Actively Recruiting
Acu-TENS to Improve the Sleep Quality in People with Stroke
Led by The Hong Kong Polytechnic University · Updated on 2024-10-03
70
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post-stroke sleep disorder and motor/cognitive dysfunction are common complications that affect the quality of life of older patients. The proposed study investigates the effects of an acupuncture-like method applied to six bilateral acupoints on sleep quality, motor function and cognition in older adults with chronic stroke. The study will be a single-blind (i.e., only patients will be blinded about the research purpose) randomized controlled trial (i.e., patients receiving the treatment is chosen at random) with a pre-mid-post follow-up design and involve two parallel groups of post-stroke survivors (aged \> 55 years) diagnosed with insomnia. Participants will be randomly allocated in a 1:1 radio to two independent groups, i.e., a treatment group or placebo group, namely a transcutaneous electrical nerve stimulation placed on acupoints (Acu-TENS) or a placebo group. The Acu-TENS group will receive a 6-week treatment that includes a 30-minute Acu-TENS + sleep hygiene program (SHP) twice a week. The placebo group will receive sham Acu-TENS (i.e., devices with the electrical circuit disconnected) + SHP with the same frequency as the Acu-TENS group. The selected acupoints will be bilateral Hegu (LI4), Quchi (LI11), Neiguan (PC6), Shenmen (HT7) on the arm and Sanyinjiao (SP6) and Zusanli (ST36) on the lower limb. The study's primary outcomes will be sleep quality measured by the device of ActiGraph and the self-report survey. The secondary outcomes will be motor function, measured by physical performance tests, cognition, measured by computer battery, and quality of life, measured by the self-report survey. All outcomes will be measured at the baseline assessment (before the treatment), mid-term assessment (after the three weeks treatment), post-treatment assessment (after the six-week treatment), and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia, improve cognition and motor function in participants than the sham Acu-TENS + SHP treatment.
CONDITIONS
Official 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 MRI or CT scan more than one year ago
- Able to walk 6 meters independently
- Mini-mental state examination score between 18 and 27
- Self-reported poor sleep quality with PSQI score of 6 or higher in the past four weeks
You will not qualify if you...
- Have a cardiac pacemaker
- Have a severe disease preventing Acu-TENS treatment
- 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
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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
CONTACT
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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