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Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting

NCT07050875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-27

No results posted yet for this study

Summary

The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.

The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

Conditions

  • Acquired Brain Injury (Including Stroke)

Interventions

DEVICE

ABLE Exoskeleton

Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes.

Sponsors & Collaborators

  • Centro Europeo de Neurociencias (CEN)

    collaborator UNKNOWN

  • Cefine Neurología (CEFINE)

    collaborator UNKNOWN

  • Fundación Step by Step (SBS)

    collaborator UNKNOWN

  • ABLE Human Motion S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-12-17
Completion
2025-12-17

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 NCT07050875 on ClinicalTrials.gov