Complete Motor ParaplegiaM1-M2NCT05909774
Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
A study testing Test with Atalante exoskeleton in "continuous walk" type in people with Complete Motor Paraplegia, run by Wandercraft at 1 site in France.
Trial summary
The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a psychological impact on the quality of life, the risk of depression, and the difficulty of socio-professional… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Complete Motor Paraplegia
- What is being tested?
- Test with Atalante exoskeleton in "continuous walk" type
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2016to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Under 60 years of age
- Daily and autonomous use of wheelchair
- Paraplegia with level of injury between T6 and S1
- Patient unable to walk, neither during physiotherapy session nor in a daily routine
- Patient with cognitive capacities: able to understand oral and/or written instructions, as well as instructions given by demonstration
- Able to use their upper limbs
Show all 13Show fewer
- Can be verticalized
- Patient with a health care insurance
- Patient having given his/her written consent
- Joints amplitudes compatible with the use of the exoskeleton:
- Hip: Flexion>115°; Extension>15°; Abduction>17°; Adduction >10°; Medial rotation>35°; Internal rotation>10°
- Knee: Flexion>105°; Extension> -5°
- Ankle: Flexion>0°; Extension>9°; Supination>18°; Pronation>18°
Who cannot join
- Severe or complete deficiency of the upper limbs
- Bad control of the trunk
- Vestibular disorder (loss of balance, dizziness, …) when placed in the vertical position
- Upper limbs involuntary shivers and/or movements
- Pregnant women
- A lower or upper limb amputated
- Epilepsy
- Patient carrying an active implantable medical device
Trial locations and contacts
1 site in 1 country.
France1 site
CEREMH (Centre de ressources et d'innovation mobilité handicap)
Vélizy-Villacoublay, 78140
About this study
The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a psychological impact on the quality of life, the risk of depression, and the difficulty of socio-professional reintegration in a society that is not adapted to people with disabilities.
A motorized mechanical exoskeleton is an external device intended to compensate for a muscular or neurological deficiency enabling paraplegics to stand and walk again. The Atalante exoskeleton, designed by Wandercraft company allows patients to stand upright and walk without the aid of crutches.
This early study was the first clinical investigation of the Atalante exoskeleton performed early in the development. It was used to evaluate the device design concept with respect to initial clinical safety and device functionality and guided further device modifications.
Read the detailed description
The aim of this study was to test the use of the Atalante exoskeleton on 10 patients with complete motor paraplegia (ASIA A and B) with a level of injury between T6 and S1.
In this multi-centric clinical trial, patients were asked to perform between 1 and 2 days of training with Atalante exoskeleton including device training and evaluations (up to 9 hours of training and 3 hours of evaluation per patient).
The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).
Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test.
The secondary objectives focused on performance evaluation with the Atalante exoskeleton. The assessments performed were:
- Assessment of the superiority of the Atalante exoskeleton compared to the usual aid walking assistance used by the patient on the walking, verticalization (or sit-to-stand), static and dynamic balance ability
- Assessment of the static and dynamic postural stability of the subject with the Atalante exoskeleton by observation of center of pressure displacement and velocity
- Assessment of the perceived effort by the patient
- Assessment of perceived safety by the patient
- Assessment of the overall satisfaction of patients after using the exoskeleton
- Comparison of the two types of walk on walking ability, perceived effort, and safety
- Conditions
- Complete Motor Paraplegia
- Being tested
- Test with Atalante exoskeleton in "continuous walk" type
- Keywords
- exoskeleton, paraplegia, rehabilitation
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test with Atalante exoskeleton in "continuous walk" typeDevice
Also called Test with Atalante exoskeleton in "push and swing" walk type
The "continuous" walk is smoother and more physiologic than the "push and swing" walk
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton second | Experimental | This group first perform tests without Atalante exoskeleton and secondly with Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite. Receives: Device: Test with Atalante exoskeleton in "continuous walk" type |
| Exoskeleton first | Active comparator | This group first perform tests with Atalante exoskeleton and secondly without Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite. Receives: Device: Test with Atalante exoskeleton in "continuous walk" type |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).
Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test.
Measured: Day 2
Secondary outcomes (12)
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Evaluation of walking ability through a 10mWT
Measured: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Evaluation of verticalization ability through a success/failure test in a verticalization test (sit-to-stand movement)
Measured: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Evaluation of static balance through a success failure in a static standing test without support from the operator (3 x 30s in a static standing position)
Measured: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Evaluation of dynamic balance through a success/failure in a pointing test performed in a standing position without support from the operator (3 pointing sequences)
Measured: Day 2
Assessment of the static and dynamic postural stability
Static balance test with measurement of center of pressure displacement
Measured: Day 2
Assessment of the static and dynamic postural stability
Dynamic balance test with measurement of the average surface area under the (Center of Pressure position, Center of Pressure velocity) curve
Measured: Day 2
Assessment of the perceived effort by the patient
Evaluation of perceived effort by the patient through a Borg CR-10 scale
Measured: Day 2
Assessment of perceived safety by the patient
Evaluation of perceived safety by the patient through a 7-point Likert scale
Measured: Day 2
Assessment of the overall satisfaction of patients after using the exoskeleton
Assessment of the patient overall satisfaction through a 7-point Likert scale
Measured: Day 2
Comparison of the two types of walk
Comparison of the two types of walk on walking ability through the 10mWT
Measured: Day 2
Comparison of the two types of walk
Comparison of the two types of walk on perceived effort during the 10mWT through a Borg CR-10 Scale
Measured: Day 2
Comparison of the two types of walk
Comparison of the two types of walk on perceived safety during the 10mWT through a 7-point Likert scale
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 Dec 2016
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Motor ParaplegiaStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multicentric, comparative, randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wandercraft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Albert, MD, Principal investigator, COS CMPR de Bobigny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909774
- Sponsor's protocol ID
- 2016-A01257-44
- Acronym
- M1-M2
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
- ClinicalTrials.gov ID
- NCT05909774
- Acronym / sponsor ID
- M1-M2 / 2016-A01257-44
- Conditions
- Complete Motor Paraplegia
- Keywords
- exoskeleton, paraplegia, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- WandercraftIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 18 Jun 2023 (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.
The loss of standing and walking capabilities in a paraplegic person is most often the result of damage to the spinal cord, either traumatic (accidental) or pathological and has both a somatic and a psychological impact on the quality of life, the risk of depression, and the difficulty of socio-professional reintegration in a society that is not adapted to people with disabilities.
A motorized mechanical exoskeleton is an external device intended to compensate for a muscular or neurological deficiency enabling paraplegics to stand and walk again. The Atalante exoskeleton, designed by Wandercraft company allows patients to stand upright and walk without the aid of crutches.
This early study was the first clinical investigation of the Atalante exoskeleton performed early in the development. It was used to evaluate the device design concept with respect to initial clinical safety and device functionality and guided further device modifications.
Detailed description
The aim of this study was to test the use of the Atalante exoskeleton on 10 patients with complete motor paraplegia (ASIA A and B) with a level of injury between T6 and S1.
In this multi-centric clinical trial, patients were asked to perform between 1 and 2 days of training with Atalante exoskeleton including device training and evaluations (up to 9 hours of training and 3 hours of evaluation per patient).
The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).
Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test.
The secondary objectives focused on performance evaluation with the Atalante exoskeleton. The assessments performed were:
- Assessment of the superiority of the Atalante exoskeleton compared to the usual aid walking assistance used by the patient on the walking, verticalization (or sit-to-stand), static and dynamic balance ability
- Assessment of the static and dynamic postural stability of the subject with the Atalante exoskeleton by observation of center of pressure displacement and velocity
- Assessment of the perceived effort by the patient
- Assessment of perceived safety by the patient
- Assessment of the overall satisfaction of patients after using the exoskeleton
- Comparison of the two types of walk on walking ability, perceived effort, and safety
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, comparative, randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton second | Experimental | Device: Test with Atalante exoskeleton in "continuous walk" typeThis group first perform tests without Atalante exoskeleton and secondly with Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite. |
| Exoskeleton first | Active comparator | Device: Test with Atalante exoskeleton in "continuous walk" typeThis group first perform tests with Atalante exoskeleton and secondly without Atalante exoskeleton. A second randomization is performed inside each group, with half of the patients first performing walk test with the "Continuous" walk and then with the "Push \& Swing" walk, and the other half doing the opposite. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Under 60 years of age
- Daily and autonomous use of wheelchair
- Paraplegia with level of injury between T6 and S1
- Patient unable to walk, neither during physiotherapy session nor in a daily routine
- Patient with cognitive capacities: able to understand oral and/or written instructions, as well as instructions given by demonstration
Key exclusion criteria (8 listed)
- Severe or complete deficiency of the upper limbs
- Bad control of the trunk
- Vestibular disorder (loss of balance, dizziness, …) when placed in the vertical position
- Upper limbs involuntary shivers and/or movements
- Pregnant women
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 |
|---|---|---|
| Test with Atalante exoskeleton in "continuous walk" typeAlso: Test with Atalante exoskeleton in "push and swing" walk typeThe "continuous" walk is smoother and more physiologic than the "push and swing" walk | Device | Exoskeleton first, Exoskeleton second |
Primary outcome
The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT).
Time frame: Day 2
Within-group differences between the Atalante exoskeleton and the usual walking aid used by the patient in the success rate of the 10MWT were compared by a McNemar test.
12 secondary outcomes
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Time frame: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Time frame: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Time frame: Day 2
Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
Time frame: Day 2
Assessment of the static and dynamic postural stability
Time frame: Day 2
Assessment of the static and dynamic postural stability
Time frame: Day 2
Assessment of the perceived effort by the patient
Time frame: Day 2
Assessment of perceived safety by the patient
Time frame: Day 2
Assessment of the overall satisfaction of patients after using the exoskeleton
Time frame: Day 2
Comparison of the two types of walk
Time frame: Day 2
Comparison of the two types of walk
Time frame: Day 2
Comparison of the two types of walk
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Complete Motor Paraplegia
Recruiting
Research on Wireless Brain Implant System for General Control of External Devices
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
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. This study is not recruiting at the moment.
Thierry Albert, MD principal investigator
COS CMPR de Bobigny
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test with Atalante exoskeleton in "continuous walk" type in people with Complete Motor Paraplegia, 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 13 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study was to assess patients' ability to walk straight- for 10 meters with the Atalante exoskeleton during 10-meters walk test (10MWT). (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.