Clinical trial NCT04876794: Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Official title: Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Exoskeleton
Robotics
Gait
Rehabilitation
Lower-limb
Neurorehabilitation
Paraplegia
Walking
Assistive technology
Usability
Safety
Feasibility
Multicenter
Lead sponsor: ABLE Human Motion S.L.
Sponsor class: INDUSTRY
Collaborators: name: Institut Guttmann
name: Heidelberg University Hospital Spinal Cord Injury Center
First posted: 2021-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years of age
* 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:

* 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

Primary outcomes:
measure: Safety
timeFrame: Up to 10 weeks
measure: Time and Level of Assistance (LoA) to don/doff the device
timeFrame: Up to 8 weeks
measure: Level of Assistance (LoA) to complete therapy activity tasks
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: BORG Scale
timeFrame: Up to 7 weeks
measure: 6-Minute Walk Test (6 MWT)
timeFrame: Up to 7 weeks
measure: 10-Meter Walking Test (10 MWT)
timeFrame: Up to 7 weeks
measure: Timed up and go test (TUG)
timeFrame: Up to 7 weeks
measure: Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Up to 7 weeks
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: Up to 10 weeks
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
timeFrame: Up to 10 weeks
measure: Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Spinal Cord Injury Center | Heidelberg University Hospital
city: Badalona
country: Spain
facility: Institut Guttmann
state: Barcelona
Study officials:
affiliation: University Hospital Heidelberg
name: Rüdiger Rupp, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: