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

NCT05506306 | Unknown

• 1 other identifier: 2022-A0134142
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks

  HAD

  baseline and 6 weeks

• Change from Baseline in the Mean Sonographic Cardiac index at 6 weeks

  baseline and 6 weeks

• Change from Baseline in the Mean first second of forced expiration at 6 weeks

  FEV1

  baseline and 6 weeks

• Change from Baseline in the Mean serum sclerostin at 6 weeks

  D0 and D45

• 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

• Change from Baseline in the Mean Trail Making Test B at 6 weeks

  TMT-B

  baseline and 6 weeks

Secondary Outcomes (23)

• Change from Baseline in the Mean blood pressure at rest 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 filling pressure 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 calcium at 6 weeks

  baseline and 6 weeks

Interventions

Assessment OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients Neurological patients non-walking

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henri Mondor University Hospital: lead

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hospital practicioner

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08