Home-based RehabilitationRECOVERYFUNNCT06640452
RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
A study testing RecoveryFun system in people with Home-based Rehabilitation and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Home-based Rehabilitation, Older People
- What is being tested?
- RecoveryFun system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2024to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Home-based Rehabilitation, Older People
- Being tested
- RecoveryFun system
- Keywords
- app, virtual reality, technology-integrated rehabilitation, tele-rehabilitation platform
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoveryFun systemOther
The system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services.
| Study group | Role | What they receive |
|---|---|---|
| older adults | Experimental | 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. Receives: Other: RecoveryFun system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 4 weeks of home-rehabilitation with RecoveryFun system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Mar 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Home-based RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640452
- Sponsor's protocol ID
- INRCA_004_2024
- Acronym
- RECOVERYFUN
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40729692
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVERYFUN: An Integrated VR-based Tele-rehabilitation Platform to Support RECOVERY and Maintenance of FUNctional Abilities Among Seniors
- ClinicalTrials.gov ID
- NCT06640452
- Acronym / sponsor ID
- RECOVERYFUN / INRCA_004_2024
- Conditions
- Home-based Rehabilitation, Older People
- Keywords
- app, virtual reality, technology-integrated rehabilitation, tele-rehabilitation platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, European Commission
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older adults | Experimental | Other: RecoveryFun systemThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecoveryFun systemThe system components were: VR headset; wereable biosensors, clinical platform, caregiver app and smart services. | Other | older adults |
Primary outcome
Usability of the RecoveryFun system
Time frame: after 4 weeks of home-rehabilitation with 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.
Acceptability of the RecoveryFun system
Time frame: after 4 weeks of home-rehabilitation with 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40729692Benadduci 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.
Related trials for Home-based Rehabilitation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Active, not recruiting
REACT - Resistance Exercise After Cancer Treatment
Cancer
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveryFun system in people with Home-based Rehabilitation and Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the RecoveryFun system (time frame: after 4 weeks of home-rehabilitation with RecoveryFun system). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.