Clinical trial NCT05506306: Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients
Official title: Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurologic Disorder
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients Neurological patients non-walking

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.


Eligibility criteria: Inclusion Criteria:

* inpatient in neurorehabilitation
* neuroligical lesion
* chair or bed bound more than 23h/24h and more than 2 weeks
* over 18 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean Sonographic Cardiac index at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean first second of forced expiration at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum sclerostin at 6 weeks
timeFrame: D0 and D45
measure: Change from Baseline in the Mean stool frequency at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean maximal urine flow rate at 6 weeks
timeFrame: D0 and D45
measure: Change from Baseline in the Mean Trail Making Test B at 6 weeks
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change from Baseline in the Mean blood pressure at rest at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean stroke volume at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean filling pressure at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean Forced vital capacity at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum calcium at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum creatine phosphokinase at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum parathormone at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum D vitamin at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum phosphatases alcalines at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum carboxy-terminal collagen crosslinks at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum Tartrate-resistant acid phosphatase 5b at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean serum osteocalcin at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean urin calcium at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean bone densitometry at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean bristol stool scale at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean voided volume at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean post void residue at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean urinary symptom profile SCORE at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean fatigue severity SCALE at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean trail making test A at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean fluence at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean span at 6 weeks
timeFrame: baseline and 6 weeks
measure: Change from Baseline in the Mean Medical Outcome Study Short Form 12 at 6 weeks
timeFrame: baseline and 6 weeks
Other outcomes:
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