Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.
研究概览
简要总结
The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis".
The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people.
This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Amputee at or above knee level
- •Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
- •Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
- •Person able to understand simple commands, to read and write, and to give their informed consent
- •Person who has given informed consent
- •Person affiliated to a social security scheme
排除标准
- •Person of full age subject to a legal protection measure or unable to express consent
- •Pregnant or breast-feeding women
- •Persons with bilateral amputations
- •Person with a neurological or orthopedic pathology with major repercussions on locomotion
- •Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
- •Persons weighing more than 125 kg
- •Foot size less than 24 cm or greater than 30 cm
- •Person with a hip disarticulation
- •Person without an emergency walking solution
- •Person with a suspension fitting with vacuum pump
- •Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.
结局指标
主要结局
Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.
时间窗: Evaluation after 4 weeks' wear of each of the 2 prostheses
The aim is to compare the adaptation of the prosthetic system to the constraints of everyday life. SPCM adapts the ankle's behavior to the walking situation, and should make it possible to restore the time during which the foot remains flat during the stance phase, in different situations
次要结局
- Prosthesis evaluation(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Mobility(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- SF-36 Questionnaire(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Number of steps(Evaluation after 4 weeks' wear of SPCM)
- Contralateral ankle power(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Pelvis elevation(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Toe clearance(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Locomotor abilities(Evaluation after 4 weeks' wear of each of the 2 prostheses)
- Cadence(Evaluation after 4 weeks' wear of SPCM)