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NCT Number: NCT07670325

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Don Gnocchi - Centro "S. Maria della Provvidenza"

Roma, RM, 00166, Italy

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

+39 0633086500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exo-Assisted

Device

Participants perform gait training assiste by the knee exoskeletn investigational device

Primary outcomes

  1. Number of device-related adverse events

    Time frame: through study completion, an average of 1 year

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Endurance

    Time frame: Day 5

    Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test.

  4. 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.

  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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • Istituti Clinici Scientifici Maugeri SpA

Registry information

Official study title

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

Acronym: AKO-R

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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