NCT07062575

Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.

Clinical Investigation on the Safety and Performance of the ABLE Daily to Assist People With Spinal Cord Injury in Performing Ambulatory Functions in Home and Community Settings

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ABLE Human Motion S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury. The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).

Detailed description

The ABLE Daily Exoskeleton is a wearable powered lower-limb exoskeleton that actively assists individuals with spinal cord injury to stand up, walk, ascend and descend a ramp of 5 degrees and sit down. The device consists of a rigid brace that attaches to the torso, legs and feet of the user via straps and supports. It is a bilateral robotic exoskeleton with four battery-powered motors that drive the knee and hip joints assisting in flexion-extension. The other degrees of freedom of the hip and knee joints are restricted. The ankle joint of the exoskeleton is passively articulated with a spring within a limited range of motion. The experimental period will cover the training period happening at the investigational site where the participants and their companions will be trained 3 times a week. They will then have to perform a community skills test, if passed they will be allowed to take the exoskeleton home and use it in their daily life for 12 weeks. Pre and post assessments will be made.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	ABLE Daily	The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks

Timeline

• Start date: 2025-06-19
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-07-14
• Last updated: 2026-01-27

Locations

1 site across 1 country: Netherlands