Safety and Usability of the EXPLORER Exoskeleton in Adult... | NCT06894160

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

NCT06894160

Sponsor

MarsiBionics

Status

Not yet recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

7Estimated

Phase

Not Applicable

Conditions

Neuromuscular Disorders

Interventions

Adults EXPLORER

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Jul 15, 2025Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

Mar 6, 2025

First Submission Date that Met QC Criteria

Mar 18, 2025

First Posted Date

Mar 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2025

Last Update Posted Date

Jun 4, 2025Actual

Name	Class
Hospital Universitario La Paz	OTHER

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults EXPLORER	Experimental	Two sessions with the robotic gait device in patients with neuromuscular diseases.	Device: Adults EXPLORER

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adults EXPLORER	Device	Two sessions with the robotic gait device in patients with neuromuscular diseases.	Adults EXPLORER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided