Grounding Effect on Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-07-31

Brief Summary

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The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.

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Detailed Description

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Grounding refers to having direct contact with the Earth, such as walking barefoot or lying on the ground. Research has found that grounding can improve inflammation, free radical damage, blood pressure, sleep quality, pain, stress, mood, and wound healing. However, there has been no re-search on the effect of utilizing grounding for patients with Alzheimer's disease (AD). Thus, in this study, the investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.

Patients with mild AD were enrolled in the study. The electrochemical analyzer CHI 1205b was employed to check the electrochemical signals at acupoints KI1 and GV16. The investigators used the Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II (BDI-II) to evaluate sleep quality, anxiety, and depression, respectively, at weeks 0 and 12.

Conditions

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Alzheimer Disease Insomnia Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The investigators use a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. The patients are blinded to the grounding because they do not know which one has a grounding effect according to the exterior of the mat.

The investigators who do the evaluation of questionnaire and electrochemical analyzer and the outcomes assessor who interpret the data do not know which wire has grounding effect, too.

Study Groups

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Patient receive grounding

The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The grounding group use a grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.

Group Type EXPERIMENTAL

Grounding

Intervention Type DEVICE

The investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat.

Patient receive sham-grounding

The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The sham-grounding group use a sham grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.

Group Type SHAM_COMPARATOR

Grounding

Intervention Type DEVICE

The investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat.

Interventions

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Grounding

The investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosed with dementia, and CDR ≥ 0.5
* aged \> 50 years,
* sit with bilateral bare feet on the grounding mat
* able to answer the questionnaire
* able to sign the informed consent adequately.

Exclusion Criteria

* aged less than 50 years
* inability to sit with bilateral bare feet on the grounding mat
* currently taking anti-oxidative health supplements or anti-inflammatory medicine.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No