Virtual Reality Software for Patients With Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Almeria
About this trial
The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.
The main questions it aims to answer are:
* To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke. * To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women and men with either an ischemic or hemorrhagic stroke
Stroke between the last 7 to 14 days
Functional independence before stroke (modified Rankin scale <3)
Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale
Disqualifiers
Moderate-severe aphasia that precludes understanding the required tasks
Cognitive impairment that precludes cooperation with tasks
Serious behavioral problems or mental disorders
Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction
Trial design
Design model
Parallel
Treatments tested in this trial
META QUEST 3 virtual reality glasses
DeviceThe RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.
Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)
DeviceThis group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.
Usual care
Other interventionThe UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Commercial non-immersive virtual reality group (CVR)Active comparator 1 intervention
Group B: Gamified, fully immersive and stroke-specific virtual reality group (RESET)Experimental treatment 1 intervention
Group C: Usual care (UC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disability (The Barthel index)
An ordinal scale used to measure performance in activities of daily living. It consists of 10 common activities, with eight of them representing activities related to personal care and 2 related to mobility. These are assessed for independence/dependence and scored via an arbitrary weighting system- the index yields a total score out of 100 - the higher the score, the lower degree of disability.
Time frame
Changes from baseline to weeks 13 and 26Secondary outcomes
1
Quality of life (NEWSQOL)
The Newcastle Stroke-Specific Quality of Life Measure assess the specific health-related quality of life measure of 56 items grouped into 11 domains: feelings; ADL/self-care; cognition; mobility; emotion; sleep; interpersonal relationships; communication; pain/sensation; vision; and fatigue. Each item is rated in range 0 to 3, and they are not significant individually. The results of each domain are obtained by the sum of the scores of the items, and higher values indicate greater impact on quality of life.
Time frame
Changes from baseline to weeks 13 and 262
Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)
The test consists of 33 items that evaluate the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. Each item is scored on a 3-point scale (0=cannot perform, 1=performs partially, 2=performs fully) and the total score ranges from a minimum of 0 (hemiplegia) to a maximum of 66 points.
Time frame
Changes from baseline to weeks 13 and 263
Gross manual dexterity (The Box and Block Test)
The participant is seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. A total of 150 colored, wooden cubes or blocks (2.5 cm) are placed in one compartment. The participant is instructed to move as many blocks as possible, one at a time, from one compartment to the other for 60 seconds. The score is the number of blocks moved from one compartment to the other during the trial time. The patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time, count as a single point. Higher scores on the test indicate better gross manual dexterity.
Time frame
Changes from baseline to weeks 13 and 264
Handgrip strength
Digital dynamometry will be used to assess the muscular strength in kilograms of both the affected and non-affected upper extremities.Participants will execute the test three times with each hand and the best score will be used to calculate the average of the three repetitions. The non-paretic side will be used as a reference for the paretic side.
Time frame
Changes from baseline to weeks 13 and 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de Almeria
Lead sponsor
Ministerio de Ciencia e Innovación, Spain
Collaborator
European Union
Collaborator
Source ClinicalTrials.gov