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

NCT06538974 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

  • Motor Disorders
  • Gait Disorders, Neurologic
  • Neurodegenerative Diseases
  • Spinal Cord Injuries
  • Weakness, Muscle
  • Cerebrovascular Accident

Interventions

DEVICE

Hands-free exoskeleton

During the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X. The additional voluntary year follows the same design. During sessions with the exoskeleton, the patients will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.

Sponsors & Collaborators

  • Wandercraft

    lead INDUSTRY

Principal Investigators

  • Rebecca Sauvagnac, MD · Wandercraft

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2027-07-02
Completion
2027-07-02

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538974 on ClinicalTrials.gov