Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-ES-22-09-040647 | Registry Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital ASEPEYO Sant Cugat | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
The primary objective of this study is to determine the impact of the performed design changes on safety, feasibility, and usability of the ABLE Exoskeleton for patients with SCI in a hospital setting during a 5-6 week training programme.
The secondary objectives are as follows:
Patients who match inclusion and exclusion criteria and pass pre-study screening will be enrolled in the study. Following the screening, baseline assessments will be conducted without the device. Participants will undergo a training programme with the ABLE Exoskeleton two times a week for five weeks for a total of 10 sessions. Standardized clinical assessments with the device will be performed during the last training sessions. During the training period, several safety and usability measurements will be taken. Two weeks after the final training session a follow-up assessment will be conducted with participants. At the end of the study, the participating therapists will be asked to fill out a satisfaction questionnaire.
The primary hypothesis of this study is that the ABLE Exoskeleton remains safe, feasible, and usable for the intended patient population with SCI in a hospital setting after the implementation of the design changes improving its performance. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility, and level of satisfaction of the study participants with SCI.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Treatment | Experimental | Participants with SCI will undergo a training programme with the ABLE Exoskeleton device two times a week for five weeks for a total of 10 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLE Exoskeleton | Device | The ABLE Exoskeleton is a lower-limb overground robotic exoskeleton intended for SCI patients for rehabilitation in a clinical setting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of Adverse Events [Safety and Tolerability] | To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported. | Up to 8 weeks |
| Time and Level of Assistance (LoA) to don/doff the device | Level of Assistance (LoA) and time taken to don/doff the device will be measured in every session. LoA will be measured using a 6 item scale, from Total assistance to Independence. Different assistance levels are defined taking into account the degree of participation of both the patient and the therapist on performing the activity. This outcome measure will be used to assess the device's usability. | Up to 6 weeks |
| Level of Assistance (LoA) to complete therapy activity tasks | Four therapy activity tasks will be attempted every session by the participant. The therapist will record the LoA required to complete each task during the session. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit. Different assistance levels are defined taking into account the degree of participation of both the patient and the therapist in performing the activity. This outcome measure will be used to assess the device's usability. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BORG Scale | Measurement of the perceived rate of exertion. The BORG scale measures the subjective level of intensity in physical work on a 15-grade scale. It will be measured after performing the 6 Minute Walk Test (6 MWT) with the device. | Up to 6 weeks |
| 6-Minute Walk Test (6 MWT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Asepeyo Sant Cugat | Sant Cugat del Vallès | Barcelona | 08174 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40331262 | Derived | Porras-Martinez E, Kreamer-Tonin K, Lobo-Prat J, Lopez-Matas H, Carnicero-Carmona A, Tolra-Campanya M, Perez-Canabate F, Estay-Girardi J, Samitier-Pastor B. Enhancing exoskeleton technology through co-creation with clinicians and patients: a pilot study and comparative analysis of the ABLE exoskeleton. Disabil Rehabil. 2025 Nov;47(23):6217-6231. doi: 10.1080/09638288.2025.2496351. Epub 2025 May 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
6 Minute Walk Test (6 MWT) measures the distance a person can walk in 6 minutes. There are different possibilities for performing this test. For this study, we will use a track of 50 meters, where patients walk back and forth. |
| Up to 6 weeks |
| 10-Meter Walking Test (10 MWT) | The 10-Meter Walking Test (10 MWT) measures the time required to walk 10 meters. The test will be performed with a dynamic start with an acceleration distance of 2 meters, a timed 10 meters distance and a deacceleration distance of 2 meters. | Up to 6 weeks |
| Timed up and go test (TUG) | Timed Up and Go Test (TUG) measures the time it takes a person to get up from a chair, walk 3 meters, turn around and sit down again. It is a widely used test to assess balance and the risk of falls in different patient groups. | Up to 6 weeks |
| Walking Index for Spinal Cord Injury (WISCI II) | WISCI II assesses the extent and nature of assistance for walking 10 meters in persons with SCI. Assistance is specified as different combinations of braces, walking aids and physical assistance. The WISCI II consists of 20 levels from unable to walk to the ability to walk 10 meters without any assistance. | Up to 6 weeks |
| Spinal Cord Independence Measure (SCIM III) | SCIM III scale focuses on the ability to perform activities of daily living in persons with SCI. The SCIM III consists of three subscales: Self-Care, Respiratory and Sphincter Management, Mobility (room and toilet) and Mobility (indoors and outdoors, on even surface). A total score of 0 (totally dependent) to 100 (totally independent) points can be achieved. | Up to 6 weeks |
| Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) | Used to measure user satisfaction from participants and therapists. The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) is designed to measure the level of satisfaction and the value people attribute to assistive technologies. It does so using 12 variables which are scored on a 5 point scale in terms of perceived importance and satisfaction. While items 1-8 rate the satisfaction with the device, items 9-12 are for assessing the satisfaction with the service. If the users are not very satisfied with a feature, they are asked to provide specific feedback. The final score is the mean sum scores of all valid responses with a range of 1 (not satisfied at all) to 5 (very satisfied). | Up to 6 weeks |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided