Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Prosthetic Limb User's Survey of Mobility (PLUS-M)
研究概览
简要总结
Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. This study is conducted to evaluate the need to practice these guidelines in order to gain best benefits for the patients. Focus is set of early inpatient rehabilitation and the role of a microprocessor-controlled prothesis (Kenevo, Ottobock).
详细描述
Right after major surgeries, e.g. amputations, inpatient rehabilitation follows in Germany. Costs are covered by different insurances, like public or private health care insurances or German pension insurance. Usually, inpatient rehabilitation lasts for 3 weeks. But after some surgeries, like amputation, patients need more time to recover and fitting of a prosthesis takes additional time. Therefore guidelines state, that rehabilitation should take up to 6-8 weeks after major amputation. To provide evidence to these guidelines, we conducted this study.
Patients' choice on rehabilitation clinic decides on their assignment to the study group or control group. Inpatient rehabilitation is monitored with outcomes measurements. 3 measurements are carried out in the study group within rehabilitational stay of around 6 weeks (admission - middle - discharge) and 2 measurements are carried out in the control group within rehabilitational stay of around 3 weeks (admission - discharge). After discharge from rehabilitation, assessment of patient reported outcome measurements is continued every 6 weeks for both groups. Follow-up phase ends with 24 weeks after admission to rehabilitation.
For subanalysis, different prosthetic devices (non-microprocessor-controlled vs. microprocessor-controlled prosthesis) are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •inpatient rehabilitation stay after transfemoral amputation or knee disarticulation
- •anticipated K-level 1 or 2
- •body weight no more than 125kg (authorized body weight for prosthetic device)
- •German speaking
- •able to give informed consent
排除标准
- •non-German speaking
- •not able to give informed consent
- •body weight over 125kg
结局指标
主要结局
Prosthetic Limb User's Survey of Mobility (PLUS-M)
时间窗: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7
次要结局
- Locomotor capability index (LCI 5)(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- Fear of falling(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- AMP-PRO(At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay)
- EuroQol questionnaire (EQ-5D-5L)(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- 6 minute walking test(At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay)
- Reintegration to normal living index (RNLI)(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- Falls(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- Barthel Index(As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation))
- Timed Up and Go Test(At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay)
研究者
Johannes Schroeter
Director of Orthopaedic clinic
Median