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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Acquired Brain Injury; Spinal Muscular Atrophy
• Intervention / Treatment: Device: EXPLORER

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPLORER; 8 sessions with the robotics gait device in their homes and natural environment for all participants	Device: EXPLORER; 8 sessions of use of the device in the home and the community of the participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	occurrence of any serious adverse event to the participant or the caregiver	through study completion, along 8 weeks
Falls prevalence	Number of falling events occurred from the participant or caregiver	through study completion, along 8 weeks
Skin integrity	Occurrence of any injury of the skin in the areas of contact and produced by the use of the device	through study completion, along 8 weeks
Pain (Visual Analogic Scale)	pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"	through study completion, along 8 weeks
Spasticity	spasticity measured by the Modified Ashworth Scale (MAS), scored from 0 (no spasticity) to 4 (affected part in rigid flexion or extension)	through study completion, along 8 weeks
Heart rate	measurement of heart rate	through study completion, along 8 weeks
Oxygen saturation	measurement of Oxygen saturation when medical prescription	through study completion, along 8 weeks
Donning and doffing time	Time to don and doff the device to each participant	through study completion, along 8 weeks
Number of steps	Number of steps taken provided by the device	through study completion, along 8 weeks
Walking time	Walking time provided by the device	through study completion, along 8 weeks
Interventions of the investigators	The number of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver	through study completion, along 8 weeks
Participant satisfaction	Satisfaction of the participant (caregiver) with the device measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. (QUEST 2.0), scored with a Likert type scale from 0 to 5, being 0 the lowest satisfaction and 5 the highest possible satisfaction with the device	at the end of the intervention, 8th week
Blood pressure	measurement of blood pressure	through study completion, along 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Analysis of the drop-out rate during the study period	at the end of the intervention, 8th week
Accessibility of the participant	Rate of the participants suitable to use the device	through study completion, along 8 weeks
Accessibility of the house	Rate of the houses suitable to use the device	through study completion, along 8 weeks
Accessibility of the exterior spaces	Rate of the exterior spaces that are suitable to use the device	through study completion, along 8 weeks

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Hospital Universitario 12 de Octubre; Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): August 17, 2024
• Study Completion (Actual): August 17, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: gait; rehabilitation; spinal muscular atrophy; cerebral palsy; robotics; acquired brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Brain Damage, Chronic; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Motor Neuron Disease; Cerebral Palsy; Brain Injuries; Muscular Atrophy; Atrophy; Muscular Atrophy, Spinal; Neuromuscular Diseases
• Other Study ID Numbers: EXP-I-US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No