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Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting

NCT06261541

CompletedNA

Sponsor: ABLE Human Motion S.L.

Conditions: Multiple Sclerosis

Interventions: ABLE Exoskeleton

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 of standing.
* Uncontrolled autonomic dysreflexia.
* Medically unstable
* 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.

Locations (1)

Madrid, Spain