None listed
Conditions
Brief summary
The 36 Acute stroke survivors with impairments of upper limb (definite diagnosis of stroke that occurred within 1 month) will be randomized to either the intervention or the control group using block randomization. A computer-generated random number sequence will be created by an independent investigator with random block sizes of four, six and eight, in order to ensure similar size among the groups. Treatment allocation will be concealed in sealed, opaque envelopes and stored in a secure location. To prevent bias, assessors will be blind to group allocation. And data analysis will be undertaken by a statistician who is blind to group allocation. Intervention group will be equipped with Online Rehab Virtual Assistant (ORVA) for their home exercise in addition to standard treatment received in Hospital. Intervention will be performed twice a week for continuous 12 weeks. Control will undergo standard physiotherapy treatment protocol in hospital setting and standard home-based exercise. Primary outcome of this study will be upper limb motor function (strength, movement, coordination, and reflex action). Baseline measurements of the entire participant in both groups will be measured again after 6 weeks of intervention, on 7th week, and after 12 weeks, on 13th week. We hypothesise that the remotely monitored virtual reality gaming will be effective to improve upper limb function in stroke survivors
Interventions
Intervention group will be equipped with Online Rehab Virtual Assistant (ORVA) for their home exercise in addition to standard treatment received in Hospital. Intervention will be performed around 30-40 minutes per session, 5 times a week for continuous 12 weeks.
ORVA is a remotely monitored system virtual reality. An application will be install in participant's or career's smartphone or tablet. Then, participants will be equipped with wrist/arm mounting strip, a micro USB cable, an Infrared (IR
Intervention group will be equipped with Online Rehab Virtual Assistant (ORVA) for their home exercise in addition to standard treatment received in Hospital. Intervention will be performed around 30-40 minutes per session, 5 times a week for continuous 12 weeks. ORVA is a remotely monitored system virtual reality. An application will be install in participant's or career's smartphone or tablet. Then, participants will be equipped with wrist/arm mounting strip, a micro USB cable, an Infrared (IR) sensor, and a Bluetooth Low Energy (BLE) dongle. Next, the participants and their career will attend a 1-hour briefing by the research team at the hospital before commencing the home exercises. The ORVA games that will be used for Intervention group comprised of 3 virtual games for upper limb exercise: 1) Cube and Hole, 2)Catching and 3) Fishing. All of the games required large cursor movements in both the horizontal and vertical direction to stimulate movement of upper extremities. There are different levels of difficulty which can be set by the therapist based on participants' progress. All the progression will be assessed through the system which is connected to the application and also by the physiotherapist in the hospital.
Sponsors
PicoSys SDN BHD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
i) Acute stroke survivors with impairments of upper limb (definite diagnosis of stroke that occurred less than or equal to 1 month) ii) Adults with stroke (participants had to be greater than or equal to 18 years old) iii) Adults with stroke who can participate in the virtual reality games intervention program without limitation (presently with good health and no self-reported orthopaedic, medical or painful conditions). iv) Adults with stroke who are able to provide written informed consent.
Exclusion criteria
i) Adults with stroke who have severe cognitive impairments and inability to understand the project and its requirements e.g. dementia and receptive aphasia (Mini Mental State Examination score less than 17). ii) Adults with stroke who are taking any prescribed drugs that could potentially affect physical function and balance such as corticosteroids, antipsychotic or antidepressants.
Outcome results
None listed