Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
NCT06261541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-07-31
Summary
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.
Conditions
Interventions
- DEVICE
-
ABLE Exoskeleton
Participants with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks.
Sponsors & Collaborators
-
Fundación Esclerosis Múltiple Madrid (FEMM)
collaborator UNKNOWN -
ABLE Human Motion S.L.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-08
- Primary Completion
- 2024-07-30
- Completion
- 2024-07-30
Countries
- Spain
Study Locations
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