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

NCT05551364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

ATLAS 2030 exoskeleton

Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases: 1. Telephone contact phase (1 session) 2. Inclusion Phase (1 session) 3. Signing of informed consent (1 session) 4. Initial Evaluation Phase (1 session) 5. Treatment Phase (1st part) (7 sessions) 6. Monthly Evaluation Phase (1 session) 7. Treatment Phase (2nd part) (7 sessions) 8. Monthly Evaluation Phase (1 session) 9. Treatment Phase (3rd part) (7 sessions) 10. Final Evaluation Phase and results (2 sessions)

Sponsors & Collaborators

  • Hospital Miguel Servet

    collaborator OTHER

  • ATADES

    collaborator UNKNOWN

  • Universidad de Zaragoza

    collaborator OTHER

  • Spanish National Research Council

    collaborator OTHER_GOV

  • Fundación Bobath Madrid

    collaborator UNKNOWN

  • ATENPACE Madrid

    collaborator UNKNOWN

  • MarsiBionics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2023-06-02
Completion
2023-08-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551364 on ClinicalTrials.gov