NCT06261541

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: ABLE Human Motion S.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a pre-post, single-center, quasi-experimental study with an estimated duration of 4 months since the approval date. The study will be conducted at the Fundación Esclerosis Múltiple de Madrid (FEMM), where a minimum of 20 participants are expected to be recruited over a maximum period of 2 months since the approval date. 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 preliminary assessment without the medical device. Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 11 weeks. Sessions will be conducted 1 to 2 times per week, depending on the participant's availability. 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. This is the first study investigating the use of the ABLE Exoskeleton in people with MS, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe and has adequate performance for the intended MS population in a clinical setting. The secondary hypothesis is that the device will have a positive impact on the muscular strength, spasticity, perceived rate of exertion, mobility, satisfaction, and quality of life of the study participants.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2024-02-15
• Last updated: 2024-07-31

Locations

1 site across 1 country: Spain