Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients

NCT07670325 | Recruiting DMC

• 2 other identifiers: F4MR - AKO-R FeasibilityFit4MedRob grant n PNC0000007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

exoskeleton; robotics rehabilitation; stroke

Outcome Measures

Primary Outcomes (3)

• Number of device-related adverse events

  through study completion, an average of 1 year

• Step Length Symmetry Index Change

  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

  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 Outcomes (6)

• Range of motion Change

  Day 4

• Self-selected velocity Change

  Day 5

• Endurance

  Day 5

• Usability score

  Day 5

• Acceptability

  Day 5

Study Arms (1)

Exo-Assisted

EXPERIMENTAL

Patients perform gait training on treadmill and overground with assistance of the investigational device

Device: Exo-Assisted

Interventions

Exo-Assisted DEVICE

Participants perform gait training assiste by the knee exoskeletn investigational device

Exo-Assisted

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna: lead

Study Sites (1)

Don Gnocchi - Centro "S. Maria della Provvidenza"

Roma, RM, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: June 26, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

IT (1)