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

NCT06150430 | Completed

• 1 other identifier: Ortesi_Pelvica_Attiva_02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

Hip exoskeleton; Cerebrovascular Disorders; Nervous System Diseases

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Baseline, Post-Training (estimated 3-4 weeks)

Secondary Outcomes (5)

• 10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)

  Baseline, Post-Training (estimated 3-4 weeks)

• 10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)

  Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)

• 10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)

  Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)

• 2-minute Walk Test (2mWT)

  Baseline, Post-Training (estimated 3-4 weeks)

• 2-minute Walk Test (2mWT)

  Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)

Study Arms (1)

Training with APO

EXPERIMENTAL

All participants are assigned to the training group with the APO

Device: APO

Interventions

APO DEVICE

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.

Training with APO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• IUVO S.r.l.: lead
• Össur Iceland ehf: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta

Lecco, 23845, Italy

Location

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Franco Molteni, MD

  Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 29, 2023
• Study Start: March 30, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)