Acu-TENS to Improve the Sleep Quality in People with Stroke
Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, Motor Function and in Post-stroke Patients
The Hong Kong Polytechnic University
70 participants
Dec 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- aged between 55 and 85 yrs;
- diagnosed with stroke by magnetic resonance imaging or computed tomographic scan longer than one year;
- able to walk 6-m independently;
- scored ≥18 but less or equal than 27 in mini-mental state examination (MMSE);
- self-reported poor sleep quality (PSQI, scores ≥ 6) in the past four weeks.
Exclusion Criteria5
- have a cardiac pacemaker;
- have a severe disease that precludes the receipt of Acu-TENS;
- are taking medication that may affect measured outcomes;
- have skin lesions, infection, or inflammation near selected acupoints;
- are participating in other drug/treatment programs.
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Interventions
A dual-channel TENS stimulator will be used (ECS300A; Neurotrac, Verity Medical LTD, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.
A dual-channel TENS stimulator will be used (ITO Physiotherapy \& Rehabilitation, Co, Ltd, Tokyo, Japan). Electrodes will be placed over selected acupoints (i.e., bilateral Sanyinjiao (SP6), Neiguan (PC6), Shenmen (HT7), Hegu (LI4), Zusanli (ST36) and Quchi (LI11)) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05623137