NCT06261541Completed
Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
Source: ClinicalTrials.gov · Last updated 31 Jul 2024
Brief summary (registry, in English)
The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 30 Jan 2024
- Start date
- 8 Apr 2024
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- ABLE Human Motion S.L.
- Diseases
- Multiple sclerosis
- NCT number
- NCT06261541
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 8 Apr 2024 to the primary completion date, 30 Jul 2024
- 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 of standing.
- Uncontrolled autonomic dysreflexia.
- Medically unstable
- 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 of age.
- Diagnosed with MS.
- Currently receiving treatment as an inpatient or outpatient at one of the investigational site.
- Ability to give informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Esclerosis Multiple Madrid (FEMM) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.