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

NCT06894160 | Not Yet Recruiting DMC

• 1 other identifier: EXP-A-US
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Disorders

Keywords

gait; robotics; neuromuscular disorders; rehabilitation

Outcome Measures

Primary Outcomes (15)

• Serious Adverse Events

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

  Through study completion, an average of 1 month

• Falls prevalence

  Number of falling events occurred from the participant or caregiver

  Through study completion, an average of 1 month

• Heart Rate

  Beats per minute

  Through study completion, an average of 1 month

• 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, an average of 1 month

• Device usage time

  Time using the device

  Through study completion, an average of 1 month

• Level of Spasticity

  Evaluation of spasticity with Modified Ahsworth Scale

  Through study completion, an average of 1 month

• Level of fatigue

  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 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

  Measure with FAC scale

  Through study completion, an average of 1 month

• Walking ability of individuals with spinal cord injuries

  Measure with WISCII (SCI) scale

  Through study completion, an average of 1 month

• TUG

  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

  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

  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

  Measure in mmHg

  Through study completion, an average of 1 month

• Oxygen Saturation

  It analyzes this absorption and calculates the SpO₂

  Through study completion, an average of 1 month

Study Arms (1)

Adults EXPLORER

EXPERIMENTAL

Two sessions with the robotic gait device in patients with neuromuscular diseases.

Device: Adults EXPLORER

Interventions

Adults EXPLORER DEVICE

Two sessions with the robotic gait device in patients with neuromuscular diseases.

Adults EXPLORER

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Universitario La Paz: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Carlos Cumplido Trasmonte

CONTACT

+34918711900; carlos.cumplido@marsibionics.com

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: March 6, 2025
• First Posted: March 25, 2025
• Study Start: July 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-03

Locations

ES (1)