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The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia (COMPENSATOR-Stroke)
Sponsor: National University Health System, Singapore
Summary
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
Official title: The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia: A Double-blind, Sham-controlled, Randomized Controlled Study
Key Details
Gender
All
Age Range
21 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-05-31
Completion Date
2026-12-31
Last Updated
2025-05-31
Healthy Volunteers
No
Interventions
The AscenZ-VIII Stimulator (Investigational Medical Device)
Sham 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)
This 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.
Locations (2)
National University Hospital
Singapore, Singapore, Singapore
Alexandra Hospital
Singapore, Singapore, Singapore