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

NCT ID: NCT06640452

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2024-07-24

Brief Summary

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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

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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

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Home-based Rehabilitation Older People

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RecoveryFun system

Intervention Type OTHER

The system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services.

Interventions

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RecoveryFun system

The system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

European Commission

OTHER

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS INRCA Hospital

Ancona, , Italy

Site Status

Countries

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Italy

References

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Benadduci M, Franceschetti C, Marziali RA, Frese S, Sandor PS, Tombolesi V, Bozzi V, Rossi L. An Integrated Virtual Reality-Based Telerehabilitation Platform to Support Recovery and Maintenance of Functional Abilities Among Older Adults: Protocol for a Usability and Acceptability Study. JMIR Res Protoc. 2025 Jul 29;14:e68358. doi: 10.2196/68358.

Reference Type DERIVED
PMID: 40729692 (View on PubMed)

Other Identifiers

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INRCA_004_2024

Identifier Type: -

Identifier Source: org_study_id

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