Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients
- Conditions
- Neurologic Disorder
- Registration Number
- NCT05506306
- Lead Sponsor
- Henri Mondor University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- inpatient in neurorehabilitation
- neuroligical lesion
- chair or bed bound more than 23h/24h and more than 2 weeks
- over 18 years old
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks baseline and 6 weeks HAD
Change from Baseline in the Mean serum sclerostin at 6 weeks D0 and D45 Change from Baseline in the Mean Sonographic Cardiac index at 6 weeks baseline and 6 weeks Change from Baseline in the Mean Trail Making Test B at 6 weeks baseline and 6 weeks TMT-B
Change from Baseline in the Mean first second of forced expiration at 6 weeks baseline and 6 weeks FEV1
Change from Baseline in the Mean stool frequency at 6 weeks baseline and 6 weeks Change from Baseline in the Mean maximal urine flow rate at 6 weeks D0 and D45
- Secondary Outcome Measures
Name Time Method 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 CPK
Change from Baseline in the Mean bristol stool scale at 6 weeks baseline and 6 weeks Change from Baseline in the Mean filling pressure at 6 weeks baseline and 6 weeks assessed by sonography
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 assessed by sonography
Change from Baseline in the Mean Forced vital capacity at 6 weeks baseline and 6 weeks FVD is assessed by spirometry
Change from Baseline in the Mean serum Tartrate-resistant acid phosphatase 5b at 6 weeks baseline and 6 weeks TRAP5b
Change from Baseline in the Mean urin calcium at 6 weeks baseline and 6 weeks bone densitometry
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 PTH
Change from Baseline in the Mean serum phosphatases alcalines at 6 weeks baseline and 6 weeks PAL
Change from Baseline in the Mean fatigue severity SCALE at 6 weeks baseline and 6 weeks FSS
Change from Baseline in the Mean fluence at 6 weeks baseline and 6 weeks cognitive assessment
Change from Baseline in the Mean span at 6 weeks baseline and 6 weeks cognitive assessment
Change from Baseline in the Mean serum carboxy-terminal collagen crosslinks at 6 weeks baseline and 6 weeks CTX
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 cognitive assessment
Change from Baseline in the Mean Medical Outcome Study Short Form 12 at 6 weeks baseline and 6 weeks quality of life assessment
Change from Baseline in the Mean urinary symptom profile SCORE at 6 weeks baseline and 6 weeks USP
Change from Baseline in the Mean voided volume at 6 weeks baseline and 6 weeks