Trials / Completed
CompletedNCT06640452
RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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 patient's home. The inclusion/exclusion 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 caregiver's 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 (e.g: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | RecoveryFun system | The system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services. |
Timeline
- Start date
- 2024-03-25
- Primary completion
- 2024-07-24
- Completion
- 2024-07-24
- First posted
- 2024-10-15
- Last updated
- 2024-10-15
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06640452. Inclusion in this directory is not an endorsement.