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.
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 endpoint to evaluate the APO-based training effectiveness will be the difference in self-selected walking velocity (m/s) comparing post-training session (T4) to baseline sessions (T1\&T2). Other objective of the study, both secondary and exploratory, have been defined to further investigate the effects of the IUVO APO on post-stroke subjects. The Investigational Device, Active Pelvis Orthosis RT v3.1 (APO), is a bilateral powered robotic hip orthosis (or exoskeleton) designed to gently assist hip flexion-extension movements by providing smooth assistive torque at the hip level, automatically adapting to natural gait variations. The study will be an interventional single-arm clinical trial with no control group and will involve up to 20 subjects, that fulfil the inclusion/exclusion criteria. This should be sufficient to provide the input needed to reach the primary and secondary objectives of the trial. In the protocol, after the screening visit, 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 be asked to walk with or without the APO, or both. During the assessment sessions, the subject will be evaluated through different standard tests (such as 10MWTs and 2mWTs) and instrumented gait analysis, with and without APO. In the training sessions, the subject will perform some overground walking practice with APO.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Ente Ospedaliero Valduce - UOC di Medicina Riabilitativa Villa Beretta
Lecco, Italy
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
Time frame: 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
Time frame: 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
Time frame: Baseline, Post-Training (estimated 3-4 weeks)
10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Change in FV measured without the device
Time frame: Baseline, Post-Training (estimated 3-4 weeks)
10-Meter Walk Test (10MWT) at Self-Selected walking Velocity (SSV)
Change in SSV measured without the device
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
10-Meter Walk Test (10MWT) at Fast walking Velocity (FV)
Change in FV measured without the device
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)
2-minute Walk Test (2mWT)
Change in walking endurance measured without the device
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Time frame: Baseline, Post-Training (estimated 3-4 weeks)
2-minute Walk Test (2mWT)
Change in walking endurance measured without the device
Time frame: Post-Training (estimated 3-4 weeks), Follow-up (2 months follow up)