MedTrace Logo

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

NCT06150430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

APO

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.

Sponsors & Collaborators

  • Össur Iceland ehf

    collaborator INDUSTRY

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • IUVO S.r.l.

    lead INDUSTRY

Principal Investigators

  • Franco Molteni, MD · Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150430 on ClinicalTrials.gov