Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inpatient, outpatient, and community-based) are insufficient to meet local population needs due to issues like long waiting times, lack of facilities, prioritization, funding, and accessibility.Patients with lower limb weaknesses, resulting from various conditions (for example stroke, traumatic brain injury, spinal cord injury and others) require long-term management and motivation for engagement, which are crucial for functional outcomes. This highlights the need for sustainable gait and balance rehabilitation. New technologies like exoskeletons have shown promising results in short-term inpatient programs, improving gait, balance, and quality of life, however, long-term follow-up data are still needed. The present clinical investigation is a national, prospective, open-label interventional trial, proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness and/or impairments in 100 participants. The rehabilitation program consists of at least one exoskeleton rehabilitation session per week. At the end of the first-year experimental phase, participants can continue for an additional year in the voluntary phase. The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor, cognitive, bowel, bladder functions, quality of life, and well-being. Assessments are conducted at baseline, after 4 and 12 months of exoskeleton rehabilitation, and at 16 and 24 months for participants in the voluntary phase.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient suffering from lower limb weaknesses and / or deficiencies regardless of the cause

• Adult patient ≥18 years old

• Patient able to read and write in French and who have signed an informed consent form

• Patient affiliated to a social security system.

Locations
Other Locations
France
Wandercraft
RECRUITING
Paris
Contact Information
Primary
Rebecca Sauvagnac, MD
rebecca.sauvagnac@wandercraft.health
+33 (0)1 79 35 31 09
Backup
Dijana Nuic, Ph.D
dijana.nuic@wandercraft.health
+33 (0)1 79 35 31 09
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2027-07-02
Participants
Target number of participants: 100
Treatments
Experimental: Hands-free exoskeleton
Related Therapeutic Areas
Sponsors
Leads: Wandercraft

This content was sourced from clinicaltrials.gov