Using the ABLE Exoskeleton for rehabilitation in multiple sclerosis patients
Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
This study is testing whether using the ABLE Exoskeleton during rehabilitation can help people with multiple sclerosis improve their walking and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ABLE Human Motion S.L. Industry-sponsored |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06921551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with multiple sclerosis who are currently receiving outpatient physical therapy.
Not a fit: Patients with significant osteoporosis, unresolved fractures, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this could improve mobility and quality of life for patients with multiple sclerosis.
How similar studies have performed: While the use of exoskeletons in rehabilitation is a growing field, this specific application in multiple sclerosis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid
- Fundación Esclerosis Múltiple Madrid (FEMM) — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Almudena Chao Escuer
- Email: achao@femmadrid.org
- Phone: +34 913993245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.