The goal of this study is to evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery in stroke patients with hemiplegia or hemiparesis in the subacute stage.The main questions it aims to answer are:
Primary objective - To evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery, in stroke patients with hemiplegia or hemiparesis in the subacute stage
Secondary Objectives -
1. To evaluate the effects of high frequency tPCS + TENS in treatment of lower limb spasticity related to stroke. 2. To evaluate the effects of high frequency tPCS + TENS in gait function improvement post stroke, including walking speed, mobility, balance and walking endurance. 3. To evaluate the effects of high frequency tPCS on pain, mood and QOL.
Researchers will compare the effects of high frequency tPCS + TENS to a control group which involves intervention with Sham device stimulation + TENS.
Participants will:
* Be identified, recruited and have baseline assessments during screening period * First undergo a mandatory 2-hour device training at Visit 2 to ensure device competence. * Proceed with up to 7 days of habituation for device use and tolerability. * Carry out daily intervention sessions of 30 minutes for 30 days at home or inpatient setting. * Phone call follow-up (Telephone/ Video Call Interview) 2 weeks post intervention * Clinic visit at day 30 post intervention with allowance of + 7 days for study assessments * Clinic visit at day 90 post intervention with allowance of +/- 7 days for study assessments * Update study coordinators via messaging platforms with regards to device issues, adverse events, any other reporting or questions
Participants aged 21 years old and below 80 years old with a clinically diagnosed first onset ischaemic stroke confirmed by imaging modalities such as computerised tomography (CT) or magnetic resonance imaging (MRI). Previous transient ischemic attack or clinically silent infarct detected by CT/MRI are not considered as previous stroke.
Participants within the subacute stage of stroke (Within 14 days from stoke onset)
Able to walk with or without assistance
Able to understand instructions and give informed consent
History of craniotomy or placement of implant materials/ device in the body that may affect NIBS including, but not limited to, deep brain stimulator, cardiac implant, cochlear implant
Intracranial haemorrhage in the cortical regions
History of epilepsy or seizures
History of major depression and a history of psychotic disorders
Parallel
The AscenZ-VIII Stimulator (Investigational Medical Device)
DeviceSham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.
The AscenZ-VIII Stimulator (Investigational Medical Device)
DeviceThis group will receive active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via 6\*9cm Silica gel electrodes on top of the tPCS that is delivered through Channel 1. The placement of the electrodes will be on the part of the spinal segment innervating the lower limbs (L1-L5), the adductor muscles and the gastrocnemius muscles.
Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA)
Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA). Mean change in LE-FMA from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Functional Independence Measure (FIM)
Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in functional independence measured using Functional Independence Measure (FIM) score, in stroke patients with hemiplegia or hemiparesis in the subacute stage. Mean change in FIM from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Modified Ashworth Scale (MAS)
Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in lower limb spasticity related to stroke objectively measured using Modified Ashworth scale (MAS). Mean change in MAS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Modified Tardieu Scale (MTS)
Effects of high frequency tPCS + TENS compared to Sham device stimulation +TENS (Control) in treatment of lower limb spasticity related to stroke objectively measured using Modified Tardieu Scale (MTS).. Mean change in MTS from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
Time Up and Go (TUG)
Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking speed, objectively measured with Time Up and Go (TUG). Mean change in TUG from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
10-meter Walk Test (10MWT)
Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in walking endurance objectively measured with 10-meter Walk Test (10MWT). Mean change in 10MWT from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days), and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).
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