Status:
ACTIVE_NOT_RECRUITING
Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
Lead Sponsor:
ABLE Human Motion S.L.
Collaborating Sponsors:
Fundación Esclerosis Múltiple Madrid (FEMM)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer ...
Eligibility Criteria
Inclusion
- 18 to 70 years old
- Diagnosed with multiple sclerosis
- Currently undergoing outpatient physical therapy treatment at the investigation site
- Ability to give informed consent
Exclusion
- Significant osteoporosis that may increase the risk of fracture
- Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
- Spinal instability (or spinal orthoses, unless authorized by a physician)
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes standing
- Uncontrolled autonomic dysreflexia
- Medical instability
- Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT)
- Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study
- Skin integrity problems on the contact surfaces of the device or that would prevent sitting
- Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
- Colostomy
- Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg
- Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device
- Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting
- Heterotopic ossification
- Known pregnancy or breastfeeding
- Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 7 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06921551
Start Date
April 7 2025
End Date
May 7 2026
Last Update
November 18 2025
Active Locations (1)
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1
Fundación Esclerosis Múltiple Madrid (FEMM)
Madrid, Madrid, Spain, 28029