NCT06640452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 10, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

appvirtual realitytechnology-integrated rehabilitationtele-rehabilitation platform

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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.

Other: RecoveryFun system

Interventions

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

older adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

March 25, 2024

Primary Completion

July 24, 2024

Study Completion

July 24, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations