Preliminary Feasibility Study of Rehabilitation by Robot "Coach" of Chronic Low Back Pain Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Average time of the daily physical activity
研究概览
简要总结
The objective of KERAAL technological project is to create a new intelligent robot which allows a humanoid robot to record then to show and to follow the progress of rehabilitation sessions proposed by a physiotherapist to a patient, the latter being able to practice without the physiotherapist. The final objective is to stimulate and increase the overseen time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements notably movements of the spine with 5 degrees of freedom associated to the several levels of the spine. It will allow to address the population included in the protocol. RCOOL study tries to validate this prototype device as tool of rehabilitation.
The main objective is the feasibility of the supervision by a humanoid robot of a succession of rehabilitation exercises.
RCOOL study is a randomized clinical trial checked under single-blind condition to compare two rehabilitation strategies, one with exercises executed by the patients and supervised by Poppy and the other one with usual rehabilitation protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Low back pain (more than 6 months)
- •Patient who has completed an outpatient rehabilitation program with at least 20 spine-centric sessions
- •Inclusion in a low back pain rehabilitation program in an inpatient our outpatient unit.
- •Adult between 18 and 70 years old
- •Patient affiliated to French social security system
- •Patient having signed an informed consent of participation for research
排除标准
- •Symptomatic low back pain (identified medical etiology)
- •Isolated sciatica, whatever the cause
- •Cruralgia
- •Chronic widespread pain
- •Age lower than 18 and higher than 70
- •Unfit of agreeing or refusing to participate in the study
- •Unstable medical situation preventing the continuous realization of a program of at least 4 weeks
结局指标
主要结局
Average time of the daily physical activity
时间窗: Day 0 to Week 4
Each therapist note the time of each physical activity session with the usually breaks. The time of kinesitherapy included the activity supervised by poppy will allow to evaluate the prototype device feasibility.
次要结局
- Visual Analog Scale (EVA) of lumbar pain(Day 0, Week 4 and Month 6)
- Dallas questionnaire(Day 0, Week 4 and Month 6)
- Fear Avoidance and Belief Questionnaire (FABQ)(Day 0, Week 4 and Month 6)
- Roland-Morris questionnaire(Day 0, Week 4 and Month 6)
- Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)(Day 0 to Week 4)
- Number of adverse events(Day 0 to Day 90)
- Acceptability questionnaire(Week 4 and Month 6)