KAFO Orthoses Versus the ABLE Exoskeleton

NCT04855916 | Completed

• 1 other identifier: ABLEexovsKAFO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries

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

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

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

  Up to 5 weeks

• Perceived level of exertion

  Up to 6 weeks

• Fatigue Visual Analog Scale (VAS)

  Up to 6 weeks

• Spinal Cord Independence Measure (SCIM) III

  Up to 10 days before first session and up to 10 days after first session

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

  Up to 6 weeks

Other Outcomes (1)

• Gait Analysis

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

Study Arms (2)

ABLE Exoskeleton - KAFO

EXPERIMENTAL

Participants 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.

Device: ABLE Exoskeleton; Device: KAFO Orthosis

KAFO - ABLE Exoskeleton

EXPERIMENTAL

Participants 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.

Device: ABLE Exoskeleton; Device: KAFO Orthosis

Interventions

ABLE Exoskeleton DEVICE

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.

ABLE Exoskeleton - KAFO; KAFO - ABLE Exoskeleton

KAFO Orthosis DEVICE

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.

ABLE Exoskeleton - KAFO; KAFO - ABLE Exoskeleton

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• WISCI II \>16 without the exoskeleton.
• 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
• 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

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Hospital Asepeyo Barcelona: collaborator
• Biomechanical Engineering Lab (BIOMEC) - Universitat Politècnica de Catalunya (UPC): collaborator
• Institut Nacional d'Educació Física de Catalunya (INEFC): collaborator

Study Sites (1)

Hospital Asepeyo Sant Cugat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lluís Guirao Cano, MD PhD

  Hospital ASEPEYO Sant Cugat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 22, 2021
• Study Start: February 17, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 17, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)