Spinal Cord InjuriesNCT04876794
Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
A study testing ABLE Exoskeleton in people with Spinal Cord Injuries, run by ABLE Human Motion S.L. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- ABLE Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Nov 2020to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Spinal Cord Injury Center | Heidelberg University Hospital
Heidelberg, 69118
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- ABLE Exoskeleton
- Keywords
- Spinal Cord Injury, Exoskeleton, Robotics, Gait, Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia, Walking, Assistive technology, Usability, Safety, Feasibility, Multicenter
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE ExoskeletonDevice
Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions. Receives: Device: ABLE Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
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.
Measured: Up to 10 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.
Measured: Up to 8 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.
Measured: Up to 8 weeks
Secondary outcomes (8)
BORG Scale
Measurement of the percieved rate of exertion. The BORG scale measures the subjective level of intensity in physical work on a 15-grade scale.
Measured: Up to 7 weeks
6-Minute Walk Test (6 MWT)
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.
Measured: Up to 7 weeks
10-Meter Walking Test (10 MWT)
The 10MWT will be performed using the first 10 meters of the 6-minute walking test.
Measured: Up to 7 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.
Measured: Up to 7 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.
Measured: Up to 7 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.
Measured: Up to 10 weeks
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
Used to measure user satisfaction from participants and therapists. QUEST 2.0 is designed to measure the level of satisfaction and the value people attribute to assistive technologies.
Measured: Up to 10 weeks
Psychosocial Impact of Assistive Devices Scale (PIADS)
The PIADS is a 26-item (7-point Likert-Scale), self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start3 Nov 2020
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABLE Human Motion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Guttmann, Heidelberg University Hospital Spinal Cord Injury Center
- Responsible party
- Sponsor
- Investigators
- Rüdiger Rupp, PD Dr., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876794
- Sponsor's protocol ID
- ABLEexoSCIhospital
- Other IDs
- CIV-20-07-034264
- Status last verified
- Jul 2021
- First submitted
- 30 Apr 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting
- ClinicalTrials.gov ID
- NCT04876794
- Acronym / sponsor ID
- ABLEexoSCIhospital
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Exoskeleton, Robotics, Gait, Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Institut Guttmann, Heidelberg University Hospital Spinal Cord Injury Center
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: ABLE ExoskeletonParticipants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABLE ExoskeletonParticipants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions. | Device | Arm 1 |
Primary outcome
Safety
Time frame: Up to 10 weeks
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.
Time and Level of Assistance (LoA) to don/doff the device
Time frame: Up to 8 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 both the patient and the therapist on performing the activity. This outcome measure will be used to assess the device's usability.
Level of Assistance (LoA) to complete therapy activity tasks
Time frame: Up to 8 weeks
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.
8 secondary outcomes
BORG Scale
Time frame: Up to 7 weeks
6-Minute Walk Test (6 MWT)
Time frame: Up to 7 weeks
10-Meter Walking Test (10 MWT)
Time frame: Up to 7 weeks
Timed up and go test (TUG)
Time frame: Up to 7 weeks
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Up to 7 weeks
Spinal Cord Independence Measure (SCIM III)
Time frame: Up to 10 weeks
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)
Time frame: Up to 10 weeks
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rüdiger Rupp, PD Dr. principal investigator
University Hospital Heidelberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLE Exoskeleton in people with Spinal Cord Injuries, run by ABLE Human Motion S.L. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.