Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- ABLE Human Motion S.L.
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Tme to complete Home-Skills-Test and LoA for each task and ti [Usability/Feasibility]
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 and easier to use.
The primary objective of this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills in home and community environments.
Detailed Description
The primary objective of this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills for home and community environments during a training programme of up to 8 weeks. Results will be used to assess the potential of the device to be used in a home and community setting by persons with SCI, while providing meaningful insights to develop future features to improve its performance in those environments. The secondary objectives are as follows: * Assess the impact of ABLE Exoskeleton training on gait and function. * Assess the effect of the ABLE Exoskeleton on the patients' perceived rate of exertion. * Assess the impact of the ABLE Exoskeleton on the quality of life and general health of the participants. * Assess the level of user satisfaction from participants and therapists of the ABLE Exoskeleton. * Assess the psychosocial impact of the ABLE Exoskeleton for participants. The primary hypothesis of this study is that the ABLE Exoskeleton is feasible to be used by persons with SCI to perform skills for home and community environments. The secondary hypothesis is that the device will have a positive impact on the perceived rate of exertion, mobility and psychosocial health, and quality of life and general health of the study participants with SCI. This is a multicenter pre-post quasi-experimental study. The pre-post period will cover 22 exoskeleton sessions (18 training sessions and 4 assessment sessions) over a period of up to 8 weeks. The study will have two centres specialized in SCI involved, one at Heidelberg University, Germany and another at Institut Guttmann, Spain. In total 10 patients will be recruited. After obtaining a Patient Information Sheet and Informed Consent Form (PIS/ICF), patients will be screened. Patients who match inclusion and exclusion criteria and pass pre-study screening, will be enrolled into the study. First, there will be a familiarisation session (session 0), where participants will learn how to use the device. Participants will then undergo a training programme with the ABLE Exoskeleton three to five times a week for up to 8 weeks for a total of 18 training sessions and 4 assessment sessions. The assessment sessions with the device will be performed at 4 time-points throughout training: Baseline (Session 1), Mid-training (Session 11), Final-training (Session 21) and Home-Skills-Test (Session 22). This therefore means there will be a total of 22 exoskeleton sessions, including training and assessments. During each training session, feasibility measurements will be taken via the evaluation of the performance of exoskeleton skills. Four weeks after the post-training assessment, 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 70 years of age
- •Traumatic and non-traumatic SCI
- •Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or, Motor Complete SCI with NLI T1-L5
- •Time since onset of SCI \> 6 months
- •Ability to give informed consent
Exclusion Criteria
- •WISCI II without exoskeleton of \>13
- •5 or more risk factors present for fragility as stated by Craven et al (Craven et al., 2009a).
- •History of lower limb fragility fractures in the last 2 years
- •Deterioration \> 3 points of the total ISNCSCI motor score within the last 4 weeks
- •Spinal instability
- •Modified Ashworth scale 4 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 the participant to follow the study procedures
- •Known pregnancy or breastfeeding
Outcomes
Primary Outcomes
Tme to complete Home-Skills-Test and LoA for each task and ti [Usability/Feasibility]
Time Frame: Up to 11 weeks
A Home-skills-test will be performed by all participants and will consist of 10 of the skills for home and community environments, set out in a sequence to simulate daily life situations. The test will be attempted twice with a 5 min break in between, the best result will be documented. To assure safety, participants will attempt the test with assistance from the therapist as required. For all skills of the Home-skills-test, the LoA to complete each task and the time to complete the test will be documented.
Time and Level of Assistance (LoA) to don/doff the device [Usability/Feasibility]
Time Frame: Up to 11 weeks
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 the patient and the therapist in performing the activity.
LoA to complete skills for home and community environments [Usability/Feasibility]
Time Frame: Up to 11 weeks
The participant will attempt a set of skills for home and community environments every session to assess the device's usability. The therapist will record the LoA required to complete each task during every session. The best LoA-Score of all 15 tasks within 3 consecutive training sessions will be recorded and analysed (sessions 2-4, sessions 5-7, sessions 8-10, sessions 11-14, sessions 15-17, sessions 18-20).
Number of steps taken with the device [Usability/Feasibility]
Time Frame: Up to 11 weeks
The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.
Distance walked with the device [Usability/Feasibility]
Time Frame: Up to 11 weeks
The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.
Walking time with the device [Usability/Feasibility]
Time Frame: Up to 11 weeks
The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.
Standing time in the device [Usability/Feasibility]
Time Frame: Up to 11 weeks
The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.
Secondary Outcomes
- 6-Minute Walk Test (6 MWT) [Gait and function](Up to 11 weeks)
- BORG Scale [Perceived rate of exertion](Up to 11 weeks)
- 10-Meter Walking Test (10 MWT) [Gait and function](Up to 11 weeks)
- Timed up and go test (TUG) [Gait and function](Up to 11 weeks)
- Walking Index for Spinal Cord Injury (WISCI II) [Gait and function](Up to 11 weeks)
- Spinal Cord Independence Measure (SCIM III) [Gait and function](Up to 11 weeks)
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [User satisfaction](Up to 11 weeks)
- Psychosocial Impact of Assistive Devices Scales (PIADS) [Psychosocial impact on participants](Up to 11 weeks)
- WHO Quality of Life brief form (WHOQOL-BREF) [Participants Quality of Life assessment](Up to 11 weeks)
- Self-report questionnaire on the perceived impact on general health.(Up to 11 weeks)