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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorABLE Human Motion S.L.

About this trial

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).

Eligibility criteria

Qualifiers

At least 18 years old

Chronic SCI (>6 months)

Injury at levels T1 to L5 (AIS A to D)

Walking Index for Spinal Cord Injury (WISCI) score 0 until 9

Disqualifiers

High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score

Fragility fractures of the lower limbs in the last 2 years

Deterioration >3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks

Spinal instability, like spondylolisthesis

Trial design

Treatments tested in this trial

  • ABLE Daily

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

ABLE Human Motion S.L.

Lead sponsor

Sint Maartenskliniek

Collaborator

Universitat Politècnica de Catalunya

Collaborator