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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05914818
• Other study ID #: EXP-P-VAL
• Status: Completed
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: August 2023
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy
• Neuromuscular Diseases
• Neuromuscular Diseases in Children

Intervention

Device:
• EXPLORER V2
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

Locations

Country	Name	City	State
Spain	Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
MarsiBionics	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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events	occurrence of any serious adverse event to the participant or the caregiver	through study completion, along 6 weeks
Primary	Falls prevalence	Number of falling events ocurred from the participant or caregiver	through study completion, along 6 weeks
Primary	Skin integrity	Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton	through study completion, along 6 weeks
Primary	Pain (Visual Analogic Scale)	pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver	through study completion, along 6 weeks
Primary	Spasticity	spasticity measured by the Modified Ashworth Scale (MAS)	through study completion, along 6 weeks
Primary	Kinematic data during gait	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	Once, during the first session with the exoskeleton
Primary	Donning and doffing time	Time to don and doff the device to each participant	through study completion, along 6 weeks
Primary	Heart rate	measurement of heart rate when medical prescription	through study completion, along 6 weeks
Primary	Blood pressure	measurement of blood pressure when medical prescription	through study completion, along 6 weeks
Primary	Oxygen saturation	measurement of Oxygen saturation when medical prescription	through study completion, along 6 weeks
Primary	Participant satisfaction	Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.	at the end of the intervention, 6th week
Primary	Number of steps	Number of steps taken with the exoskeleton provided by the device	through study completion, along 6 weeks
Primary	Walking time	Walking time while using the exoskeleton provided by the device	through study completion, along 6 weeks
Primary	Interventions of the investigators	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	through study completion, along 6 weeks
Secondary	Acceptability	Analysis of the drop-out rate during the study period	At the end of the study, 6th week
Secondary	Accesssibility of the participant	Rate of the participants suitable to use the device	through study completion, along 6 weeks
Secondary	Accesssibility of the house	Rate of the houses suitable to use the device	through study completion, along 6 weeks
Secondary	Accesssibility of the exterior spaces	Rate of the exterior spaces that are suitable to use the device	through study completion, along 6 weeks