Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-08-17

Brief Summary

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The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.

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Detailed Description

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Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.

After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.

Conditions

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Cerebral Palsy Acquired Brain Injury Spinal Muscular Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EXPLORER

8 sessions with the robotics gait device in their homes and natural environment for all participants

Group Type EXPERIMENTAL

EXPLORER

Intervention Type DEVICE

8 sessions of use of the device in the home and the community of the participants

Interventions

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EXPLORER

8 sessions of use of the device in the home and the community of the participants

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Maximum user weight of 60 kg.
* Hip width (between greater trochanters) ≤40 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
* Shoe size ≤40 (EU)

Exclusion Criteria

* Medical contraindications for standing or walking.
* Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
* 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 non-reducible contractures at the time of using the exoskeleton.
* Necessity to walk with more than 5º of hip abduction.
* Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
* Lower length dysmetria that cannot be mitigated with a wedge under the foot.
* Skin lesion on parts of the lower extremities that are in contact with the device.
* History of fracture without trauma.
* Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness.
* Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No