Using the ABLE Exoskeleton for rehabilitation in multiple sclerosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program for individuals with multiple sclerosis. Participants will engage in weekly 60-minute gait training sessions using the exoskeleton for a duration of 12 months, alongside evaluations every three months to assess their physical and psychosocial health. The primary aim is to determine if this innovative approach can enhance the overall well-being of those affected by multiple sclerosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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 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

Where it's running

• Fundación Esclerosis Múltiple Madrid (FEMM)
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Almudena Chao Escuer
• Email: achao@femmadrid.org
• Phone: +34 913993245

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.