Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05280587
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2022-02-25
Brief Title:
Technological Balance and Gait Rehabilitation in Patients With Stroke Sequelae Functional Motor and Cognitive Outcomes
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Riabilitazione Tecnologica DellEquilibrio e Del Cammino in Pazienti Con Esiti di Ictus Effetti su Outcome Funzionale Motorio e Cognitivo ROAR-S
Status:
COMPLETED
Status Verified Date:
2023-02
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:
ROAR-S
Brief Summary:
Stroke represents the leading cause of disability worldwide with a significant impact on an individual family and economic impact The recovery of smoother safer and more correct walking is an essential requirement to allow the patient to regain autonomy in the activities of daily living Some preliminary studies have shown that robotic training of the gait training has influenced the functional and motor outcome in patients with stroke outcomes an improvement in endurance and walking strategies was observed In addition frequently a stroke involves an alteration of the cognitive system that contributes to the deterioration of balance and gait during dual-task activities the study of these processes can be of interest for rehabilitation purposes Considering these preliminary data and that the patient must continuously find balance in overground walking it is believed that a robotic balance treatment associated with conventional therapy may be more effective than conventional therapy alone Therefore this study aims to evaluate the effects of technological rehabilitation utilizing a robotic platform Hunova Movendo Technology srl Genova IT
i in terms of improvement in static dynamic balance and ambulation assessed with clinical scales and instrumental measures
ii on fatigue on cognitive performance in terms of sustained attention dual-task cost and cognitive-motor interference and on quality of life
i in terms of improvement in static dynamic balance and ambulation assessed with clinical scales and instrumental measures
ii on fatigue on cognitive performance in terms of sustained attention dual-task cost and cognitive-motor interference and on quality of life
Detailed Description:
Twenty-four patients of both sexes will be recruited evaluated and treated at the Rehabilitation and Physical Medicine Clinic Fondazione Policlinico Universitario A Gemelli IRCCS of Rome from Febraury 2022 to January 2023 Patients will be divided into two groups by randomization described below one group experimental group GH will perform specific rehabilitation for the balance disorder using the robotic platform Hunova Movendo Technology srl Genova IT 3 times a week for 4 weeks 12 total sessions for 45 minutes of treatment in addition to the conventional treatment conventional treatment and one group will perform only the conventional treatment conventional group GC as per daily routine as described later
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?:
None
Is an FDA AA801 Violation?:
None