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

NCT ID: NCT05506306

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-01

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.

Conditions

Neurologic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Assessment

Clinical, biological and imagery before and after 6 weeks of using AtalanteTM exoskeleton

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henri Mondor University Hospital

OTHER

Sponsor Role: lead

Responsible Party

ETIENNE SAVARD

hospital practicioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2022-A0134142

Identifier Type: -

Identifier Source: org_study_id