Home-based exoskeleton training to help people with spinal cord injury walk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with chronic spinal cord injury will undergo a 3-week on-site training period (9 sessions) followed by 12 weeks of home use with the ABLE Daily exoskeleton. The device is a bilateral wearable exoskeleton that assists hip and knee movement to enable standing, walking, ramp navigation, and sitting. Pre- and post-assessments will measure safety and performance, and training will involve a companion or buddy learning to assist during home use. Eligibility requires adults 18–<em>any</em> with specific SCI levels and functional criteria, plus a willingness and ability to train regularly with a support person.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Height between 150-200 cm
* Weight less than 100 kg
* 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)
* Proficiency in walking with the ABLE Exoskeleton
* At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.

Exclusion Criteria:

* 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
* 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
* Instability 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

Where it's running

• Sint Maartenskliniek
  Hengstdal, Ubbergen, Netherlands Recruiting

Study contacts

• Principal investigator: Noel Keijsers — Sint Maartenskliniek
• Study coordinator: Noel Keijsers
• Email: n.keijsers@maartenskliniek.nl
• Phone: + 31 6 44244217

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.