Clinical trial NCT06640452: RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
Official title: RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Home-based Rehabilitation
Older People
Keywords: app
virtual reality
technology-integrated rehabilitation
tele-rehabilitation platform
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
name: European Commission
First posted: 2024-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

* No more than 12 months from acute event (for example stroke or brain injury)
* Trunk Impairment Scale (TIS) ≥20
* Fugl-Meyer Assessment Upper Extremities: Motor function for upper extremities (section A-D): a minimum Score of ≥33 is requested.

Exclusion Criteria:

* Technical Requirements based on the safety manual of the "Pico" headset
* Presence of pathology that could impact on the ability of using VR system or can be worsened by the use of VR system
* Montreal Cognitive Assessment (MoCA) score \<24

Primary outcomes:
measure: Usability of the RecoveryFun system
timeFrame: after 4 weeks of home-rehabilitation with RecoveryFun system
measure: Acceptability of the RecoveryFun system
timeFrame: after 4 weeks of home-rehabilitation with RecoveryFun system
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References: