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NCT06921551Completed

Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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 is: Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis? Participants will: * Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic * Have an evaluation (tests and questionnaires) every 3 months at the clinic

Status (registry)
Completed
Study type
Interventional
Enrollment
19 (actual)
First submitted
27 Mar 2025
Start date
7 Apr 2025
Primary completion date
29 May 2026
Lead sponsor
ABLE Human Motion S.L.
NCT number
NCT06921551

What you commit to

  • Study type: Interventional
  • Participants enrolled: 19
  • From 7 Apr 2025 to the primary completion date, 29 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
  • 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
  • Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
  • 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

Other

  • Significant osteoporosis that may increase the risk of fracture
  • 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
  • Skin integrity problems on the contact surfaces of the device or that would prevent sitting
  • 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

Who the study is looking for

  • 18 to 70 years old
  • Diagnosed with multiple sclerosis
  • Currently undergoing outpatient physical therapy treatment at the investigation site
  • Ability to give informed consent

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación Esclerosis Multiple Madrid (FEMM)
Coordinator of this site? Confirm its status
MadridSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.