Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wandercraft
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Function in Sitting Test
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
- •Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
- •Patient with a cardiac or respiratory contraindication to physical exertion, at 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.
Arms & Interventions
Hands-free exoskeleton
Intervention: Hands-free exoskeleton (Device)
Outcomes
Primary Outcomes
Function in Sitting Test
Time Frame: At baseline, at 4 and 12 months; at 16 and 24 months
The Function in Sitting Test consists of 14 items, each scored on a scale from 0 to 4, where 0 indicates the lowest ability and 4 represents normal sitting abilities. The maximum achievable score is 56, reflecting normal ability.
Secondary Outcomes
- Muscle strength(At baseline, at 4 and 12 months, at 16 and 24 months)
- Modified Clinical Test of Sensory Integration in Balance(At baseline, at 4 and 12 months; at 16 and 24 months)
- Timed Up and Go(At baseline, at 4 and 12 months; at 16 and 24 months)
- Functional Independence Measure(At baseline, at 4 and 12 months; at 16 and 24 months)
- 6-minute walk test(At baseline, at 4 and 12 months; at 16 and 24 months)
- A five-step clinical assessment of spasticity(At baseline, at 4 and 12 months; at 16 and 24 months)
- 10-meter walk test(At baseline, at 4 and 12 months; at 16 and 24 months)
- Montreal Cognitive Assessment(At baseline, at 4 and 12 months; at 16 and 24 months)
- Modified Borg Rating of Perceived Exertion(At baseline, at 4 and 12 months, at 16 and 24 months)
- Specific acceptability(At baseline, at 4 and 12 months; at 16 and 24 months)
- Biering-Sorensen test(At baseline, at 4 and 12 months; at 16 and 24 months)
- Neurogenic bowel dysfunction score(At baseline, at 4 and 12 months; at 16 and 24 months)
- Adverse events monitoring(Through study completion, up to 24 months for each participant)
- System Usability Scale(At baseline, at 4 and 12 months; at 16 and 24 months)
- General satisfaction questionnaire(At baseline, at 4 and 12 months; at 16 and 24 months)
- Number of steps performed during exoskeleton sessions(Weekly, up to 24 months for each participant)
- Level of device assistance during exoskeleton sessions(Weekly, up to 24 months for each participant)
- Number of passive steps performed during exoskeleton sessions(Weekly, up to 24 months for each participant)
- Medical Outcomes Study Short Form 36(At baseline, at 4 and 12 months; at 16 and 24 months)
- Sensation assessment(At baseline, at 4 and 12 months; at 16 and 24 months)
- The Sport Injury Rehabilitation Adherence Scale(At baseline, at 4 and 12 months; at 16 and 24 months)
- Number of active steps performed during exoskeleton sessions(Weekly, up to 24 months for each participant)
- Qualiveen questionnaire(At baseline, at 4 and 12 months; at 16 and 24 months)
- The duration of verticalization during exoskeleton rehabilitation sessions(Weekly, up to 24 months for each participant)
- DN4(At baseline, at 4 and 12 months; at 16 and 24 months)
- Hospital Anxiety and Depression Scale(At baseline, at 4 and 12 months; at 16 and 24 months)
- Goal Attainment Scaling(At baseline, at 4 and 12 months; at 16 and 24 months)
- Number of performed exoskeleton sessions(Weekly, up to 24 months for each participant)
- Duration of exoskeleton rehabilitation sessions(Weekly, up to 24 months for each participant)