Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases

June 3, 2025 updated by: MarsiBionics

Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases

Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities. The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.

This study will involve testing the gait-assistance exoskeleton in healthy patients during the first phase, and in patients with stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), and muscular dystrophy (LM) during the second phase. The study will consist of two phases:

Phase 1: One visit with the device in healthy patients to assess the initial safety and comfort of the device.

Phase 2: A screening visit (S0) followed by two treatment visits with the device (V1-V2) in patients with ACV, DCA, EM, and LM to determine the effectiveness of the device in treating motor impairments caused by these conditions.

The goal of the study is to evaluate the safety and usability of the device in patients with ACV, DCA, EM, and LM, in order to identify potential benefits in improving gait, muscle strength, and overall functionality in this patient group.

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria related to the device characteristics:

  • Weight < 100 kg.
  • Hip width between 30 - 45 cm.
  • Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
  • Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
  • Patients must be able to follow simple instructions.
  • MAS < 3 in lower limbs.
  • EU shoe size between 36 and 45.
  • Absence of pathology affecting movement (only valid for phase 1 of the current study).

Inclusion criteria related to the study:

  • Age 18-85 years.
  • Diagnosis of stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), muscular dystrophy (LM), or cerebral palsy (PC).
  • Gait difficulty: those who require assistance to walk using technical aids, assistance, or supervision from others.
  • FAC score in participants with DCA, stroke, or MS < 4.
  • WISCI II score in participants with MD < 20.

Exclusion Criteria:

  • Spasticity (MAS) = 3 in lower limbs.
  • Skin alterations in the areas of contact with the device.
  • Planned surgical intervention during the study duration.
  • Two or more osteoporotic fractures in the lower limbs in the last 2 years.
  • Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).
  • Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
  • Psychiatric disorders that interfere with proper use of the device or participation in the study, such as impulsivity or inability to understand simple instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults EXPLORER
Two sessions with the robotic gait device in patients with neuromuscular diseases.
Device: Adults EXPLORER
Two sessions with the robotic gait device in patients with neuromuscular diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: Through study completion, an average of 1 month
Occurrence of any serious adverse event to the participant or the caregiver
Through study completion, an average of 1 month
Falls prevalence
Time Frame: Through study completion, an average of 1 month
Number of falling events occurred from the participant or caregiver
Through study completion, an average of 1 month
Heart Rate
Time Frame: Through study completion, an average of 1 month
Beats per minute
Through study completion, an average of 1 month
Skin integrity
Time Frame: Through study completion, an average of 1 month
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Through study completion, an average of 1 month
Device usage time
Time Frame: Through study completion, an average of 1 month
Time using the device
Through study completion, an average of 1 month
Level of Spasticity
Time Frame: Through study completion, an average of 1 month
Evaluation of spasticity with Modified Ahsworth Scale
Through study completion, an average of 1 month
Level of fatigue
Time Frame: Through study completion, an average of 1 month
Fatigue of both the participant and the therapist, Measured with the Borg scale
Through study completion, an average of 1 month
Donning and doffing time
Time Frame: Through study completion, an average of 1 month
Time to don and doff the device to each participant
Through study completion, an average of 1 month
Level of assistance a participant requires for walking
Time Frame: Through study completion, an average of 1 month
Measure with FAC scale
Through study completion, an average of 1 month
Walking ability of individuals with spinal cord injuries
Time Frame: Through study completion, an average of 1 month
Measure with WISCII (SCI) scale
Through study completion, an average of 1 month
TUG
Time Frame: Through study completion, an average of 1 month
The Time Up and Go test is used to assess a participant's mobility and balance
Through study completion, an average of 1 month
10MWT
Time Frame: Through study completion, an average of 1 month
The 10-Meter Walk Test is used to assess walking speed by measuring the time taken to walk 10 meters at a comfortable pace.
Through study completion, an average of 1 month
QUEST 2.0
Time Frame: at the end of the intervention, an average of 1 month
Using the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
at the end of the intervention, an average of 1 month
Blood Pressure
Time Frame: Through study completion, an average of 1 month
Measure in mmHg
Through study completion, an average of 1 month
Oxygen Saturation
Time Frame: Through study completion, an average of 1 month
It analyzes this absorption and calculates the SpO₂
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MarsiBionics

Collaborators

Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXP-A-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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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