Stroke
Conditions
Keywords
stroke
Brief summary
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
Detailed description
Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. According to data from the World Health Organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. A stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. Therefore, improving the rehabilitation process is evidently of paramount significance. Virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. Therefore, the aim of RESET randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.
Interventions
DEVICEMETA QUEST 3 virtual reality glasses
The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.
DEVICENintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)
This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.
OTHERUsual care
The UC intervention consists of 3 sessions/week of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.
Sponsors
Ministerio de Ciencia e Innovación, Spain
European Union
Universidad de Almeria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Trunk control in seated and standing position * Ability to understand basic instructions and to decide whether to sign informed consent
Exclusion criteria
* 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 * Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition * A history of cerebrovascular disease (if not fully resolved) * Photosensitive epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability (The Barthel index) | Changes from baseline to weeks 13 and 26 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity) | Changes from baseline to weeks 13 and 26 | 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. |
| Gross manual dexterity (The Box and Block Test) | Changes from baseline to weeks 13 and 26 | 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. |
| Handgrip strength | Changes from baseline to weeks 13 and 26 | 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. |
| Lower extremity function (Berg Balance Scale) | Changes from baseline to weeks 13 and 26 | The Berg Balance Scale is a quantitative assessment of balance in older adults. The scale consists of 14 items requiring subjects to maintain positions or complete movement tasks (common to everyday life) of varying levels of difficulty. Items receive a score of 0-4 based on ability to meet the specific time and distance requirements of the test. 0 represents inability to complete the item and a 4 represents the ability to complete it independently. |
| Lower extremity function (Time Up and Go test) | Changes from baseline to weeks 13 and 26 | The Time Up and Go assesses the ability to perform sequential motor tasks relative to walking and turning. The test requires participants to stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and seat by themselves in the minimum timeframe possible. The time taken to complete the test is registered. |
| Cognitive function | Changes from baseline to weeks 13 and 26 | The Montreal cognitive assessment, MoCA, consists of 10 simple questions or tasks related to cognitive function. Typically, these are grouped into the following cognitive domains: short term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The total score ranges 0-30. Higher scores indicating better cognitive performance. |
| Quality of life (NEWSQOL) | Changes from baseline to weeks 13 and 26 | 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. |
| BDNF quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Brain-derived neurotrophic factor (ng/mL) |
| GDNF quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Glial cell line-derived neurotrophic factor (ng/mL) |
| PACAP-38 quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Pituitary Adenylate Cyclase-Activating Polypeptide-38 (ng/mL) |
| Plasma concentrations of inflammatory markers, quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Tumor necrosis factor (TNF-alpha) (ng/mL) |
| IGF-1 quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Insulin-Like Growth Factor-1 (ng/mL) |
| NGF quantification in blood | Changes from baseline to weeks 13 and 26 | Change in Nerve Growth Factor (ng/mL) |
| Plasma concentrations of inflammatory markers | Changes from baseline to weeks 13 and 26 | Interleukin 2, 4, 6, 8, 10 (ng/mL) |
Countries
Spain
Contacts
Primary ContactAlberto Soriano-Maldonado, PhD
Outcome results
None listed