Long-term exoskeleton rehabilitation for adults with lower limb weakness
Tests a hands-free exoskeleton for weak legs in adults, over one year of outpatient sessions.
Key facts
- Who runs it
- Wandercraft
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 16 Feb 2023
- Expected to end
- 2 Jul 2027
- Type of study
- Interventional
- Treatments tested
- Hands-free exoskeleton
- Record updated
- 6 August 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with weak lower limbs or lower limb impairments, from any cause. They would do a 12-month outpatient rehabilitation program with the Atalante X exoskeleton.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Lower limb weakness and/or impairments, regardless of the cause. No severe spasticity (a score of 4 on the modified Ashworth scale).
Main reasons for not taking part
- Severe spasticity of the thigh and calf muscles (score of 4 on the modified Ashworth scale)
- Pregnant women
- History of osteoporotic fracture, or a condition or treatment causing secondary osteoporosis
- Pressure ulcer of Grade I or higher where the exoskeleton touches the body
- Heart or lung problem that makes physical exertion unsafe, at the doctor's discretion
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis
- Pressure Ulcer of Grade I or higher according to the NPUAP International Pressure Ulcer Classification System- EPUAP, in areas of contact with the Atalante X system
- Patient with a cardiac or respiratory contraindication to physical exertion, at discretion of the physician
- Individual with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score of 4 on the modified Ashworth scale
- Pregnant woman
- Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician
- Patient unable to deliver his/her consent
- Patient under legal protection
- Patient participating at the same time in another study
- Patients with morphological contraindications to the use of the Atalante X exoskeleton (as per user's manual) with exceptions as follows: knee flessum of 20° authorized if sensibility is present; equinus of the ankle of 20° allowed regardless of presence or absence of sensibility, hip flessum of 20° allowed regardless of presence or absence of sensibility
Where in France
- WandercraftParis, FranceContact: Rebecca Sauvagnac, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Hands-free exoskeletonTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
- Plain-language title
- Long-term exoskeleton rehabilitation for adults with lower limb weaknessGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 August 2024