Exoskeleton Training for Spinal Cord Injury Recovery
Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
Recruiting
N/AInterventional Study
Spinal Cord Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
10 (estimated)
Sponsor
ABLE Human Motion S.L. · Industry
Who this trial is looking for
This trial is looking for adults with spinal cord injuries who want to improve their ability to walk. Participants will use an exoskeleton for training sessions at a clinic and then at home for a total period of 15 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have a spinal cord injury for more than 6 months
I have a walking ability score between 0 and 9
I can commit to training at least 3 days a week
I have a companion who can attend training sessions
I weigh less than 100 kg
I am between 150-200 cm tall
I can give informed consent on my own
You may not be able to join if
I have a high risk of fractures due to osteoporosis
I have had fragility fractures in my legs in the last 2 years
I have had a significant deterioration in my condition recently
I have spinal instability issues
I cannot use crutches due to arm or hand problems
I have serious heart health issues that prevent me from training
I have skin problems where the device would touch my body
I am currently pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 a…
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).
Trial Locations
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Eligibility Criteria
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 …
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
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