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

Neurologic Disorder Clinical Trial

— VERTEXO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05506306
• Other study ID #: 2022-A0134142
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2022
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

Other:
• Assessment
Clinical, biological and imagery before and after 6 weeks of using AtalanteTM exoskeleton

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Mean Hospital Anxiety and Depression scale at 6 weeks	HAD	baseline and 6 weeks
Primary	Change from Baseline in the Mean Sonographic Cardiac index at 6 weeks		baseline and 6 weeks
Primary	Change from Baseline in the Mean first second of forced expiration at 6 weeks	FEV1	baseline and 6 weeks
Primary	Change from Baseline in the Mean serum sclerostin at 6 weeks		D0 and D45
Primary	Change from Baseline in the Mean stool frequency at 6 weeks		baseline and 6 weeks
Primary	Change from Baseline in the Mean maximal urine flow rate at 6 weeks		D0 and D45
Primary	Change from Baseline in the Mean Trail Making Test B at 6 weeks	TMT-B	baseline and 6 weeks
Secondary	Change from Baseline in the Mean blood pressure at rest at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean stroke volume at 6 weeks	assessed by sonography	baseline and 6 weeks
Secondary	Change from Baseline in the Mean filling pressure at 6 weeks	assessed by sonography	baseline and 6 weeks
Secondary	Change from Baseline in the Mean Forced vital capacity at 6 weeks	FVD is assessed by spirometry	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum calcium at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum creatine phosphokinase at 6 weeks	CPK	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum parathormone at 6 weeks	PTH	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum D vitamin at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum phosphatases alcalines at 6 weeks	PAL	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum carboxy-terminal collagen crosslinks at 6 weeks	CTX	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum Tartrate-resistant acid phosphatase 5b at 6 weeks	TRAP5b	baseline and 6 weeks
Secondary	Change from Baseline in the Mean serum osteocalcin at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean urin calcium at 6 weeks	bone densitometry	baseline and 6 weeks
Secondary	Change from Baseline in the Mean bone densitometry at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean bristol stool scale at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean voided volume at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean post void residue at 6 weeks		baseline and 6 weeks
Secondary	Change from Baseline in the Mean urinary symptom profile SCORE at 6 weeks	USP	baseline and 6 weeks
Secondary	Change from Baseline in the Mean fatigue severity SCALE at 6 weeks	FSS	baseline and 6 weeks
Secondary	Change from Baseline in the Mean trail making test A at 6 weeks	cognitive assessment	baseline and 6 weeks
Secondary	Change from Baseline in the Mean fluence at 6 weeks	cognitive assessment	baseline and 6 weeks
Secondary	Change from Baseline in the Mean span at 6 weeks	cognitive assessment	baseline and 6 weeks
Secondary	Change from Baseline in the Mean Medical Outcome Study Short Form 12 at 6 weeks	quality of life assessment	baseline and 6 weeks