StrokeAKO-RNCT07670325
Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
A study testing Exo-Assisted in people with Stroke, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exo-Assisted
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed stroke with fMRI
- within 2 years from stroke event
- FAC>= 3
- height [1.5 - 2]m
- weigth <= 100 Kg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Don Gnocchi - Centro "S. Maria della Provvidenza"
Roma, RM, 00166
Principal Investigator, +39 0633086500, iaprile@dongnocchi.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Exo-Assisted
- Keywords
- exoskeleton, robotics rehabilitation, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exo-AssistedDevice
Participants perform gait training assiste by the knee exoskeletn investigational device
| Study group | Role | What they receive |
|---|---|---|
| Exo-Assisted | Experimental | Patients perform gait training on treadmill and overground with assistance of the investigational device Receives: Device: Exo-Assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device-related adverse events
Measured: 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.
Measured: 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.
Measured: Day 4
Secondary outcomes (6)
Range of motion Change
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
Measured: Day 4
Self-selected velocity Change
Effect of 3 sessions on self-selected velocity, compared with Session 1. Evaluated with 10 meter walking test
Measured: Day 5
Endurance
Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test.
Measured: Day 5
Usability score
Evaluated with System Usability Scale (SUS) questionnaire. The SUS score ranges from a minimum of 0 to a maximum of 100.
Measured: Day 5
Acceptability
Evaluated with Technology Acceptance Model (TAM) questionnaire. The TAM score goes from a minimum of 0 to a maximum score of 100.
Measured: Day 5
Satisfaction Score
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.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start22 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670325
- Sponsor's protocol ID
- F4MR - AKO-R Feasibility
- Other IDs
- Fit4MedRob grant n PNC0000007
- Acronym
- AKO-R
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
- ClinicalTrials.gov ID
- NCT07670325
- Acronym / sponsor ID
- AKO-R / F4MR - AKO-R Feasibility
- Conditions
- Stroke
- Keywords
- exoskeleton, robotics rehabilitation, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'AnnaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, Fondazione Don Carlo Gnocchi ETS
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exo-Assisted | Experimental | Device: Exo-AssistedPatients perform gait training on treadmill and overground with assistance of the investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed stroke with fMRI
- within 2 years from stroke event
- FAC>= 3
- height [1.5 - 2]m
- weigth <= 100 Kg
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exo-AssistedParticipants perform gait training assiste by the knee exoskeletn investigational device | Device | Exo-Assisted |
Primary outcome
Number of device-related adverse events
Time frame: 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.
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.
6 secondary outcomes
Range of motion Change
Time frame: Day 4
Self-selected velocity Change
Time frame: Day 5
Endurance
Time frame: Day 5
Usability score
Time frame: Day 5
Acceptability
Time frame: Day 5
Satisfaction Score
Time frame: Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exo-Assisted in people with Stroke, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of device-related adverse events (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.