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Completed

NCT Number: NCT05914818

Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease

The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.

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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Key information

Conditions

Cerebral Palsy Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Neuromuscular Diseases Neuromuscular Diseases in Children Trauma, Nervous System Wounds and Injuries

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación, Madrid, Spain

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About this study

Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton 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 V2 as a proof of concept.

A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Medical authorization for standing, gait training and weight bearing.
  • Informed consent signed by legal guardians.
  • Maximum user weight of 35 kg.
  • Hip width (between greater trochanteres) ≤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 ≤38 (EU)

Exclusion criteria

  • 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 flessum at the time of using the exoskeleton.
  • Necessity to walk with 15 of hip abduction.
  • Skin lesion on parts of the lower extremities that are in contact with the device.
  • Scheduled surgery scheduled during the study period.
  • History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
  • 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 or the inability to understand simple comands.
  • Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.

Treatment and study plan

EXPLORER V2

Device

4 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants

Primary outcomes

  1. Serious Adverse Events

    Time frame: through study completion, along 6 weeks

    occurrence of any serious adverse event to the participant or the caregiver

  2. Falls prevalence

    Time frame: through study completion, along 6 weeks

    Number of falling events ocurred from the participant or caregiver

  3. Skin integrity

    Time frame: through study completion, along 6 weeks

    Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton

  4. Pain (Visual Analogic Scale)

    Time frame: through study completion, along 6 weeks

    pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver

  5. Spasticity

    Time frame: through study completion, along 6 weeks

    spasticity measured by the Modified Ashworth Scale (MAS)

  6. Kinematic data during gait

    Time frame: Once, during the first session with the exoskeleton

    Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease

  7. Donning and doffing time

    Time frame: through study completion, along 6 weeks

    Time to don and doff the device to each participant

  8. Heart rate

    Time frame: through study completion, along 6 weeks

    measurement of heart rate when medical prescription

  9. Blood pressure

    Time frame: through study completion, along 6 weeks

    measurement of blood pressure when medical prescription

  10. Oxygen saturation

    Time frame: through study completion, along 6 weeks

    measurement of Oxygen saturation when medical prescription

  11. Participant satisfaction

    Time frame: at the end of the intervention, 6th week

    Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.

  12. Number of steps

    Time frame: through study completion, along 6 weeks

    Number of steps taken with the exoskeleton provided by the device

  13. Walking time

    Time frame: through study completion, along 6 weeks

    Walking time while using the exoskeleton provided by the device

  14. Interventions of the investigators

    Time frame: through study completion, along 6 weeks

    The amount 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

Secondary outcomes

  1. Acceptability

    Time frame: At the end of the study, 6th week

    Analysis of the drop-out rate during the study period

  2. Accesssibility of the participant

    Time frame: through study completion, along 6 weeks

    Rate of the participants suitable to use the device

  3. Accesssibility of the house

    Time frame: through study completion, along 6 weeks

    Rate of the houses suitable to use the device

  4. Accesssibility of the exterior spaces

    Time frame: through study completion, along 6 weeks

    Rate of the exterior spaces that are suitable to use the device

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Collaborators

  • Hospital General Universitario Gregorio Marañon
  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • National Research Council, Spain

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Nov 3, 2023

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.

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