An interventional study of Hands-free exoskeleton in Motor Disorders, Gait Disorders, Neurologic and Neurodegenerative Diseases, sponsored by Wandercraft. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Wandercraft · Not applicable, Interventional, and Treatment
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.
73 studies on the registry are indexed under Motor Disorders; 24 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 52 interventional studies indexed under Motor Disorders.
Browse Motor Disorders studies →Wandercraft is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hands-free exoskeleton
During the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X. The additional voluntary year follows the same design. During sessions with the exoskeleton, the patients will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.
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.
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
10-meter walk test
Gait speed during 10 meter walk
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Adverse events monitoring
Safety is monitored through adverse events occurrence.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly, up to 24 months for each participant
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Jul 2027, 52 months after the start.
Of 34 interventional studies with no phase under Motor Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's planned 52 months is above that.
How these figures are worked out, and which studies are left out of them.
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