Back to resultsUsability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ATLAS 2030 exoskeleton
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring exoskeleton, paediatric, gait, robotic gait assited training
Eligibility Criteria
Inclusion Criteria:
- Medical authorization to for standing, gait training and weight bearing.
- Maximum user weight of 35 kg.
- 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.
- Hip width (between greater trochanteres) less than or equal to 35 cm.
- Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
- Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy affecting the ability to walk.
- Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
- Patient in follow-up according to the normal standards recommended for his illness.
Exclusion Criteria:
- More than 20º of hip flessum at the time of using the exoskeleton.
- More than 20º of knee flessum at the time of using the exoskeleton.
- 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.
- 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 patient's skin.
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
Sites / Locations
- Colegio de Educación Especial San Martín de Porres (ATADES)
- ATENPACE
- Centre for Automation and Robotics, Marsi Care
- Fundación Bobath
- Hospital Universitario Miguel Servet
- Universidad de Zaragoza
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional Treatment
Treatment with the ATLAS 2030 Exoskeleton
Arm Description
The children will continue with their current rehabilitation program
The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months
Outcomes
Primary Outcome Measures
Gross Motor Function Classification System
To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility)
To quantify number of steps taken within the device
Quantity of steps taken within the exoskeleton
Changes in joint range of motion
To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Changes in spasticity
To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Changes in the Six-Minute Walking Test performance
To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Changes in the 10 Meters Walking Test performance
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Changes in the time walked within the device
To assess possible changes in the time walked within the device
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better
Changes in the Functional Independence Measure for Children (WeeFim)
To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant
Cerebral Palsy Quality of Life
To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life
Secondary Outcome Measures
Safety of the ATLAS 2030
Measured as the occurrence of adverse events such as onset of pain, fatigue, presence of falls or alteration of the integrity of the user's skin, by the use of the device.
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
To assess both professionals and patients´satisfaction when using the ATLAS 2030
Acceptability
Measured through the dropout rate of the participants.
Accessibility
Measure such as the relationship between the number of patients recruited and potential patients who were not recruited
Full Information
NCT ID
NCT05551364
First Posted
September 2, 2022
Last Updated
June 2, 2023
Sponsor
MarsiBionics
Collaborators
Hospital Miguel Servet, ATADES, Universidad de Zaragoza, Spanish National Research Council, Fundación Bobath Madrid, ATENPACE Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05551364
Brief Title
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
Official Title
Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
Hospital Miguel Servet, ATADES, Universidad de Zaragoza, Spanish National Research Council, Fundación Bobath Madrid, ATENPACE Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
exoskeleton, paediatric, gait, robotic gait assited training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Treatment
Arm Type
No Intervention
Arm Description
The children will continue with their current rehabilitation program
Arm Title
Treatment with the ATLAS 2030 Exoskeleton
Arm Type
Experimental
Arm Description
The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months
Intervention Type
Device
Intervention Name(s)
ATLAS 2030 exoskeleton
Intervention Description
Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases:
Telephone contact phase (1 session)
Inclusion Phase (1 session)
Signing of informed consent (1 session)
Initial Evaluation Phase (1 session)
Treatment Phase (1st part) (7 sessions)
Monthly Evaluation Phase (1 session)
Treatment Phase (2nd part) (7 sessions)
Monthly Evaluation Phase (1 session)
Treatment Phase (3rd part) (7 sessions)
Final Evaluation Phase and results (2 sessions)
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System
Description
To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility)
Time Frame
Every month up to 3 months
Title
To quantify number of steps taken within the device
Description
Quantity of steps taken within the exoskeleton
Time Frame
Every session up to 28 sessions
Title
Changes in joint range of motion
Description
To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Time Frame
Every session up to 28 sessions
Title
Changes in spasticity
Description
To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Time Frame
Every session up to 28 sessions
Title
Changes in the Six-Minute Walking Test performance
Description
To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Time Frame
Every month up to three months
Title
Changes in the 10 Meters Walking Test performance
Description
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Time Frame
Every month up to three months
Title
Changes in the time walked within the device
Description
To assess possible changes in the time walked within the device
Time Frame
Three months
Title
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
Description
To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better
Time Frame
Every month up to three months
Title
Changes in the Functional Independence Measure for Children (WeeFim)
Description
To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant
Time Frame
Every month up to three months
Title
Cerebral Palsy Quality of Life
Description
To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Safety of the ATLAS 2030
Description
Measured as the occurrence of adverse events such as onset of pain, fatigue, presence of falls or alteration of the integrity of the user's skin, by the use of the device.
Time Frame
at study completion
Title
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Description
To assess both professionals and patients´satisfaction when using the ATLAS 2030
Time Frame
at study completion
Title
Acceptability
Description
Measured through the dropout rate of the participants.
Time Frame
at study completion
Title
Accessibility
Description
Measure such as the relationship between the number of patients recruited and potential patients who were not recruited
Time Frame
at study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medical authorization to for standing, gait training and weight bearing.
Maximum user weight of 35 kg.
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.
Hip width (between greater trochanteres) less than or equal to 35 cm.
Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
Informed consent signed by legal guardians.
Confirmed diagnosis of cerebral palsy affecting the ability to walk.
Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
Patient in follow-up according to the normal standards recommended for his illness.
Exclusion Criteria:
More than 20º of hip flessum at the time of using the exoskeleton.
More than 20º of knee flessum at the time of using the exoskeleton.
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.
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 patient's skin.
Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
Facility Information:
Facility Name
Colegio de Educación Especial San Martín de Porres (ATADES)
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
35012
Country
Spain
Facility Name
ATENPACE
City
Madrid
Country
Spain
Facility Name
Centre for Automation and Robotics, Marsi Care
City
Madrid
Country
Spain
Facility Name
Fundación Bobath
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Universidad de Zaragoza
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
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