above Knee Ampute Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital0 个研究点目标入组 34 人开始时间: 2023年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
主要终点
6MWT

研究概览

简要总结

The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

详细描述

Background: The use of microprocessor controlled (MIC) prostheses has increased in recent years, but the number of studies on gait pattern and energy consumption in above-the-knee amputee patients is very low.

Objective

The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Methods: This observational clinical study included 34 unilateral above-the-knee amputees, separated into two groups as Group 1 (n:17) using MIC prosthesis, and Group 2 (n:17) using non-MIC prosthesis. The patients were compared in terms of gait pattern, gait capacity, energy consumption, mobility, quality of life, and prosthesis satisfaction levels according to the type of prosthesis. 3D gait analysis, exercise tolerance test, Short Form 36 (SF-36) Health Survey Questionnaire, Locomotor Capabilities Index-5 (LCI-5), Satisfaction with Prosthesis Questionnaire (SAT-PRO) and six-minute walk test (6MWT) were used as evaluation criteria.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • as voluntary participation in the study
  • age ≥18 years
  • having a unilateral above-the-knee amputation
  • the ability of independent ambulation in the community
  • at least 6 months since the amputation
  • use of the current prosthesis for at least 8 weeks

排除标准

  • unwillingness to participate in the study
  • age <18 years
  • limb length discrepancy of ≥2 cm
  • the presence of contracture or deformity
  • additional amputation
  • neuromuscular disease or comorbidity that may interfere with the study follow-up period of < 6 months since the amputation
  • use of the current prosthesis for < 8 weeks
  • being uncooperative

结局指标

主要结局

6MWT

时间窗: through study completion, an average of one and a half months

6 minute walk test

次要结局

未报告次要终点

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Demir

Associated Professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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