Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy

September 26, 2024 updated by: MarsiBionics
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
      • Madrid, Spain, 28009
        • Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).

Description

Inclusion Criteria:

  • Medical authorization for standing, gait training and weight bearing.
  • Informed consent signed by legal guardians.
  • Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
  • Proper family acceptance and commitment level.
  • Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
  • Maximum user weight of 35 kg.
  • Hip width (between greater trochanteres) less than or equal to 35 cm.
  • Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
  • Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
  • Shoe size 27-33 (EU)

Exclusion Criteria:

  • More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
  • Intensive rehabilitation during the study.
  • Imposibility of the family to fulfill treatment calendar.
  • Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
  • More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
  • Necessity to walk with 10º of hip abduction.
  • Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
  • Severe skin lesion on parts of the lower extremities that are in contact with the device.
  • Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
  • History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
  • Severe rigid orthopedic deformities of the spine and/or lower limbs.
  • Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
  • Conditions that provoke exercise intolerance.
  • Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
  • Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Exoskeleton group
sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation
Device: ATLAS 2030
sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation
Control group
The children included in the control group will continue receiving their usual conventional therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88.

The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower.
At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Through study completion, along 1 year
changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity
Through study completion, along 1 year
Pediatric Quality of Life Inventory (PedsQLTM)
Time Frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life)
At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI)
Time Frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system
At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MarsiBionics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Gregorio Marañon
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Hospital Universitario 12 de Octubre
National Research Council, Spain
Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olga Arroyo Riaño, Hospital Universitario Gregorio Marañón
  • Principal Investigator: María Teresa Vara Arias, Hospital Infantil Universitario Niño Jesús
  • Principal Investigator: Ignacio Martínez Caballero, Hospital Infantil Universitario Niño Jesús
  • Principal Investigator: Sandra Espinosa García, Hospital Univsersitario La Paz
  • Principal Investigator: Sofía García de las Peñas, Hospital 12 de Octubre
  • Principal Investigator: Elena García Armada, National Research Council, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SERMAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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