Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort

NCT04025619 | Completed

• 1 other identifier: GreenE2017
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Special metals (e.g. Germanium, Titanium, and π element) can be used to produce far-infrared radiation. The applications of these metals in promoting blood circulation are worth investigating. This clinical trial recruited subjects for using tape made up of Ge, Ti, and π element developed by Green Energy Nano Technology Co., Ltd. We assumed that the experimental tape can improve the participants' peripheral blood circulation and their quality of life. In this clinical trial, the clinical efficacy and safety of the test products were assessed using physical examination and questionnaires.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (3)

• Ankle-Brachial Pressure Index

  Detect the pressure difference in percentage between brachial pressure and ankle pressure by the pulse volume record and ultrasound device.

  1 day

• MVO/SVC

  The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)

  1 day

• Visual Analog Scale (VAS) Pain

  VAS is measurement instrument for describing pain severity or intensity. The pain scale is range from 0 to 10, representing "no hurt" to "hurt worst", respectively.

  1 day

Secondary Outcomes (1)

• Kidney Disease Quality of Life

  Day 0 (before intervention) and Day 7 (after using the intervention for 7 days)

Study Arms (2)

treatment group

EXPERIMENTAL

the data is collected from the same participant after the intervention.

Device: tape

Control group

NO INTERVENTION

The Collect the data from the same participant before the intervention as control

Interventions

tape DEVICE

Sports tape

treatment group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiovascular disease (deep Vein Thrombosis or Chronic venous insufficiency)

You may not qualify if:

• Vulnerable populations
• wound at lower limb which can not take the intervention
• one can not make express consent clearly
• dyslexia
• who need physical assistance during ambulation
• nonfunctional ambulator

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

National Defense of Medical Center, Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2 groups of participant, one of the group took the questionnaire then received the intervention for seven days, then took the same questionnaire again. The other group took the physical examination and received the intervention immediately, then took the physical examination again when the intervention is on the treating area.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: July 19, 2019
• Study Start: March 12, 2018
• Primary Completion: May 20, 2019
• Study Completion: June 20, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)