Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150430
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-13
Brief Title:
An Active Pelvis Orthosis APO for Post-stroke Gait Rehabilitation a Pilot Study
Sponsor:
IUVO Srl
Organization:
IUVO Srl
Study Overview
Official Title:
An Active Pelvis Orthosis APO for Post-stroke Gait Rehabilitation a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 v31 IUVO APO developed bu IUVO Srl
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 The endpoint to evaluate the APO-based training effectiveness will be the difference in self-selected walking velocity ms comparing post-training session T4 to baseline sessions T1T2
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 v31 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 inclusionexclusion 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
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 v31 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 inclusionexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None