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

NCT06538974 · Wandercraft · Updated 6 Aug 2024

What is being tested
Hands-free exoskeleton
For
Motor Disorders; Gait Disorders, Neurologic; Neurodegenerative Diseases; Spinal Cord Injuries; Weakness, Muscle; Cerebrovascular Accident
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 100 people. The full rules are on the registry page.
Where
France
When
Starts or started 16 Feb 2023, ends 2 July 2027. Registered 6 Aug 2024.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT06538974

Sites

  • WandercraftParis, France