NOT YET RECRUITING
NCT06999876
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)
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
Gender: All
Ages: 21 Years - 79 Years
Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage