NCT07050875

Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: ABLE Human Motion S.L. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting. The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

Detailed description

This is a pre-post, multicenter, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at the Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), and Fundación Step by Step Foundation, where a minimum of 15 participants (5 per center) are expected to be recruited within a period of 8 weeks. After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a baseline assessment without the medical device. Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 6 weeks. Sessions will be conducted 2 times per week. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.

Conditions

• Acquired Brain Injury (Including Stroke)

Interventions

Type	Name	Description
DEVICE	ABLE Exoskeleton	Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes.

Timeline

• Start date: 2025-06-30
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2025-07-03
• Last updated: 2026-01-27

Locations

3 sites across 1 country: Spain