Status:
COMPLETED
An Active Pelvis Orthosis (APO) for Post-stroke Gait Rehabilitation: a Pilot Study
Lead Sponsor:
IUVO S.r.l.
Collaborating Sponsors:
Össur Iceland ehf
Scuola Superiore Sant'Anna di Pisa
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
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. T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06150430
Start Date
March 30 2023
End Date
October 31 2024
Last Update
January 29 2025
Active Locations (1)
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1
Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta
Lecco, Italy, 23845