Clinical Investigation on the Impact on Safety, Feasibility and Usability of the Design Changes P… (NCT05590065) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation on the Impact on Safety, Feasibility and Usability of the Design Changes Performed on ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Spain5 participantsStarted 2022-10-19
Plain-language summary
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians. Exoskeletal technology has the potential to help people with impaired leg function to regain ambulation and thus improve their independence. This technology is not completely new, but due to their high access price (\~120k€/unit), high size and weight (\~25 kg), and need for trained physiotherapist supervision, commercially available exoskeletons are only found in large hospitals and only in very few cases get into patients' homes.
The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter and easier to use.
The primary objective of the study is to investigate the impact of recent design changes performed on the device on the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a five to six weeks gait training programme in a clinical setting. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 70 years of age.
* Traumatic and non-traumatic SCI.
* SCI with Neurological Level of Injury (NLI) C5-L5 (from AIS A to AIS D).
* Currently treated as inpatient or outpatient in the investigation center.
* Ability to give informed consent.
Exclusion Criteria:
* WISCI II without exoskeleton of \>13
* 5 or more risk factors for fragility as stated by Craven et al (Craven et al., 2009).
* 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) of 4 in lower limbs.
* Unable to tolerate 30 min standing without clinical symptoms of orthostatic hypotension
* Psychological or cognitive issues that do not allow a participant to follow the study procedures.
* Known pregnancy or breastfeeding.
* Any neurological condition other than SCI.
* Medically unstable: Unstable CVS, hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved DVT, uncontrolled AD.
* Severe comorbidities: any condition that a physician considers to not be appropriate to complete participation in the study.
* Ongoing skin issues: Grade I or higher on EPUAP on areas that will be in contact with exoskeleton (European Pressure Ulcer Advisory Panel, 2019).
* Range of motion (ROM) restrictions in lower extremities, that are incompatible with th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and type of Adverse Events [Safety and Tolerability]
Timeframe: Up to 8 weeks
2
Time and Level of Assistance (LoA) to don/doff the device
Timeframe: Up to 6 weeks
3
Level of Assistance (LoA) to complete therapy activity tasks