Actively Recruiting
Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, and Motor Function in Post-Stroke Patients
Led by The Hong Kong Polytechnic University · Updated on 2024-10-03
70
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a non-invasive acupuncture-like method called transcutaneous electrical nerve stimulation at acupoints (Acu-TENS) combined with a sleep hygiene program (SHP) on sleep quality, motor function, cognition, and quality of life in older adults who have had a stroke and suffer from chronic insomnia. This single-blind, randomized controlled trial includes participants aged 55 to 85 years with a diagnosis of stroke lasting more than one year and self-reported poor sleep quality. The study aims to provide high-quality data on the effectiveness of Acu-TENS for treating post-stroke sleep disorders and related dysfunctions. Participants will be randomly assigned to one of two groups: the treatment group receiving Acu-TENS plus SHP or the placebo group receiving sham Acu-TENS plus SHP. The Acu-TENS treatment involves placing electrodes on six bilateral acupoints on the arms and lower limbs, delivering mild electrical stimulation twice a week for six weeks, with each session lasting 30 minutes. Both groups receive the sleep hygiene program, which includes guidance on healthy sleeping habits. The placebo group uses identical devices with the electrical circuit disconnected. Throughout the study, participants will undergo assessments at baseline, mid-treatment (three weeks), post-treatment (six weeks), and follow-up (two weeks after treatment ends). These assessments measure sleep quality using both devices and self-reported surveys, motor function through physical performance tests, cognitive function via computer-based tests, and quality of life through surveys. Safety and treatment adherence will be monitored, with careful observation of participant progress during and after the treatment period, which lasts a total of eight weeks including follow-up.
CONDITIONS
Brief Title
Acu-TENS to Improve the Sleep Quality in People with Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 55 and 85 years
- Diagnosed with stroke by magnetic resonance imaging or computed tomographic scan more than one year ago
- Able to walk 6 meters independently
- Scored 18 to 27 in Mini-Mental State Examination (MMSE)
- Self-reported poor sleep quality with Pittsburgh Sleep Quality Index (PSQI) score 6 or higher in the past four weeks
You will not qualify if you...
- Have a cardiac pacemaker
- Have a severe disease that prevents receiving Acu-TENS
- Taking medication that may affect study outcomes
- Have skin lesions, infection, or inflammation near selected acupoints
- Participating in other drug or treatment programs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive Acu-TENS or sham stimulation on selected acupoints combined with a sleep hygiene program to improve sleep quality, motor function, and cognition. The stimulation sessions last 30 minutes each and occur regularly over the treatment period.
Twice weekly visits for 4 weeks
Duration - 2 weeks
Participants are monitored after treatment to assess sustained effects on sleep quality, motor function, cognition, and quality of life.
1 visit (in-person) at 6 weeks post-baseline
Trial Site Locations
Total: 2 locations
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Not Yet Recruiting
2
The Hongkong Polytechnic University
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Shamay Ng, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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