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Clinical Investigation on the Impact on Safety, Feasibility and Usability of the Design Changes Performed on ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting

NCT05590065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-04-07

No results posted yet for this study

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 and easier to use.

The primary objective of the study is to investigate the impact of recent design changes performed on the device on the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a five to six weeks gait training programme in a clinical setting. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

ABLE Exoskeleton

The ABLE Exoskeleton is a lower-limb overground robotic exoskeleton intended for SCI patients for rehabilitation in a clinical setting.

Sponsors & Collaborators

  • Hospital ASEPEYO Sant Cugat

    collaborator UNKNOWN

  • ABLE Human Motion S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2023-01-16
Completion
2023-01-16

Countries

  • Spain

Study Locations

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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 NCT05590065 on ClinicalTrials.gov