G82
Conditions
Interventions
Group 1: Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.
Sponsors
ABLE Human Motion S.L.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Traumatic and non-traumatic SCI ? Currently receiving treatment as an inpatient or outpatient at one of the investigational sites ? AIS A to AIS D with sufficient arm strength to support body weight on a walking frame ? Ability to give informed consent
Exclusion criteria
Exclusion criteria: ? WISCI II without exoskeleton of >16 ? 5 or more risk factors for fragility as stated by Craven et al (29) ? History of lower limb fragility fractures in the last 2 years ? Deterioration > 3 points of the total International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score within the last 4 weeks ? Spinal instability ? Modified Ashworth scale (MAS) > 3 in lower limbs ? Unable to tolerate 30 min standing without clinical symptoms of orthostatic hypotension ? Unable to perform a sit-to-stand transfer or stand in the device with assistance ? Psychological or cognitive issues that do not allow a participant to follow the study procedures ? Any neurological condition other than SCI ? Medically unstable ? Severe comorbidities including any condition that a physician considers to not be appropriate to complete participation in the study ? Ongoing skin issues ? Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device ? Insufficient Range of Motion (ROM) for ABLE Exoskeleton device ? Known pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For safety the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported. Feasibility and usability of the device will be assessed by: Level of Assistance (LoA) and time taken to don/doff the device; LoA to complete therapy activity tasks; Number of steps, walking time and standing time. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The perceived rate of exertion: BORG scale ? Gait and function: 10-Meter Walking Test (10MWT), 6-Minute Walk Test (6MWT), Timed up and go test (TUG), Walking Index for Spinal Cord Injury (WISCI II), Spinal Cord Independence Measure (SCIM III) ? User satisfaction from participants and therapists: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) ? Psychosocial impact on participants: Psychosocial Impact of Assistive Devices Scales (PIADS). The trial includes the following clinical check-ups and visits: ? Screening ? Baseline ? Regular visits at every training session ? Post-training ? Follow-up Follow-up for participants will take place 4 weeks after the last training session. This will include: ? Review of any adverse events reported between therapy end and follow-up ? SCIM III ? QUEST 2.0 ? PIADS Due to the COVID-situation, the follow-up will be held as telephone interview. At the end of the trial the participating therapists will also complete the QUEST 2.0 to gain insight into their views of using the device in the hospital environment. | — |
Countries
Germany, Spain
Contacts
Public ContactRüdiger Rupp
Klinik für Paraplegiologie - Expermimentelle Neurorehabilitation
Outcome results
None listed