Neuromuscular DiseasesNCT04813601
Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
A study testing ATLAS 2030 in people with Neuromuscular Diseases and Cerebral Palsy, run by MarsiBionics at 1 site in Spain.
Trial summary
The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Neuromuscular Diseases, Cerebral Palsy, SMA II
- What is being tested?
- ATLAS 2030
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2020to 24 Sep 2023
- 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
- Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
- Children between 3 and 14 years of age.
Who cannot join
- Weight> 35 kg
- Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) <23 cm or >38 cm for size M and from 31 cm to 40 cm for size L
- Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) <23 or >32 cm for size M and from or >39 cm for size L
- Distance between great trochanters <24 or >35 cm for size M and <25 cm or >35 cm for size L
- Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
- Spasticity measured with the Modified Ashworth Scale greater than or equal to 3 in the lower limbs
Show all 11Show fewer
- Scoliosis > 25° without the possibility of wearing a brace
- Skin alteration where direct contact between the patient's skin and the exoskeleton is not recommended
- Limitation of passive range of motion at the knee or hip joint > 20 degrees
- Osteoporosis that may induce a bone fracture when low intensity physical activity is performed
- Any other medical condition that may be a risk to the patient's safety and well-being in relation to low intensity physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estudio Piloto de Una Serie de Casos Para Evaluar el Efecto Rehabilitador Del Uso de un Exoesqueleto de Marcha en Pacientes Con patología Neuromuscular o parálisis Cerebral
The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool.
Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.
Read the detailed description
The objectives of the study are:
- Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation sessions.
- Objective 2:
- To assess the safety of a progressive treatment algorithm to achieve the safe progression of patients throughout the therapy
- To assess whether an improvement is achieved in parameters related to the physical rehabilitation of the patient using the exoskeleton, in respiratory capacity, self-perceived quality of life (physical and emotional well-being and self-esteem) as well as to assess the effectiveness of a psychological intervention to provide support in coping with the situation of using the device for the first time in those children who have not used it before.
The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:
Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.
Exclussion criteria: not fulfil the usage criteria of the device.
- Conditions
- Neuromuscular Diseases, Cerebral Palsy, SMA II
- Being tested
- ATLAS 2030
- Keywords
- Gait Exoskeleton, Robotics, Children, ATLAS 2030, Neuromuscular disease, Cerebral Palsy, Rehabilitation
- Medical subject headings
- Neuromuscular Diseases, Cerebral Palsy, Spinal Muscular Atrophies of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLAS 2030Device
Also called Robot Asissted Gait Training
The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Robot Asissted Gait Training | Experimental | The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton and will also have the technical supervision of personnel specialised in the handling of the laboratory and the robotic device. Receives: Device: ATLAS 2030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular balance
Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.
Measured: 1 month
Expanded Hammersmith Functional Motor Scale
Motor functionality measured for children with Spinal Muscular Atrophy
Measured: 3 months
Gross Motor Function Measure 88 (GMFM-88)
Motor functionality measured for children with Cerebral Palsy.
Measured: 3 months
Respiratory rate
Respiratory rate measured manually in breaths per minute using chronometer
Measured: 1 day
Heart rate
Measured in beats per minute using vital sign monitor
Measured: 1 day
Oxigen Saturation
Measured in %O2 using vital sign monitor
Measured: 1 day
Blood preasure
measured in mmHg with a sphyngomanometer
Measured: 1 day
Respiratory functional parameters
Measured by Spirometer (volumes measured in litres and pressures in mmHg)
Measured: 3 months
Quality of life assessment
Quality of life iof the children measured using the KINDL questionnaire.
Measured: 3 months
Joint range of motion
Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.
Measured: 1 month
Revised Upper Limb Module (RULM)
Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children
Measured: 3 months
Quality Upper Extremity Skill test (QUEST)
Upper limb quality of movement using QUEST scale for cerebral palsy children
Measured: 3 months
The Functional Independence Measure for Children (WeeFim)
WeeFim scale for CP children.
Measured: 3 months
Egen Klassifikation
Functional ability measured using EK2 scale for SMA
Measured: 3 months
Skin integrity
Skin alterations assessing their localization, size (centimeters), redness and temperature increase.
Measured: 1 day
Fatigue
Patient fatigue measured by Borg fatigue scale for children ages
Measured: 1 day
Pain assessment
Patient pain measured by EVA faces scale for children ages
Measured: 1 day
Peak Flow cough
Measured in litres per minute using a Peak flowmeter
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start9 Mar 2020
- Primary completion9 Mar 2021
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz, National Research Council, Spain
- Responsible party
- Sponsor
- Investigators
- Sandra Espinosa García, Medicine, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813601
- Sponsor's protocol ID
- ATLAS2030CLI-I
- Status last verified
- Oct 2023
- First submitted
- 15 Mar 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Piloto de Una Serie de Casos Para Evaluar el Efecto Rehabilitador Del Uso de un Exoesqueleto de Marcha en Pacientes Con patología Neuromuscular o parálisis Cerebral
- ClinicalTrials.gov ID
- NCT04813601
- Acronym / sponsor ID
- ATLAS2030CLI-I
- Conditions
- Neuromuscular Diseases, Cerebral Palsy, SMA II
- Keywords
- Gait Exoskeleton, Robotics, Children, ATLAS 2030, Neuromuscular disease, Cerebral Palsy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz, National Research Council, Spain
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 24 Mar 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.
The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool.
Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.
Detailed description
The objectives of the study are:
- Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation sessions.
- Objective 2:
- To assess the safety of a progressive treatment algorithm to achieve the safe progression of patients throughout the therapy
- To assess whether an improvement is achieved in parameters related to the physical rehabilitation of the patient using the exoskeleton, in respiratory capacity, self-perceived quality of life (physical and emotional well-being and self-esteem) as well as to assess the effectiveness of a psychological intervention to provide support in coping with the situation of using the device for the first time in those children who have not used it before.
The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:
Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.
Exclussion criteria: not fulfil the usage criteria of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Asissted Gait Training | Experimental | Device: ATLAS 2030The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton and will also have the technical supervision of personnel specialised in the handling of the laboratory and the robotic device. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
- Children between 3 and 14 years of age.
Key exclusion criteria (11 listed)
- Weight> 35 kg
- Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) <23 cm or >38 cm for size M and from 31 cm to 40 cm for size L
- Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) <23 or >32 cm for size M and from or >39 cm for size L
- Distance between great trochanters <24 or >35 cm for size M and <25 cm or >35 cm for size L
- Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
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 |
|---|---|---|
| ATLAS 2030Also: Robot Asissted Gait TrainingThe participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored. | Device | Robot Asissted Gait Training |
Primary outcome
Muscular balance
Time frame: 1 month
Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.
Expanded Hammersmith Functional Motor Scale
Time frame: 3 months
Motor functionality measured for children with Spinal Muscular Atrophy
Gross Motor Function Measure 88 (GMFM-88)
Time frame: 3 months
Motor functionality measured for children with Cerebral Palsy.
Respiratory rate
Time frame: 1 day
Respiratory rate measured manually in breaths per minute using chronometer
Heart rate
Time frame: 1 day
Measured in beats per minute using vital sign monitor
Oxigen Saturation
Time frame: 1 day
Measured in %O2 using vital sign monitor
Blood preasure
Time frame: 1 day
measured in mmHg with a sphyngomanometer
Respiratory functional parameters
Time frame: 3 months
Measured by Spirometer (volumes measured in litres and pressures in mmHg)
Quality of life assessment
Time frame: 3 months
Quality of life iof the children measured using the KINDL questionnaire.
Joint range of motion
Time frame: 1 month
Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.
Revised Upper Limb Module (RULM)
Time frame: 3 months
Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children
Quality Upper Extremity Skill test (QUEST)
Time frame: 3 months
Upper limb quality of movement using QUEST scale for cerebral palsy children
The Functional Independence Measure for Children (WeeFim)
Time frame: 3 months
WeeFim scale for CP children.
Egen Klassifikation
Time frame: 3 months
Functional ability measured using EK2 scale for SMA
Skin integrity
Time frame: 1 day
Skin alterations assessing their localization, size (centimeters), redness and temperature increase.
Fatigue
Time frame: 1 day
Patient fatigue measured by Borg fatigue scale for children ages
Pain assessment
Time frame: 1 day
Patient pain measured by EVA faces scale for children ages
Peak Flow cough
Time frame: 1 week
Measured in litres per minute using a Peak flowmeter
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 26 Oct 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Sandra Espinosa García, Medicine principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLAS 2030 in people with Neuromuscular Diseases and Cerebral Palsy, 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 2 inclusion and 11 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 26 Oct 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 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?
Muscular balance (time frame: 1 month). The study lists 18 primary outcomes in all. 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 26 Oct 2023.