Cerebral PalsyNCT04837157
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
A study testing Exoskeleton rehabilitation in people with Cerebral Palsy and SMA II, run by MarsiBionics at 1 site in Spain.
Trial summary
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Cerebral Palsy, SMA II, Neuromuscular Diseases
- What is being tested?
- Exoskeleton rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2020to 31 Jan 2021
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Maximum user weight of 35 kg
- Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
- Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
- Pelvis width (between greater trochanters) from 24 to 35 cm.
- Ability to achieve ankle dorsiflexion to 90˚
- 20º or more hip flessum.
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- 20º or more knee flessum.
- No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
- Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
- Patient being followed according to the recommended standards for his or her illness
- Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
- No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
- Score on the FAC scale between 1 and 4 points
- Not being able to walk without assistance
Who cannot join
- Patient's inability to follow simple instructions and/or communicate discomfort.
- Invasive or non-invasive daytime ventilation.
- Orthostatic hypotension.
- 20º or more hip flessum.
- 20º or more knee flessum
- Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
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- Severe skin injury to the lower extremities.
- Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
- History of fracture without trauma.
- History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
- Not receiving regular standing rehabilitation sessions.
- Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
- Refusal of the patient or legal guardian to include the child in the study.
- Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.
- Conditions
- Cerebral Palsy, SMA II, Neuromuscular Diseases
- Being tested
- Exoskeleton rehabilitation
- Keywords
- Exoskeleton, robot-assisted, physical therapy, ATLAS
- Medical subject headings
- Cerebral Palsy, Spinal Muscular Atrophies of Childhood, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton rehabilitationDevice
Also called ATLAS2030, ATLAS, robot-assisted therapy
The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks. Receives: Device: Exoskeleton rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as number of serious device adverse events
Presence of a serious device adverse events where the participant or therapist is involved
Measured: after each use of exoskeleton, for 5 weeks
Secondary outcomes (23)
Safety as presence of adverse events or adverse device events
Presence of a device adverse events where the participant or therapist is involved.
Measured: after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
Measured as time per event for at each therapy session.
Measured: after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
Measured as time to carry out the transfers
Measured: At each use of exoskeleton, for 5 weeks
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Measured as abandon ratio
Measured: At the end of the study, at the 5th week
Accessibility [number of potential participants in relation with the included participants]
Measured as relation between number of participants and number of potential participants which weren't recruited
Measured: At the end of the study, at the 5th week
Fall Prevalence [number of falls during the using of the device]
Number of falling events ocurred from the participant or therapist
Measured: During the use of the device, for 5 weeks
Skin integrity [number of skin injuries related to the device]
skin integrity measured as the number of skin injuries
Measured: before and after each use of exoskeleton, for 5 weeks
Pain [Wong-Baker FACES Pain Rating Scale]
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Measured: Before and after the use of the device, during 5 weeks
Fatigue [Borg Rating Scale of Perceived Exertion]
Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome.
Measured: Before and after the use of the device, during 5 weeks
Spasticity [Modified Ashworth Scale]
Spasticity registered before and after the use of the device
Measured: Before and after the use of the device, during 5 weeks
Heart rate [sphygmomanometer]
Number of heart bets per minute
Measured: Before and after the use of the device, during 5 weeks
Physical evaluation [number of physical injuries detected]
Physical Evaluation as presence of tissue damage
Measured: Before and after the use of the device, during 5 weeks
Muscle Strength [measured with Hand Held Dynamometer in N]
Muscle Strength measured at hip, knee and ankle muscles
Measured: At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Range of Movement
Measured: At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Functional Mobility with and without the device
Measured: At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Measurement of System's Usability measured by the therapist
Measured: At the end of the study, 5th week
User perception of the device [QUEST 2.0 and QUEST 2.1]
QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant
Measured: At the end of the study, 5th week
Distance covered walking [6MWT]
6MWT recorded using the device
Measured: At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Any device malfunction will be recorded
Measured: During the use of the device, for 5 weeks
Particpant's stability [Functional Reach Test]
Functional Reach Test
Measured: At the first day, 3rd week and 5th week
Systolic/Diastolic Pressure [sphygmomanometer]
Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)
Measured: Before and after the use of the device, during 5 weeks
Breath Rate [number of breaths per minute]
Number of breaths per minute
Measured: Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
SpO2 measured as %
Measured: Before and after the use of the device, during 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837157
- Sponsor's protocol ID
- ATLAS2030ENM-I
- Status last verified
- Apr 2021
- First submitted
- 3 Nov 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cumplido-Trasmonte C, Ramos-Rojas J, Delgado-Castillejo E, Garces-Castellote E, Puyuelo-Quintana G, Destarac-Eguizabal MA, Barquin-Santos E, Plaza-Flores A, Hernandez-Melero M, Gutierrez-Ayala A, Martinez-Moreno M, Garcia-Armada E. Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series. J Neuroeng Rehabil. 2022 Jul 19;19(1):75. doi: 10.1186/s12984-022-01055-x.
PubMed 35854321
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I
- ClinicalTrials.gov ID
- NCT04837157
- Acronym / sponsor ID
- ATLAS2030ENM-I
- Conditions
- Cerebral Palsy, SMA II, Neuromuscular Diseases
- Keywords
- Exoskeleton, robot-assisted, physical therapy, ATLAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 8 Apr 2021 (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.
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Exoskeleton rehabilitation9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Maximum user weight of 35 kg
- Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
- Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
- Pelvis width (between greater trochanters) from 24 to 35 cm.
- Ability to achieve ankle dorsiflexion to 90˚
Key exclusion criteria (14 listed)
- Patient's inability to follow simple instructions and/or communicate discomfort.
- Invasive or non-invasive daytime ventilation.
- Orthostatic hypotension.
- 20º or more hip flessum.
- 20º or more knee flessum
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 |
|---|---|---|
| Exoskeleton rehabilitationAlso: ATLAS2030, ATLAS, robot-assisted therapyThe participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session. | Device | Intervention Group |
Primary outcome
Safety as number of serious device adverse events
Time frame: after each use of exoskeleton, for 5 weeks
Presence of a serious device adverse events where the participant or therapist is involved
23 secondary outcomes
Safety as presence of adverse events or adverse device events
Time frame: after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
Time frame: after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
Time frame: At each use of exoskeleton, for 5 weeks
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Time frame: At the end of the study, at the 5th week
Accessibility [number of potential participants in relation with the included participants]
Time frame: At the end of the study, at the 5th week
Fall Prevalence [number of falls during the using of the device]
Time frame: During the use of the device, for 5 weeks
Skin integrity [number of skin injuries related to the device]
Time frame: before and after each use of exoskeleton, for 5 weeks
Pain [Wong-Baker FACES Pain Rating Scale]
Time frame: Before and after the use of the device, during 5 weeks
Fatigue [Borg Rating Scale of Perceived Exertion]
Time frame: Before and after the use of the device, during 5 weeks
Spasticity [Modified Ashworth Scale]
Time frame: Before and after the use of the device, during 5 weeks
Heart rate [sphygmomanometer]
Time frame: Before and after the use of the device, during 5 weeks
Physical evaluation [number of physical injuries detected]
Time frame: Before and after the use of the device, during 5 weeks
Muscle Strength [measured with Hand Held Dynamometer in N]
Time frame: At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Time frame: At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Time frame: At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Time frame: At the end of the study, 5th week
User perception of the device [QUEST 2.0 and QUEST 2.1]
Time frame: At the end of the study, 5th week
Distance covered walking [6MWT]
Time frame: At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Time frame: During the use of the device, for 5 weeks
Particpant's stability [Functional Reach Test]
Time frame: At the first day, 3rd week and 5th week
Systolic/Diastolic Pressure [sphygmomanometer]
Time frame: Before and after the use of the device, during 5 weeks
Breath Rate [number of breaths per minute]
Time frame: Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
Time frame: Before and after the use of the device, during 5 weeks
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 8 Apr 2021.
- Derived from this study: PubMed 35854321Cumplido-Trasmonte C, Ramos-Rojas J, Delgado-Castillejo E, Garces-Castellote E, Puyuelo-Quintana G, Destarac-Eguizabal MA, Barquin-Santos E, Plaza-Flores A, Hernandez-Melero M, Gutierrez-Ayala A, Martinez-Moreno M, Garcia-Armada E. Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series. J Neuroeng Rehabil. 2022 Jul 19;19(1):75. doi: 10.1186/s12984-022-01055-x.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton rehabilitation in people with Cerebral Palsy and SMA II, run by MarsiBionics at 1 site in Spain.
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 16 inclusion and 14 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 8 Apr 2021. 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 Spain. 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?
Safety as number of serious device adverse events (time frame: after each use of exoskeleton, for 5 weeks). 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 NCT04837157, which also lists 1 linked publication.
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 8 Apr 2021.