paraplegia Spinal cord injury spinal cord injury
Conditions
Interventions
ABLE Daily exoskeleton use in the home and community settings.
Sponsors
ABLE Human Motion
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: At least 18 years old Chronic SCI (>6 months) Injury at levels T1 to L5 (AIS A to D) Walking Index Spinal Cord Injury (WISCII) 0 till 9 Between 150-200 cm Weight less than 100 kilograms Capable of giving informed consent on their own Able to train (at least) 3 days/week Able to have at least 1 companion/buddy who can attend a minimum of two of the training sessions, besides the Final assessment, and who will learn how to assist them at home and in the community. (ideally two companions)
Exclusion criteria
Exclusion criteria: High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip T-score < -3.5 and for the distal femur and proximal tibia T-score < -3 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 Disorders of the arms and hands that make walking with crutches impossible Modified Ashworth Scale (MAS) >3 in lower limbs Cardiovascular health issues which prevent the participant from training Inability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation Skin problems in areas that would be in contact with the device Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device Insufficient joint range of motion (ROM) for the device Known pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess the impact of the ABLE Daily use on the perceived general health of the participants, the gait performance with the ABLE Daily using data collected from the exoskeleton, and the level of user satisfaction from participants, companions, and therapists. | — |
Countries
Netherlands
Contacts
Public ContactD Oosterling
Sint Maartenskliniek
Outcome results
None listed