Transcutaneous Electrical Nerve Stimulation (TENS) Over Acupoints (Acu-TENS) for Improving Sleep Quality, Cognitive Function, Motor Function and in Post-stroke Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
NOT_YET_RECRUITING
Hong Kong
The Hongkong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Shamay Ng, PhD
Shamay.Ng@polyu.edu.hk
27664889
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 70
Treatments
Experimental: Acu-TENS+SHP
The 120z Dual-Channel TENS Unit (ECS300A; Neurotrac, Verity Medical LTD, Ireland) will be used to stimulate the selected acupoints. The electrode will be placed over the acupoints and connected to the TENS stimulator. The stimulation frequency will be set at 100 Hz with a pulse width of 0.2 ms. Participants will also receive a set of instructions relating to SHP. SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. Participants will be instructed to read the guide after the baseline assessment (T0).
Sham_comparator: Sham Acu-TENS+SHP
Participants will receive similar treatment as Acu-TENS groups via identical-looking TENS devices with the electrical circuit disconnected.Participants will also receive a set of instructions relating to SHP. SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. Participants will be instructed to read the guide after the baseline assessment (T0).
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov