StrokeNCT06150430

An Active Pelvis Orthosis (APO) for Post-stroke Gait Rehabilitation: a Pilot Study

A study testing APO in people with Stroke, run by IUVO S.r.l. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to evaluate the safety, reliability and short-term effectiveness of APO-based training to increase the self-selected walking velocity (SSV) of stroke patients. The robotic device is the Active Pelvic Orthosis RT v3.1 (IUVO APO) developed bu IUVO S.r.l. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: APO
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: 30 Mar 2023to 31 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

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

cerebral stroke;
at least 3 months from cerebral event;
hemiparesis;
age > 18 years;
SSV greater than 0.3 (m/s);
SSV less than 0.8 (m/s);
ability to ambulate with no more than minimal contact assistance;
maximum hip width range, i.e., distance between Great Trochanters = 430 mm.

Who cannot join

Modified Ashworth Scale >3 at the hip and/or ankle joints;
inability to follow verbal 3 step commands;
severe aphasia causing inability to communicate with the investigators;
serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures);
leg deep vein thrombosis less than 6 weeks ago;
other pre-existing neurological disorders (Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Dementia);

Show all 19Show fewer

Severe osteoporosis;
severe hip / knee osteoarthritis with limitation of movement or significant pain;
use of a colostomy bag;
skin wounds, infection or problems at device contact locations;
major orthopedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine);
cardiac surgery within the last 3 months;
patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention;
pregnancy;
breastfeeding woman;
implanted cardiac devices (pacemakers, ICDs);
use of assistive device that, in the PI's opinion, could interfere with APO;
it is recommended that participants treated with anti-spasticity agents (oral, injectable or intrathecal) keep the dosage for these medications constant throughout the study;
where medically appropriate, all other concomitant medications being taken by a participant at entry into the study should continue at the same dose until end of study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta
Lecco, 23845

Other trials in Italy

About this study

Read the detailed description

The primary objective of this study is to evaluate the safety, reliability and short-term effectiveness of APO-based training to increase the self-selected walking velocity (SSV) of stroke patients. The endpoint to evaluate the APO-based training effectiveness will be the difference in self-selected walking velocity (m/s) comparing post-training session (T4) to baseline sessions (T1\&T2).

Other objective of the study, both secondary and exploratory, have been defined to further investigate the effects of the IUVO APO on post-stroke subjects.

The Investigational Device, Active Pelvis Orthosis RT v3.1 (APO), is a bilateral powered robotic hip orthosis (or exoskeleton) designed to gently assist hip flexion-extension movements by providing smooth assistive torque at the hip level, automatically adapting to natural gait variations.

The study will be an interventional single-arm clinical trial with no control group and will involve up to 20 subjects, that fulfil the inclusion/exclusion criteria. This should be sufficient to provide the input needed to reach the primary and secondary objectives of the trial.

In the protocol, after the screening visit, subjects will take part in 14 experimental sessions: two baseline sessions (T1-T2), three familiarization sessions (F1-F3), six training sessions (E1-E6), two assessment sessions (one pre-training T3 and one post training T4) and one 2-month follow-up session (T5). Depending on the session, the subject will be asked to walk with or without the APO, or both. During the assessment sessions, the subject will be evaluated through different standard tests (such as 10MWTs and 2mWTs) and instrumented gait analysis, with and without APO. In the training sessions, the subject will perform some overground walking practice with APO.

Conditions: Stroke
Being tested: APO
Keywords: Hip exoskeleton, Cerebrovascular Disorders, Nervous System Diseases
Medical subject headings: Stroke, Cerebrovascular Disorders, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

APODevice
Subjects will take part in 14 experimental sessions: two baseline sessions (T1-T2), three familiarization sessions (F1-F3), six training sessions (E1-E6), two assessment sessions (one pre-training T3 and one post training T4) and one 2-month follow-up session (T5). Depending on the session, the subject will walk with and/or without the APO. During the assessment sessions (T3-T4), the subject will be evaluated through different standard tests (such as 10MWTs and 2mWTs) and instrumented gait analysis, with and without the APO.
The goal of each training session (E1-E6) will be to achieve a minimum of 30 minutes of overground walking assisted by the APO, leaving up to 15 minutes to rest if needed. Training sessions will occur 2-3 times a week for 2-3 weeks to complete the training protocol.

Study groups in NCT06150430
Study group	Role	What they receive
Training with APO	Experimental	All participants are assigned to the training group with the APO Receives: Device: APO

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)
Safety of the device will be assessed by the number of ADEs and SADEs throughout the duration of the study
Measured: Duration of the study participation (estimated 4 weeks, excluding follow-up)
Incidence of Adverse Device Events (ADEs), Serious Adverse Device Events (SADEs) and Device Deficiencies (DDs)
Reliability of the device will be assessed by the number of ADEs, SADEs and DDs throughout the duration of the study
Measured: Duration of the study participation (estimated 4 weeks, excluding follow-up)
10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)
Change in SSV measured without the device
Measured: Baseline, Post-Training (estimated 3-4 weeks)

Secondary outcomes (5)

10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Change in FV measured without the device
Measured: Baseline, Post-Training (estimated 3-4 weeks)
10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)
Change in SSV measured without the device
Measured: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Change in FV measured without the device
Measured: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
2-minute Walk Test (2mWT)
Change in walking endurance measured without the device
Measured: Baseline, Post-Training (estimated 3-4 weeks)
2-minute Walk Test (2mWT)
Change in walking endurance measured without the device
Measured: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202331 Oct 2024

First posted29 Nov 2023
Study start30 Mar 2023
Primary completion31 Oct 2024
Study completion31 Oct 2024

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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06150430
Sponsor's protocol ID: Ortesi_Pelvica_Attiva_02
Status last verified: Jan 2025
First submitted: 13 Nov 2023
Last updated: 29 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Active Pelvis Orthosis (APO) for Post-stroke Gait Rehabilitation: a Pilot Study
ClinicalTrials.gov ID: NCT06150430
Acronym / sponsor ID: Ortesi_Pelvica_Attiva_02
Conditions: Stroke
Keywords: Hip exoskeleton, Cerebrovascular Disorders, Nervous System Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: IUVO S.r.l.Industry (pharma, biotech, devices)
Collaborators: Össur Iceland ehf, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Study start: 30 Mar 2023 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 29 Nov 2023 (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.

Detailed description

The primary objective of this study is to evaluate the safety, reliability and short-term effectiveness of APO-based training to increase the self-selected walking velocity (SSV) of stroke patients. The endpoint to evaluate the APO-based training effectiveness will be the difference in self-selected walking velocity (m/s) comparing post-training session (T4) to baseline sessions (T1\&T2).

Other objective of the study, both secondary and exploratory, have been defined to further investigate the effects of the IUVO APO on post-stroke subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Training with APO	Experimental	Device: APOAll participants are assigned to the training group with the APO

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

cerebral stroke;
at least 3 months from cerebral event;
hemiparesis;
age > 18 years;
SSV greater than 0.3 (m/s);

Key exclusion criteria (19 listed)

Modified Ashworth Scale >3 at the hip and/or ankle joints;
inability to follow verbal 3 step commands;
severe aphasia causing inability to communicate with the investigators;
serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures);
leg deep vein thrombosis less than 6 weeks ago;

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
APOSubjects will take part in 14 experimental sessions: two baseline sessions (T1-T2), three familiarization sessions (F1-F3), six training sessions (E1-E6), two assessment sessions (one pre-training T3 and one post training T4) and one 2-month follow-up session (T5). Depending on the session, the subject will walk with and/or without the APO. During the assessment sessions (T3-T4), the subject will be evaluated through different standard tests (such as 10MWTs and 2mWTs) and instrumented gait analysis, with and without the APO. The goal of each training session (E1-E6) will be to achieve a minimum of 30 minutes of overground walking assisted by the APO, leaving up to 15 minutes to rest if needed. Training sessions will occur 2-3 times a week for 2-3 weeks to complete the training protocol.	Device	Training with APO

Primary outcome

Incidence of Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)
Time frame: Duration of the study participation (estimated 4 weeks, excluding follow-up)
Safety of the device will be assessed by the number of ADEs and SADEs throughout the duration of the study
Incidence of Adverse Device Events (ADEs), Serious Adverse Device Events (SADEs) and Device Deficiencies (DDs)
Time frame: Duration of the study participation (estimated 4 weeks, excluding follow-up)
Reliability of the device will be assessed by the number of ADEs, SADEs and DDs throughout the duration of the study
10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)
Time frame: Baseline, Post-Training (estimated 3-4 weeks)
Change in SSV measured without the device

5 secondary outcomes

10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Time frame: Baseline, Post-Training (estimated 3-4 weeks)
10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
2-minute Walk Test (2mWT)
Time frame: Baseline, Post-Training (estimated 3-4 weeks)
2-minute Walk Test (2mWT)
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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. This study is not recruiting at the moment.

Franco Molteni, MD principal investigator

Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing APO in people with Stroke, run by IUVO S.r.l. 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 29 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs) (time frame: Duration of the study participation (estimated 4 weeks, excluding follow-up)). 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?

On the ClinicalTrials.gov record for NCT06150430.

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 29 Jan 2025.