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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurologic Disorder
• Intervention / Treatment: Other: Assessment

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients Neurological patients non-walking

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed by sonography	baseline and 6 weeks
Change from Baseline in the Mean filling pressure at 6 weeks	assessed by sonography	baseline and 6 weeks
Change from Baseline in the Mean Forced vital capacity at 6 weeks	FVD is assessed by spirometry	baseline and 6 weeks
Change from Baseline in the Mean serum calcium at 6 weeks		baseline and 6 weeks
Change from Baseline in the Mean serum creatine phosphokinase at 6 weeks	CPK	baseline and 6 weeks
Change from Baseline in the Mean serum parathormone at 6 weeks	PTH	baseline and 6 weeks
Change from Baseline in the Mean serum D vitamin at 6 weeks		baseline and 6 weeks
Change from Baseline in the Mean serum phosphatases alcalines at 6 weeks	PAL	baseline and 6 weeks
Change from Baseline in the Mean serum carboxy-terminal collagen crosslinks at 6 weeks	CTX	baseline and 6 weeks
Change from Baseline in the Mean serum Tartrate-resistant acid phosphatase 5b at 6 weeks	TRAP5b	baseline and 6 weeks
Change from Baseline in the Mean serum osteocalcin at 6 weeks		baseline and 6 weeks
Change from Baseline in the Mean urin calcium at 6 weeks	bone densitometry	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 bristol stool scale at 6 weeks		baseline and 6 weeks
Change from Baseline in the Mean voided volume 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 urinary symptom profile SCORE at 6 weeks	USP	baseline and 6 weeks
Change from Baseline in the Mean fatigue severity SCALE at 6 weeks	FSS	baseline and 6 weeks
Change from Baseline in the Mean trail making test A at 6 weeks	cognitive assessment	baseline and 6 weeks
Change from Baseline in the Mean fluence at 6 weeks	cognitive assessment	baseline and 6 weeks
Change from Baseline in the Mean span at 6 weeks	cognitive assessment	baseline and 6 weeks
Change from Baseline in the Mean Medical Outcome Study Short Form 12 at 6 weeks	quality of life assessment	baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2022-A0134142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No