RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors (RECOVERYFUN)

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.

Study Overview

• Status: Completed
• Conditions: Older People; Home-based Rehabilitation
• Intervention / Treatment: Other: RecoveryFun system

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60127
    • IRCCS INRCA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: older adults; The population concerned of patients who has overcome an acute event and completed intensive inpatient rehabilitation. The patient we are referring to has already returned home and needed to maintain the goals achieved or increase functionality.	Other: RecoveryFun system; The system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the RecoveryFun system	The usability was assessed by the System Usability Scale (SUS). The SUS is a 10 item questionnaire with 5 response options.It generates a quantifiable measure called the SUS score, which ranges from 0 to 100, with zero being the least and 100 being the maximum.	after 4 weeks of home-rehabilitation with RecoveryFun system
Acceptability of the RecoveryFun system	The acceptability was assessed by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). The QUEST is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. The questionnaire consists of 12 satisfaction items.	after 4 weeks of home-rehabilitation with RecoveryFun system

Collaborators and Investigators

• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
• Collaborators: European Commission; Ministry of Health, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: virtual reality; app; technology-integrated rehabilitation; tele-rehabilitation platform
• Other Study ID Numbers: INRCA_004_2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No