Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT04876794
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Sponsor:
ABLE Human Motion S.L.
Organization:
Study Overview
Official Title:
Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 (9 kg) and easier to use.
The primary objective of the study is to investigate the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a four to six weeks gait training in clinical settings. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.
The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter (9 kg) and easier to use.
The primary objective of the study is to investigate the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a four to six weeks gait training in clinical settings. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.
Detailed Description:
The primary objective of this study is to determine the safety, feasibility, and usability of using the ABLE Exoskeleton for patients with SCI in a hospital setting during a 4-6 week training programme.
The secondary objectives are as follows:
* Assess the impact of ABLE Exoskeleton training on gait and function.
* Assess the effect on the perceived rate of exertion for patients using the ABLE Exoskeleton.
* Assess the level of user satisfaction from participants and therapists of the ABLE Exoskeleton.
* Assess the psychosocial impact of the ABLE Exoskeleton for participants
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 three times a week for four weeks for a total of 12 sessions. Standardized clinical assessments with the device will be performed during the first and the last training sessions. During the training period, several safety and usability measurements will be taken. After the last training session, baseline assessments without the exoskeleton will be repeated during a post-study assessment. Four 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.
This is the first study investigating the use of the ABLE Exoskeleton, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe, feasible, and usable for the intended patient population with SCI in a hospital setting. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility, and psychosocial health of the study participants with SCI.
The secondary objectives are as follows:
* Assess the impact of ABLE Exoskeleton training on gait and function.
* Assess the effect on the perceived rate of exertion for patients using the ABLE Exoskeleton.
* Assess the level of user satisfaction from participants and therapists of the ABLE Exoskeleton.
* Assess the psychosocial impact of the ABLE Exoskeleton for participants
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 three times a week for four weeks for a total of 12 sessions. Standardized clinical assessments with the device will be performed during the first and the last training sessions. During the training period, several safety and usability measurements will be taken. After the last training session, baseline assessments without the exoskeleton will be repeated during a post-study assessment. Four 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.
This is the first study investigating the use of the ABLE Exoskeleton, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe, feasible, and usable for the intended patient population with SCI in a hospital setting. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility, and psychosocial health of the study participants with SCI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-20-07-034264 | REGISTRY | EUDAMED | View |