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Multitissular Effect of Vertical Mobilization Using the Exoskeleton AtalanteTM in Neurological Chair- or Bed-bound Patients (VERTEXO)

H

Henri Mondor University Hospital

Status

Not yet enrolling

Conditions

Neurologic Disorder

Treatments

Other: Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT05506306
2022-A0134142

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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