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Spinal Cord InjuriesNCT04855916

KAFO Orthoses Versus the ABLE Exoskeleton

A study testing ABLE Exoskeleton and KAFO Orthosis in people with Spinal Cord Injuries, run by ABLE Human Motion S.L. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting. 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 and KAFO Orthosis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
17 Feb 2021to 17 Sep 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

  • From 18 to 70 years old
  • Chronic or subacute spinal cord injury.
  • Currently in treatment as in-patient or ambulatory in the investigational site.
  • From AIS A to AIS D with enough arm strength to withstand the bodyweight in a walking frame.
  • Previous experience walking with KAFO orthoses (must tolerate standing).
  • Ability to give informed consent

Who cannot join

  • WISCI II >16 without the exoskeleton.
  • 5 or more fragility fracture risk factors according to Craven et al.
  • History of fragility fractures of lower limbs in the past 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 minutes standing without clinical symptoms of orthostatic hypotension.
  • Unable to walk 5 meters with KAFO orthoses and the support of a walking frame with wheels.
  • 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

1 site in 1 country.

Spain1 site

  • Hospital Asepeyo Sant Cugat

    Sant Cugat del Vallès, Barcelona, 08174

Other trials in Spain

About this study

Official title: ABLE Exoskeleton vs KAFO Orthosis: Comparative Study of Gait Kinematics and Energy Efficiency in Patients With Spinal Cord Injury

This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting. The ABLE Exoskeleton is a robotic exoskeleton that actively assists individuals with mobility problems to stand up, walk and sit down.

The main objective of the study is to compare the energy efficiency during gait with both devices. Secondary objectives are: compare gait kinematics, usability, user's satisfaction, physical activity and psychosocial impact. The study will also serve to evaluate the usability and safety of the ABLE Exoskeleton in clinical practice.

Subjects will complete 10 gait training sessions during a 5-week period with 1 of the 2 devices randomly selected, followed by a post-training assessment consisting of 1 session. Once the test is completed, subjects will have a 2-week rest period after which they will repeat the process with the other device for 5 weeks (followed by 1 post-training assessment session). The study will be conducted at Hospital Asepeyo Barcelona in Spain, where a total of 10 patients will be recruited.

Read the detailed description

The primary objective of this study is determining the energy efficiency through gases exchange and kinematic gait analysis to compare the standard of assistance (KAFO type orthoses) and the ABLE Exoskeleton, a robotic gait assistance device, in patients with spinal cord injury (SCI) in a hospital setting.

The secondary objectives are to compare the performance of KAFO-type orthoses with that of the ABLE Exoskeleton device by:

  • Kinematic analysis of gait and spatiotemporal gait parameters.
  • Evaluation of the time and effort required to learn to use the device (usability).
  • Evaluation of the impact that physical activity has on participants after gait training.
  • Evaluation of the level of satisfaction of the participants.

In addition to these objectives, the safety of the ABLE Exoskeleton as an assistive device for gait rehabilitation in SCI patients will be evaluated throughout the study.

Participants will perform 2 training sessions per week of approximately 90 minutes duration for 5 weeks with each of the devices, completing a total of 10 sessions with KAFO type orthoses and 10 sessions with the ABLE Exoskeleton. Before starting the training period, the physical capacity of the participants will be measured. During the training period sessions, different measurements of the level of assistance, spatiotemporal gait variables and usability will be taken. Standardized clinical assessments will also be performed during sessions 5 and 10 (assessment sessions). At the end of the training period, a post-training assessment will be performed, consisting of 1 session where the physical capacity of the participants will be measured. After finishing the training period with one of the devices, participants will have a rest period of 2 weeks, after which they will change devices and repeat the whole process.

The main hypothesis of the study is that gait efficiency in patients with SCI is improved (lower energy consumption) when using the ABLE Exoskeleton device in comparison with KAFO-type orthoses. The increase in gait efficiency encourages patients to stand and walk for longer periods instead of using the wheelchair, which boosts their rehabilitation and improves their health.

Secondary hypotheses are:

  • The ABLE Exoskeleton device will improve the kinematics and spatiotemporal parameters of gait (more closely resemble the gait pattern of a healthy individual), relative to KAFO-type orthoses.
  • The ABLE Exoskeleton device will have a more positive impact on the mobility and psychosocial health of participants with SCI in the study, with respect to KAFO-type orthoses.
  • The ABLE Exoskeleton device is a safe device to use in a hospital setting as an assistive device during gait rehabilitation in SCI patients.
Being tested
ABLE Exoskeleton, KAFO Orthosis
Keywords
Spinal Cord Injury, Exoskeleton, KAFO, Gait, Rehabilitation, Lower-limb, Gait Kinematics, Robotics, Energy Efficiency, Oxygen Consumption, Gas exchange, Neurorehabilitation, Paraplegia, Walking, Passive orthoses, Assistive technology, Usability, Randomized crossover
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 will use the ABLE Exoskeleton to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.

  • KAFO OrthosisDevice

    Participants will use a pair of KAFO-type passive orthosis to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.

Study groups in NCT04855916
Study groupRoleWhat they receive
ABLE Exoskeleton - KAFOExperimentalParticipants belonging to this arm start the study by performing the training program using the ABLE Exoskeleton. After the resting period, they repeat the training program using KAFO orthoses.
Receives: Device: ABLE Exoskeleton; Device: KAFO Orthosis
KAFO - ABLE ExoskeletonExperimentalParticipants belonging to this arm start the study by performing the training program using the KAFO orthoses. After the resting period, they repeat the training program using the ABLE Exoskeleton.
Receives: Device: ABLE Exoskeleton; Device: KAFO Orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of gas exchange during 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 at least 10 meters, where patients walk back and forth.

    Measured: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.

  2. Measurement of gas exchange during the 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: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.

  3. Measurement of gas exchange during Graded exercise testing (GXT)

    Maximal Graded Exercise Test (GXT) is a screening tool to track an individual's fitness level. The test evaluates the participant's exercise capacity by measuring the cardiovascular response to physical activity. Through this test, the values of maximal oxygen consumption will be obtained and used to obtain metrics to assess energy efficiency during the gait.

    Measured: Change from preliminary assessment through study completion, an average of 16 weeks.

  4. Measurement of gas exchange during 10 Meter Walk Test (10MWT)

    The 10 Meter Walk Test (10 MWT) measures the time a person needs to walk 10 meters. The test is performed with a dynamic (flying) start with two-meter acceleration, a timed ten-meter distance and two-meter deceleration.

    Measured: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.

Secondary outcomes (6)

  1. Measurement of the Level of Assistance to perform therapy activities.

    To measure the time required to learn to use the device under investigation, different activities (don/doff, balance, walking, advanced abilities) will be performed during the training period. The difficulty of each activity increases as they are completed.

    Measured: Up to 5 weeks

  2. Perceived level of exertion

    For measuring impact on the perceived level of exertion, the BORG will be tested after the 6 MWT/TUG/GXT with and without the device. The BORG scale measures the subjective level of intensity in physical work on a 15-grade scale. It ranges from 6 (No exertion at all) to 20 (Maximal exertion).

    Measured: Up to 6 weeks

  3. Fatigue Visual Analog Scale (VAS)

    The scale consists of a straight line where one end means the absence of fatigue and the other end means maximal fatigue. The patient selects a point in the line which coincides with their level of fatigue.

    Measured: Up to 6 weeks

  4. Spinal Cord Independence Measure (SCIM) III

    Spinal Cord Independence Measure (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 days before first session and up to 10 days after first session

  5. Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)

    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).

    Measured: Up to 6 weeks

  6. Psychosocial Impact of Assistive Devices Scales (PIADS)

    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. It is divided into three subscales: Competence, adaptability and self-esteem. For each of the subscales, typically means are calculated that range from -3 (maximum negative impact) to +3 (maximum positive impact). To have only positive sum scores, the range of the individual scores are shifted to 1 to 7, meaning that the sum scores range from 1 *26 (26, maximum negative impact) to 7 *26 (182, maximum positive impact). The PIADS is a responsive measure and sensitive to important variables such as the user's clinical condition, device stigma, and functional features of the device. It has been shown to accurately reflect the self-described experiences of people who use assistive devices.

    Measured: Up to 6 weeks and followup (4 weeks after study completion).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start17 Feb 2021
  3. Primary completion13 Sep 2021
  4. Study completion17 Sep 2021

Resources

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
Randomised
Intervention model
Crossover
Model description
Participants will complete 10 gait training sessions during a 5-week period with one of the two devices (ABLE Exoskeleton or KAFO orthoses) followed by a post-training assessment. After the training program with the first device, participants will have 2 weeks resting time, after which they will repeat the process with the other device. The initial device assignment (ABLE Exoskeleton or KAFO) is performed randomly.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855916
Sponsor's protocol ID
ABLEexovsKAFO
Status last verified
Oct 2021
First submitted
25 Mar 2021
Last updated
4 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ABLE Exoskeleton and KAFO Orthosis in people with Spinal Cord Injuries, run by ABLE Human Motion S.L. at 1 site in Spain.

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 6 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Measurement of gas exchange during 6 Minute Walk Test (6 MWT) (time frame: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04855916.

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 4 Oct 2021.

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KAFO Orthoses Versus the ABLE Exoskeleton | AzTrials