Skip to main content
OpenTrials
Completed

NCT Number: NCT05551364

Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colegio de Educación Especial San Martín de Porres (ATADES), Zaragoza, Aragon, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATLAS 2030 Exoskeleton

Device

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 outcomes

  1. Gross Motor Function Classification System

    Time frame: Every month up to 3 months

    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)

  2. To quantify number of steps taken within the device

    Time frame: Every session up to 28 sessions

    Quantity of steps taken within the exoskeleton

  3. Changes in joint range of motion

    Time frame: Every session up to 28 sessions

    To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer

  4. Changes in spasticity

    Time frame: Every session up to 28 sessions

    To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale

  5. Changes in the Six-Minute Walking Test performance

    Time frame: Every month up to three months

    To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test

  6. Changes in the 10 Meters Walking Test performance

    Time frame: Every month up to three months

    To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test

  7. Changes in the time walked within the device

    Time frame: Three months

    To assess possible changes in the time walked within the device

  8. Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)

    Time frame: Every month up to three months

    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

  9. Changes in the Functional Independence Measure for Children (WeeFim)

    Time frame: Every month up to three months

    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

  10. Cerebral Palsy Quality of Life

    Time frame: Three months

    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 outcomes

  1. Safety of the ATLAS 2030

    Time frame: at study completion

    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.

  2. The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

    Time frame: at study completion

    To assess both professionals and patients´satisfaction when using the ATLAS 2030

  3. Acceptability

    Time frame: at study completion

    Measured through the dropout rate of the participants.

  4. Accessibility

    Time frame: at study completion

    Measure such as the relationship between the number of patients recruited and potential patients who were not recruited

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Collaborators

  • ATADES
  • ATENPACE Madrid
  • Fundación Bobath Madrid
  • Hospital Miguel Servet
  • Spanish National Research Council
  • Universidad de Zaragoza

Registry information

Official study title

Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.