Completed

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

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What is being tested

APO

Device
Who is being recruted

Brain Diseases+4

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorIUVO S.r.l.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 30, 2023

Actual date on which the first participant was enrolled.

The study is focused on helping stroke patients improve their walking speed by using a special device called the Active Pelvis Orthosis (APO). This device is a type of robotic exoskeleton that supports the hips and helps with walking motions. The main goal is to see if this device can safely and effectively increase the natural walking speed of stroke survivors. Understanding whether the APO can enhance walking speed is important because it could provide a new way to support rehabilitation and improve the quality of life for those affected by stroke. Participants in the study will attend multiple sessions where they will practice walking with the APO. The sessions include initial baseline assessments, a few practice sessions to get used to the device, and dedicated training sessions. The effectiveness of the APO will be measured by comparing walking speed before and after the training. Participants' walking abilities will be evaluated using standard walking tests and gait analysis, both with and without the device. This structured approach ensures the study thoroughly assesses the potential benefits and any safety concerns associated with using the APO for rehabilitation.

Official TitleAn Active Pelvis Orthosis (APO) for Post-stroke Gait Rehabilitation: a Pilot Study
NCT06150430
Principal SponsorIUVO S.r.l.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

8 inclusion criteria required to participate
cerebral stroke;

at least 3 months from cerebral event;

hemiparesis;

age > 18 years;

Show More Criteria

19 exclusion criteria prevent from participating
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);

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants are assigned to the training group with the APO

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta

Lecco, ItalyOpen Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta in Google Maps
CompletedOne Study Center