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

NCT06167954 | Completed DMC

• 1 other identifier: EXP-I-US
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cerebral Palsy; Acquired Brain Injury; Spinal Muscular Atrophy

Keywords

cerebral palsy; acquired brain injury; spinal muscular atrophy; robotics; gait; rehabilitation

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (4)

• Acceptability

  at the end of the intervention, 8th week

• Accessibility of the participant

  through study completion, along 8 weeks

• Accessibility of the house

  through study completion, along 8 weeks

• Accessibility of the exterior spaces

  through study completion, along 8 weeks

Study Arms (1)

EXPLORER

EXPERIMENTAL

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

Device: EXPLORER

Interventions

EXPLORER DEVICE

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

EXPLORER

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (5)

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación

Madrid, 28009, Spain

Location

Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: December 4, 2023
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

ES (5)