Clinical trial NCT06538974: Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
Official title: Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Disorders
Gait Disorders, Neurologic
Neurodegenerative Diseases
Spinal Cord Injuries
Weakness, Muscle
Cerebrovascular Accident
Keywords: Hands-free Exoskeleton
Atalante X
Gait
Balance
Rehabilitation
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients presenting lower limb weakness and / or deficiencies, regardless of the underlying causes
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Function in Sitting Test
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
Secondary outcomes:
measure: 10-meter walk test
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Modified Clinical Test of Sensory Integration in Balance
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Timed Up and Go
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Functional Independence Measure
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: 6-minute walk test
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: A five-step clinical assessment of spasticity
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Biering-Sorensen test
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Muscle strength
timeFrame: At baseline, at 4 and 12 months, at 16 and 24 months
measure: Montreal Cognitive Assessment
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Adverse events monitoring
timeFrame: Through study completion, up to 24 months for each participant
measure: Modified Borg Rating of Perceived Exertion
timeFrame: At baseline, at 4 and 12 months, at 16 and 24 months
measure: System Usability Scale
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: General satisfaction questionnaire
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Specific acceptability
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Medical Outcomes Study Short Form 36
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Neurogenic bowel dysfunction score
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Qualiveen questionnaire
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: DN4
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Sensation assessment
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Hospital Anxiety and Depression Scale
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Goal Attainment Scaling
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: The Sport Injury Rehabilitation Adherence Scale
timeFrame: At baseline, at 4 and 12 months; at 16 and 24 months
measure: Number of performed exoskeleton sessions
timeFrame: Weekly, up to 24 months for each participant
measure: Duration of exoskeleton rehabilitation sessions
timeFrame: Weekly, up to 24 months for each participant
measure: The duration of verticalization during exoskeleton rehabilitation sessions
timeFrame: Weekly, up to 24 months for each participant
measure: Number of steps performed during exoskeleton sessions
timeFrame: Weekly, up to 24 months for each participant
measure: Level of device assistance during exoskeleton sessions
timeFrame: Weekly, up to 24 months for each participant
measure: Number of passive steps performed during exoskeleton sessions
timeFrame: Weekly, up to 24 months for each participant
measure: Number of active steps performed during exoskeleton sessions
timeFrame: Weekly, up to 24 months for each participant
Other outcomes:
Locations:
city: Paris
country: France
facility: Wandercraft
Study officials:
affiliation: Wandercraft
name: Rebecca Sauvagnac, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
citation: Eldar R, Kullmann L, Marincek C, Sekelj-Kauzlaric K, Svestkova O, Palat M. Rehabilitation medicine in countries of Central/Eastern Europe. Disabil Rehabil. 2008;30(2):134-41. doi: 10.1080/09638280701191776.
citation: Kamenov K, Mills JA, Chatterji S, Cieza A. Needs and unmet needs for rehabilitation services: a scoping review. Disabil Rehabil. 2019 May;41(10):1227-1237. doi: 10.1080/09638288.2017.1422036. Epub 2018 Jan 5.