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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167954
• Other study ID #: EXP-I-US
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: March 8, 2024

Study information

• Verified date: December 2023
• Source: MarsiBionics
• Contact: Eva Barquín Santos
• Phone: +34918711900
• Email: eva.barquin[@]marsibionics.com
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Atrophy
• Brain Injuries
• Cerebral Palsy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Neuromuscular Diseases
• Spinal Muscular Atrophy

Intervention

Device:
• EXPLORER
8 sessions of use of the device 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 (5)

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

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 8 weeks
Primary	Falls prevalence	Number of falling events occurred from the participant or caregiver	through study completion, along 8 weeks
Primary	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
Primary	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
Primary	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
Primary	Heart rate	measurement of heart rate	through study completion, along 8 weeks
Primary	Oxygen saturation	measurement of Oxygen saturation when medical prescription	through study completion, along 8 weeks
Primary	Donning and doffing time	Time to don and doff the device to each participant	through study completion, along 8 weeks
Primary	Number of steps	Number of steps taken provided by the device	through study completion, along 8 weeks
Primary	Walking time	Walking time provided by the device	through study completion, along 8 weeks
Primary	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
Primary	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
Primary	Blood pressure	measurement of blood pressure	through study completion, along 8 weeks
Secondary	Acceptability	Analysis of the drop-out rate during the study period	at the end of the intervention, 8th week
Secondary	Accessibility of the participant	Rate of the participants suitable to use the device	through study completion, along 8 weeks
Secondary	Accessibility of the house	Rate of the houses suitable to use the device	through study completion, along 8 weeks
Secondary	Accessibility of the exterior spaces	Rate of the exterior spaces that are suitable to use the device	through study completion, along 8 weeks