MedTrace Logo

KAFO Orthoses Versus the ABLE Exoskeleton

NCT04855916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-04

No results posted yet for this study

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

Interventions

DEVICE

ABLE Exoskeleton

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.

DEVICE

KAFO Orthosis

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.

Sponsors & Collaborators

  • Hospital Asepeyo Barcelona

    collaborator UNKNOWN

  • Biomechanical Engineering Lab (BIOMEC) - Universitat Politècnica de Catalunya (UPC)

    collaborator UNKNOWN

  • Institut Nacional d'Educació Física de Catalunya (INEFC)

    collaborator UNKNOWN

  • ABLE Human Motion S.L.

    lead INDUSTRY

Principal Investigators

  • Lluís Guirao Cano, MD PhD · Hospital ASEPEYO Sant Cugat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2021-09-13
Completion
2021-09-17

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855916 on ClinicalTrials.gov