Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks
研究概览
简要总结
Background and aim: Sustained bed rest impairs many bodily functions. Verticalization restores gravitational challenge and the use of several organs. The Atalante™ exoskeleton (Wandercraft) is the only self-balanced exoskeleton, which allows walking without canes. We assessed multi-tissular effects of mobile reverticalization using Atalante™ in neurological bed- or wheelchair-bound patients.
Methods: Observational cohort study. Inclusion criteria: bed- or wheelchair-bound for >2 weeks and <1 hour per day of stance, due to a central neurological disorder. Sessions with exoskeleton were 3/week, integrated in routine care. Data collected at baseline and after eight weeks (W8) included: cardiovascular (echocardiography, EKG, blood pressure lying and standing), pulmonary (spirometry), bone (densitometry, biochemical markers), bowels (daily stool frequency, Bristol Stool Scale), urinary (urinary flow, postmictional residual volume, urinary symptom profile questionnaire, USP), cognitive (trail making test, TMT-B), anxiety and depression (HAD), and quality of life (SF12).
Results will be presented at the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 in neurorehabilitation
- •neuroligical lesion
- •chair or bed bound more than 23h/24h and more than 2 weeks
- •over 18 years old
排除标准
- •spasticity over 3 on MAS
- •any porotic fracture
- •heel pressure sore
- •Height > 150 cms, > 190 cms
- •Weight < 30 kgs > 90 kgs
- •recent thoracic or abdominal surgery
- •pregnancy
- •range of motion aloud to use the exoskeleton
结局指标
主要结局
Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks
时间窗: baseline and 6 weeks
HAD
Change from Baseline in the Mean serum sclerostin at 6 weeks
时间窗: D0 and D45
Change from Baseline in the Mean Sonographic Cardiac index at 6 weeks
时间窗: baseline and 6 weeks
Change from Baseline in the Mean Trail Making Test B at 6 weeks
时间窗: baseline and 6 weeks
TMT-B
Change from Baseline in the Mean first second of forced expiration at 6 weeks
时间窗: baseline and 6 weeks
FEV1
Change from Baseline in the Mean stool frequency at 6 weeks
时间窗: baseline and 6 weeks
Change from Baseline in the Mean maximal urine flow rate at 6 weeks
时间窗: D0 and D45
次要结局
- Change from Baseline in the Mean blood pressure at rest at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum creatine phosphokinase at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean bristol stool scale at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean voided volume at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean filling pressure at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum D vitamin at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean stroke volume at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean Forced vital capacity at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum Tartrate-resistant acid phosphatase 5b at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean urin calcium at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum calcium at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum parathormone at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum phosphatases alcalines at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean fatigue severity SCALE at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean fluence at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean span at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum carboxy-terminal collagen crosslinks at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean serum osteocalcin at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean bone densitometry at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean post void residue at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean trail making test A at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean Medical Outcome Study Short Form 12 at 6 weeks(baseline and 6 weeks)
- Change from Baseline in the Mean urinary symptom profile SCORE at 6 weeks(baseline and 6 weeks)
研究者
ETIENNE SAVARD
hospital practicioner
Henri Mondor University Hospital