Virtual Reality Software for Patients With Stroke

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 26

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 26

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 26

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 26

Lower extremity function (Berg Balance Scale)

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.

Time frame: Changes from baseline to weeks 13 and 26

Lower extremity function (Time Up and Go test)

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.

Time frame: Changes from baseline to weeks 13 and 26

Cognitive function

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.

Time frame: Changes from baseline to weeks 13 and 26

Cognitive function

The Trail-Making Test will be used to assess the executive function. Successful performance of this test requires letter and number recognition, mental flexibility, visual scanning, and motor function. The Part A consists of 25 circles with the numbers 1-25 written randomly in the circles. The participant is required to connect the circles with a pencil as quickly as possible (i.e. number one to number two, etc). The Part B of the test consists of 25 circles, 13 of them numbered 1 to 13 and, and 12 lettered A to L, randomly distributed over a page of paper. The participant is required to connect the circles with a pencil as quickly as possible, alternating between numbers and letters and taking both series in ascending sequence (i.e. 1, A, 2, B, 3, C…). The time taken to complete the task and the number of errors are recorded in seconds. Greater time indicates greater impairment.

Time frame: Changes from baseline to weeks 13 and 26

Plasma concentrations of inflammatory markers

Interleukin 2, 4, 6, 8, 10 (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

BDNF quantification in blood

Change in Brain-derived neurotrophic factor (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

GDNF quantification in blood

Change in Glial cell line-derived neurotrophic factor (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

PACAP-38 quantification in blood

Change in Pituitary Adenylate Cyclase-Activating Polypeptide-38 (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

Plasma concentrations of inflammatory markers, quantification in blood

Change in Tumor necrosis factor (TNF-alpha) (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

IGF-1 quantification in blood

Change in Insulin-Like Growth Factor-1 (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26

NGF quantification in blood

Change in Nerve Growth Factor (ng/mL)

Time frame: Changes from baseline to weeks 13 and 26