Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients (AKO-R)

June 24, 2026 updated by: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici

This clinical investigation aims to evaluate the safety, feasibility, and preliminary performance of the AKO-R wearable robotic device for knee assistance during walking. The study involves participants performing treadmill and overground gait training under supervised conditions, with the device providing assistive torque to support movement. Clinical and functional outcomes are assessed using validated measurement tools, while additional data are collected to characterize user performance and interaction with the device. The study is designed as an exploratory investigation to gather evidence supporting the clinical use and further development of the device. Primary outcomes regards safety of the device and preliminary clinical benefit on gait symmetry.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is structured in 5 sessions. The first and last session are the assessment. the 2nd session is the session for calibration of the exoskeleton parameters. The 3rd session is for exo familiarization and the 4th exo is for exo-assisted condition evaluation.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00166
        • Recruiting
        • Don Gnocchi - Centro "S. Maria della Provvidenza"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed stroke with fMRI
  • within 2 years from stroke event
  • FAC>= 3
  • height [1.5 - 2]m
  • weigth <= 100 Kg

Exclusion Criteria:

  • MoCA<18
  • Pregnancy
  • Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs)
  • Recent or current participation in research studies that, in the opinion of the Principal Investigator, may affect the subject's response to the study intervention
  • Severe aphasia
  • MAS=4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exo-Assisted
Patients perform gait training on treadmill and overground with assistance of the investigational device
Device: Exo-Assisted
Participants perform gait training assiste by the knee exoskeletn investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of device-related adverse events
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Step Length Symmetry Index Change
Time Frame: Day 4
The Step Length Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across >20 steps. Score closer to 0 means a better outcome.
Day 4
Stance Time Symmetry Index Change
Time Frame: Day 4
The Stance Time Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across >20 steps. Score closer to 0 means a better outcome.
Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion Change
Time Frame: Day 4
The Range of motion (computed as difference between minimum and maximum joint angle in a step) will be compared across conditions. Descriptive data are averaged across >20 steps
Day 4
Self-selected velocity Change
Time Frame: Day 5
Effect of 3 sessions on self-selected velocity, compared with Session 1. Evaluated with 10 meter walking test
Day 5
Endurance
Time Frame: Day 5
Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test.
Day 5
Usability score
Time Frame: Day 5
Evaluated with System Usability Scale (SUS) questionnaire. The SUS score ranges from a minimum of 0 to a maximum of 100.
Day 5
Acceptability
Time Frame: Day 5
Evaluated with Technology Acceptance Model (TAM) questionnaire. The TAM score goes from a minimum of 0 to a maximum score of 100.
Day 5
Satisfaction Score
Time Frame: Day 5
Evaluated with Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0). The QUEST goes from a minimum of 0 to a maximum of 100.
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborators

Fondazione Don Carlo Gnocchi Onlus
Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F4MR - AKO-R Feasibility
  • Fit4MedRob grant n PNC0000007 (Other Grant/Funding Number: Fit4MedRob Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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