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NCT06150430Completed

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
13 Nov 2023
Start date
30 Mar 2023
Primary completion date
31 Oct 2024
Lead sponsor
IUVO S.r.l.
Diseases
Stroke
NCT number
NCT06150430

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 30 Mar 2023 to the primary completion date, 31 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • major orthopedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine);
  • 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.

Other illness

  • 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);
  • skin wounds, infection or problems at device contact locations;
  • cardiac surgery within the last 3 months;
  • implanted cardiac devices (pacemakers, ICDs);

Other

  • 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;
  • Severe osteoporosis;
  • severe hip / knee osteoarthritis with limitation of movement or significant pain;
  • use of a colostomy bag;
  • patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention;
  • pregnancy;
  • breastfeeding woman;
  • use of assistive device that, in the PI's opinion, could interfere with APO;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta
Coordinator of this site? Confirm its status
LeccoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.