Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 13
- 主要终点
- Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
研究概览
简要总结
The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.
详细描述
The study is divided into three phases. The initial phase lasts 6 to 8 weeks for each subject. For subjects of group 2 the length of the initial phase depends on the progression of the re-innervation. The initial phase ends, when the subject can perceive the tactile stimulate at the re-innervated area of the skin. During the initial phase, all subjects get a new prosthesis. To minimize the adjusting to the new prosthesis only a new socket, which houses the vibro-tactile Feedback system, is fabricated and the old prosthetic food is re-used. After a period of 3 weeks minimum, where the subjects use the new prosthesis, a gait analysis and an assessment of the sensitivity of the skin at the stump are performed.
Subsequently the intervention phase starts and the vibro-tactile feedback system is activated. For a period of 6 months the subjects use the new prostheses with the integrated vibro-tactile feedback system in daily living. After 2 and 4 months, the subjects visit the study site for an assessment of the sensitivity of the skin. After 6 months a second gait analysis and an other assessment of the sensitivity of the skin a the stump are performed. Afterwards the vibro-tactile feedback-system is disabled.
During the observing phase the subjects use the prosthesis with the disabled vibro-tactile feedback system for 4 months.
During all three phases the subjects answer the questionnaires every 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral trans-tibial amputation
- •uses a prostheses already for more than 1 year
- •sufficient touch sensitivity at the stump
- •unimpaired contralateral lower extremity
排除标准
- •psychiatric disorder
- •cognitive restrictions
- •pregnant or breast feeding women
结局指标
主要结局
Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
时间窗: 1 year
The Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) is a multidimensional instrument designed to examine the psychosocial processes involved in adjusting to amputation and a prosthesis. TAPES consists of 9 subscales, with possible scores depending on the single subscale. The range is from 0-12 to 0-25 (depending on the number of items and answer possibilities).
次要结局
- Gait parameters(6 months)
- Fall Efficacy Scale International Version (FES-I)(1 year)
- two point discrimination(6 months)
- Pain Visual analoge scale (VAS)(1 year)
- touch perception threshold(6 months)
- Number of falls within the last two months(1 Year)
研究者
Agnes Sturma
Physical Therapist, Research Fellow
Medical University of Vienna