Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 30
- 主要终点
- Timed Get Up and Go (TGUG)
研究概览
简要总结
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.
The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.
详细描述
The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing.
After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •Person with leg amputation above knee or knee disarticulation with stabilized residual limb
- •Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee
- •Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds
- •Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private
- •Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation
- •Person with a daily walking distance greater than 300 m
排除标准
- •Persons using underarm crutches or walkers
- •Persons under 18 years of age
- •Persons who weigh more than 125 kg
- •Pregnant women
- •Persons in an emergency situation
- •Persons who cannot personally provide their consent
- •Persons who are not available to follow the entire study protocol
结局指标
主要结局
Timed Get Up and Go (TGUG)
时间窗: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
This test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.
次要结局
- Number of Falls(Measurement will be performed at 1 month with both devices)
- SF-36v2™ Health Survey(Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK)
- Locomotor Capabilities Index (LCI-5)(Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK)
- Use of Walking Aids(Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK)
- QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)(Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK)