Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
NCT Number: NCT06538974
Acronym: ALERT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Motor Disorders|Gait Disorders, Neurologic|Neurodegenerative Diseases|Spinal Cord Injuries|Weakness, Muscle|Cerebrovascular Accident
Interventions: DEVICE: Hands-free exoskeleton
Sponsor: Wandercraft
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-16
Completion Date: 2027-07-02
Locations: Wandercraft, Paris, 75004, France

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.

Primary Outcome Measures: Function in Sitting Test, 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., At baseline, at 4 and 12 months; at 16 and 24 months
Secondary Outcome Measures: 10-meter walk test, Gait speed during 10 meter walk, At baseline, at 4 and 12 months; at 16 and 24 months|Modified Clinical Test of Sensory Integration in Balance, Modified Clinical Test of Sensory Integration in Balance test evaluates how different sensory inputs contribute to balance control by assessing balance tasks performed under different sensory conditions: eyes open, firm surface; eyes closed, firm surface; eyes open, foam surface; and eyes closed, foam surface. Scores are based on the time the participant can maintain balance (0-30 seconds for each task, with the maximum score being 120 seconds for all tasks, higher scores reflecting good sensory integration and balance control)., At baseline, at 4 and 12 months; at 16 and 24 months|Timed Up and Go, Timed Up and Go is a timed task where patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again. Based on established thresholds in the literature for various pathologies, the test helps determine if the participant is at risk of falling., At baseline, at 4 and 12 months; at 16 and 24 months|Functional Independence Measure, Functional Independence Measure scale score measures the level of disability and the amount of assistance required for an individual to perform activities of daily living. The total score ranges from 18 to 126, with higher scores indicating greater independence., At baseline, at 4 and 12 months; at 16 and 24 months|6-minute walk test, 6-minute walk test measures the walked distance during a 6 minutes' walk, thus assessing walking endurance and aerobic capacities. Results are compared to normative values based on population-specific references available in the literature., At baseline, at 4 and 12 months; at 16 and 24 months|A five-step clinical assessment of spasticity, A five-step clinical assessment of spasticity is used to assess adductor muscles, gluteus maximus, hamstrings, rectus femoris, gastrocnemius and soleus., At baseline, at 4 and 12 months; at 16 and 24 months|Biering-Sorensen test, Biering-Sorensen test measures isometric endurance of the trunk extensor muscles, higher times reflecting better endurance., At baseline, at 4 and 12 months; at 16 and 24 months|Muscle strength, Hip flexion, extension, abduction, adduction, knee flexion and extension, plantar flexion and extension muscle strength is assessed by using a dynamometer measure (expressed in Newton)., At baseline, at 4 and 12 months, at 16 and 24 months|Montreal Cognitive Assessment, Montreal Cognitive Assessment is a cognition assessment with scores ranging from 0 to 30, the latter signifying a normal cognitive function., At baseline, at 4 and 12 months; at 16 and 24 months|Adverse events monitoring, Safety is monitored through adverse events occurrence., Through study completion, up to 24 months for each participant|Modified Borg Rating of Perceived Exertion, Modified Borg Rating of Perceived Exertion measures a level of perceived effort and exertion, breathlessness and fatigue during physical activity with rating going from 0 - nothing at all to 10 - meaning almost maximal effort., At baseline, at 4 and 12 months, at 16 and 24 months|System Usability Scale, System Usability Scale measures usability of the exoskeleton training. The scores are from 0 to 100, scores above 72.5 reflecting good usability., At baseline, at 4 and 12 months; at 16 and 24 months|General satisfaction questionnaire, General satisfaction is assessed by 3-item questionnaire, assessing interest, satisfaction and level of discomfort. The score is comprised from 0 to 10, higher scores reflecting higher satisfaction following the assessed exoskeleton session., At baseline, at 4 and 12 months; at 16 and 24 months|Specific acceptability, Specific acceptability is assessed by five-item questionnaire evaluating participants feedback on post-session anxiety, motivation, safety, fatigue and pain.The score is comprised from 0 to 10, higher scores reflecting higher perceived specific acceptability following the assessed exoskeleton session., At baseline, at 4 and 12 months; at 16 and 24 months|Medical Outcomes Study Short Form 36, Medical Outcomes Study Short Form 36 (SF-36) assesses health related quality of life, by evaluating 8 subdimensions which concern physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional, and mental health. Two summary scores can be retrieved from the questionnaire: physical health and mental health. For people unable to walk, thus using wheelchair, additional three questions will be added from SF-36 walk-wheel questionnaire. Each domain is scored separately, and scores range from 0 to 100. The higher scores indicate better health status., At baseline, at 4 and 12 months; at 16 and 24 months|Neurogenic bowel dysfunction score, Neurogenic bowel dysfunction score measures bowel function, having the scores ranging from 0 to 47, scores above 14 signifying severe bowel dysfunction., At baseline, at 4 and 12 months; at 16 and 24 months|Qualiveen questionnaire, Qualiveen questionnaire assesses neurogenic bladder function related quality of life, each item being scored on a Likert type scale ranging from 0 to 4, assessing 4 areas: discomfort, constraints, fears, and the patient's experience. The score ranges from 0 to 4, higher scores indicating lower bladder function related quality of life., At baseline, at 4 and 12 months; at 16 and 24 months|DN4, DN4 questionnaire is used to identify neuropathic pain in patients. The score ranges from 0 to 10, a score of 4 or more is considered indicative of neuropathic pain., At baseline, at 4 and 12 months; at 16 and 24 months|Sensation assessment, 3-item sensation assessment with binary choice responses (yes or no) assessed by a physician regarding participants' capacity to perceive superficial sensation (touch awareness, pain perception) and proprioceptive sensation (kinesthetic awareness)., At baseline, at 4 and 12 months; at 16 and 24 months|Hospital Anxiety and Depression Scale, The Hospital Anxiety and Depression Scale is a 14-question instrument rated on a 4-point severity scale ranging between no impairment (0) and severe impairment (3). Hospital Anxiety and Depression Scale consists of two scales, one for anxiety, and one for depression, with a maximum score of 21 for each, respectively. Total scores from 8 to 10 for anxiety and depression are considered to be borderline abnormal and scores higher than 11 pathological., At baseline, at 4 and 12 months; at 16 and 24 months|Goal Attainment Scaling, Goal Attainment scaling tasks are individually identified to suit the subject, and the levels are individually set around their current and expected levels of performance. The progression is measured by identified levels that are as follows: Baseline score (-2), improved less than expected (-1), improved as expected (0), improved more than expected (+1) and improved much more than expected (+2)., At baseline, at 4 and 12 months; at 16 and 24 months|The Sport Injury Rehabilitation Adherence Scale, The Sport Injury Rehabilitation Adherence Scale measures clinically-based adherence to rehabilitation. The overall score is 15, higher numbers, representing better adherence to rehabilitation., At baseline, at 4 and 12 months; at 16 and 24 months|Number of performed exoskeleton sessions, The number of exoskeleton rehabilitation sessions performed will be tracked for each participant., Weekly, up to 24 months for each participant|Duration of exoskeleton rehabilitation sessions, The duration of exoskeleton rehabilitation sessions will be tracked for each participant, and will be expressed in minutes., Weekly, up to 24 months for each participant|The duration of verticalization during exoskeleton rehabilitation sessions, The time spent in an upright position (verticalization) during the exoskeleton rehabilitation sessions will be tracked for each participant, and expressed in minutes., Weekly, up to 24 months for each participant|Number of steps performed during exoskeleton sessions, The overall number of steps performed during the exoskeleton rehabilitation sessions will be tracked for each participant., Weekly, up to 24 months for each participant|Level of device assistance during exoskeleton sessions, The level of device assistance during the exoskeleton rehabilitation sessions will be tracked for each participant, and expressed as a percentage., Weekly, up to 24 months for each participant|Number of passive steps performed during exoskeleton sessions, The number of passive steps performed during the exoskeleton rehabilitation sessions will be tracked for each participant., Weekly, up to 24 months for each participant|Number of active steps performed during exoskeleton sessions, The number of active steps performed during the exoskeleton rehabilitation sessions will be tracked for each participant., Weekly, up to 24 months for each participant