Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640452
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
RECOVERYFUN An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RECOVERYFUN An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVERYFUN
Brief Summary:
The scope of the RecoveryFun study is to test a new personalised home rehabilitation solution to leverage the telehealth paradigm and increase the possibility for seniors to perform remotely supervised home-rehabilitation
Detailed Description:
This study was designed to test the usability and acceptability of the RecoveryFun system by a group of subjects aged 60 years or older within one year after an acute event with upper limb hemiplegia Fugl- Meyer 33 The patient once the acute and intensive phase of rehabilitation is over should also continue from home the process begun However this often creates difficulties for the patient The study was carried out at the three recruitment sites ZURZACH Care TRAINM and INRCA
The study was structured in two phases
A pilot in protected environment
A trial with the system used at the patients home The inclusionexclusion criteria for the two steps were the same and the tools used to evaluate the result were the same too
The two phases had different specific objectives and to avoid any bias due to previous experience the participants recruited in the two phases were different
The RecoveryFun system comprehended Three tools a Virtual reality headset for rehabilitation purposes a set of Exergames and an app installed on caregivers smartphone to motivate and support the end user in the therapy The clinical personnel had access to the Clinical platform provided as a secured web app The system administrator could differentiate access rights to each clinical user group eg doctors physiotherapists nurses An Innovative biosensing wireless sensor wristband was integrated in the connected ecosystem to measure physiological parameters Heart Rate and Electrodermal Activity of end users during the rehabilitation session The patient performed the rehabilitation session according to the rehabilitation plan defined by the clinician To have coherent results the rehabilitation plan included at least two weekly rehabilitation sessions lasting between 10 and 30 minutes with the support of the caregiver if necessary Each session was planned and scheduled by the therapist remotely via the dedicated clinical platform
After 4 weeks the assessment of usability and acceptability of the RecoveryFun system were performed by validated tools
The study was structured in two phases
A pilot in protected environment
A trial with the system used at the patients home The inclusionexclusion criteria for the two steps were the same and the tools used to evaluate the result were the same too
The two phases had different specific objectives and to avoid any bias due to previous experience the participants recruited in the two phases were different
The RecoveryFun system comprehended Three tools a Virtual reality headset for rehabilitation purposes a set of Exergames and an app installed on caregivers smartphone to motivate and support the end user in the therapy The clinical personnel had access to the Clinical platform provided as a secured web app The system administrator could differentiate access rights to each clinical user group eg doctors physiotherapists nurses An Innovative biosensing wireless sensor wristband was integrated in the connected ecosystem to measure physiological parameters Heart Rate and Electrodermal Activity of end users during the rehabilitation session The patient performed the rehabilitation session according to the rehabilitation plan defined by the clinician To have coherent results the rehabilitation plan included at least two weekly rehabilitation sessions lasting between 10 and 30 minutes with the support of the caregiver if necessary Each session was planned and scheduled by the therapist remotely via the dedicated clinical platform
After 4 weeks the assessment of usability and acceptability of the RecoveryFun system were performed by validated tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None