Motor DisordersALERTNCT06538974
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
A study testing Hands-free exoskeleton in people with Motor Disorders and Gait Disorders, Neurologic, run by Wandercraft at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases
- What is being tested?
- Hands-free exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2023to 2 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Wandercraft
Paris, 75004
Rebecca Sauvagnac, MD, +33 (0)1 79 35 31 09, rebecca.sauvagnac@wandercraft.health
Rebecca Sauvagnac, MD
About this study
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.
- Conditions
- Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases, Spinal Cord Injuries, Weakness, Muscle, Cerebrovascular Accident
- Being tested
- Hands-free exoskeleton
- Keywords
- Hands-free Exoskeleton, Atalante X, Gait, Balance, Rehabilitation
- Medical subject headings
- Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases, Spinal Cord Injuries, Muscle Weakness, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hands-free exoskeleton | Experimental | Not described Receives: Device: Hands-free exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, at 4 and 12 months; at 16 and 24 months
Secondary outcomes (29)
10-meter walk test
Gait speed during 10 meter walk
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline, at 4 and 12 months; at 16 and 24 months
Adverse events monitoring
Safety is monitored through adverse events occurrence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weekly, up to 24 months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start16 Feb 2023
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients presenting lower limb weakness and / or deficiencies, regardless of the underlying causes
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Sauvagnac, MD, Principal investigator, Wandercraft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538974
- Sponsor's protocol ID
- CIP005 ALERT
- Acronym
- ALERT
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33275908Eldar 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.
PubMed 17852214Kamenov 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.
PubMed 29303004
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
- ClinicalTrials.gov ID
- NCT06538974
- Acronym / sponsor ID
- ALERT / CIP005 ALERT
- Conditions
- Motor Disorders, Gait Disorders, Neurologic, Neurodegenerative Diseases, Spinal Cord Injuries, Weakness, Muscle, Cerebrovascular Accident
- Keywords
- Hands-free Exoskeleton, Atalante X, Gait, Balance, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients presenting lower limb weakness and / or deficiencies, regardless of the underlying causes
| Arm | Type | Receives |
|---|---|---|
| Hands-free exoskeleton | Experimental | Device: Hands-free exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-free exoskeletonDuring 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. | Device | Hands-free exoskeleton |
Primary outcome
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.
29 secondary outcomes
10-meter walk test
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Modified Clinical Test of Sensory Integration in Balance
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Timed Up and Go
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Functional Independence Measure
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
6-minute walk test
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
A five-step clinical assessment of spasticity
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Biering-Sorensen test
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Muscle strength
Time frame: At baseline, at 4 and 12 months, at 16 and 24 months
Montreal Cognitive Assessment
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Adverse events monitoring
Time frame: Through study completion, up to 24 months for each participant
Modified Borg Rating of Perceived Exertion
Time frame: At baseline, at 4 and 12 months, at 16 and 24 months
System Usability Scale
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
General satisfaction questionnaire
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Specific acceptability
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Medical Outcomes Study Short Form 36
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Neurogenic bowel dysfunction score
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Qualiveen questionnaire
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
DN4
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Sensation assessment
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Hospital Anxiety and Depression Scale
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Goal Attainment Scaling
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
The Sport Injury Rehabilitation Adherence Scale
Time frame: At baseline, at 4 and 12 months; at 16 and 24 months
Number of performed exoskeleton sessions
Time frame: Weekly, up to 24 months for each participant
Duration of exoskeleton rehabilitation sessions
Time frame: Weekly, up to 24 months for each participant
The duration of verticalization during exoskeleton rehabilitation sessions
Time frame: Weekly, up to 24 months for each participant
Number of steps performed during exoskeleton sessions
Time frame: Weekly, up to 24 months for each participant
Level of device assistance during exoskeleton sessions
Time frame: Weekly, up to 24 months for each participant
Number of passive steps performed during exoskeleton sessions
Time frame: Weekly, up to 24 months for each participant
Number of active steps performed during exoskeleton sessions
Time frame: Weekly, up to 24 months for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 33275908Cieza 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.
- Background: PubMed 17852214Eldar 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.
- Background: PubMed 29303004Kamenov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Sauvagnac, MD principal investigator
Wandercraft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-free exoskeleton in people with Motor Disorders and Gait Disorders, Neurologic, run by Wandercraft at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Sauvagnac, MD (+33 (0)1 79 35 31 09, rebecca.sauvagnac@wandercraft.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function in Sitting Test (time frame: At baseline, at 4 and 12 months; at 16 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538974, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.