- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928155
Inclusive Rehabilitation: Virtual Reality as a Tool to Improve the Quality of Life of Dependent Persons (REVIVIR)
Feasibility and Usability of Immersive Virtual Reality for People With Dependency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The world's population is aging rapidly. Globally, the number of people aged 80 years and older is projected to more than triple between 2017 and 2050, from 137 million to 425 million (1). Various studies have shown that the four most common health conditions in older adults are decreased motor skills, increased obesity, cognitive impairment, and psychological disorders, leading to lower quality of life (2, 3).
To combat this challenge, several emerging assistive technologies that improve quality of life in older populations have been explored, including Internet-based physical activity programs, gamification to improve physical activity [4], etc. Virtual reality (VR) is also an emerging technology with the potential to improve well-being and quality of life [5], muscle activity and balance, and physical activity [6], with evidence of beneficial effects on social, emotional states, and cognition [7].
VR offers a highly personalized virtual environment that allows exercises to be tailored to the specific needs of each patient. Users can practice movements in realistic and motivating scenarios, which increases their engagement and motivation during rehabilitation sessions. By allowing complex, customized movements to be simulated, VR facilitates the visualization and repeated practice of actions that, in the physical world, would be difficult or impossible to execute. This constant repetition stimulates the neural pathways associated with movements, promoting neuroplasticity and improving coordination and muscle strength.
Therefore, the purpose of this study is to describe the impact of the application of Immersive Virtual Reality on the mobility and anxiety levels of the participants, as well as to explain adherence, the presence of adverse effects and the usability of this tool.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raúl Romero del Rey, Doctor of Physiotherapy
- Phone Number: +34645127620
- Email: rrd239@ual.es
Study Locations
-
-
Andalucía
-
Almería, Andalucía, Spain, 04007
- Recruiting
- Asociación "El Saliente"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years of age
- Patients who agree to participate in the study and sign the informed consent form.
Exclusion Criteria:
- Those with severe visual impairment, vertigo, epilepsy or psychosis, and who may interfere with the normal performance of interactive voice response (IVR) tasks, will be excluded as a precaution.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The intervention group will receive immersive virtual reality sessions twice a week, for a total of 6 weeks, with sessions lasting no more than 30 minutes.
|
The intervention will be carried out with an immersive virtual reality device, specifically, with a head mounted display.
Specifically, it is the "MetaQuest 3" model.
|
|
Active Comparator: Control group
The control group will continue with their usual physiotherapy treatment, which includes aerobic exercises and strength training.
|
The combination of aerobic and strength training is part of the conventional physiotherapy treatment carried out at the center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety levels
Time Frame: At baseline, at 6 weeks and at 2 months.
|
Anxiety levels will be measured using the Generalized Anxiety Disorder (GAD-7).
|
At baseline, at 6 weeks and at 2 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence levels
Time Frame: At baseline, at 6 weeks and at 2 months
|
The level of adherence to the intervention will be measured by keeping a record of users who do or do not complete the sessions, in order to establish the dropout rate.
|
At baseline, at 6 weeks and at 2 months
|
|
Functional mobility
Time Frame: At baseline, at 6 weeks and at 2 months
|
Functional mobility will include the evaluation of gait and balance using the Tinetti scale (0-28 points).
|
At baseline, at 6 weeks and at 2 months
|
|
Ability to perform activities of daily living
Time Frame: At baseline, at 6 weeks and at 2 months
|
The ability to perform activities of daily living will be measured using the Barthel Index (0-100 points).
|
At baseline, at 6 weeks and at 2 months
|
|
Cognitive impairment
Time Frame: At baseline, at 6 weeks and at 2 months
|
Cognitive impairment will be measured using the Lobo Mini Cognitive Test.
|
At baseline, at 6 weeks and at 2 months
|
|
Usability/Acceptability
Time Frame: At 6 weeks and at 2 months
|
The usability or acceptability of the intervention will be measured with the Usability Scales System (SUS).
|
At 6 weeks and at 2 months
|
|
Feasibility/cybersickness
Time Frame: At 6 weeks and at 2 months.
|
The feasibility of the intervention will be measured according to the occurrence of adverse symptomatology associated with the use of virtual reality.
For this purpose, the "Simulator Sickness Questionnaire" (SSQ) will be used.
|
At 6 weeks and at 2 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TRFE-SI-2024/005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on People With Dependency
-
REGINA ALLANDE CUSSOCompletedOlder People | Social Exclusion | Care DependencySpain
-
Universidad de ZaragozaIngesan-OHLACompletedPeople 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive DependencySpain
-
Peking University People's HospitalRecruitingPeople With High Body Fat Percentage | People With High Visceral Fat AreaChina
-
University of GavleNot yet recruitingOlder People With Home Care | Staff Working With Older People in Home CareSweden
-
Chung Shan Medical UniversityCompleted
-
University of California, San DiegoRecruitingPeople Who Use Opioids/People With Opioid Use Disorder (OUD)United States
-
Chung Shan Medical UniversityRecruitingHuman Clinical Trial Evaluating the Blood Glucose-Regulating Effects of Momordica Charantia PeptidesPeople With PrediabeticTaiwan
-
Centre Mutualiste de Rééducation et de Réadaptation...CompletedPeople With Motor DisabilitiesFrance
-
University College, LondonCardiff UniversityNot yet recruiting
-
Centre Hospitalier Universitaire DijonRecruitingPeople With White Sutton SyndromeFrance
Clinical Trials on Immersive Virtual Reality with Head Mounted Display
-
Mansoura UniversityCompletedPain | Gastrointestinal Endoscopy | Procedural AnxietyEgypt
-
University of TorontoNot yet recruitingVirtual Reality | Surgical Education | Orthopaedic Training
-
Cairo UniversityRecruiting
-
University Hospital of FerraraIRCCS Centro Neurolesi Bonino Pulejo; Ospedale Accreditato Villa Bellombra; Casa...RecruitingSub-acute StrokeItaly
-
Qilu Hospital of Shandong UniversityNot yet recruiting
-
University of Vic - Central University of CataloniaHospital Vall d'Hebron; Consorci Hospitalari de Vic (CHV)Not yet recruitingStroke | Traumatic Brain Injury | Acquired Brain Injury Including Stroke | Unilateral Spatial Neglect (USN)Spain
-
University of Campania Luigi VanvitelliUniversity of Otago; University of Sydney; University of Bari Aldo MoroNot yet recruiting
-
Cairo UniversityRecruitingCardiorespiratory Fitness or EnduranceEgypt
-
University Health Network, TorontoCentre for Aging and Brain Health InnovationCompleted