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NCT Number: NCT04637841

Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping

As a result of glycation of collagen fibers in diabetes mellitus, an increase in thickness and stiffness is observed in the plantar fascia, which is a connective tissue. These changes in the plantar fascia affect the windlass mechanism of the foot, normal range of motion and foot plantar pressure distribution. These biomechanical effects may cause the development of diabetic foot ulcers in the later stages of the disease. We hypothesis that myofascial release technique and kinesiology taping methods have an effect on plantar fascia stiffness and plantar pressure distribution in diabetic patients. The aim of this study is to investigate the immediate effects of the two methods on the stiffness of the plantar fascia and foot sole pressure distribution in diabetic patients.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Plantar Fascia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Medeniyet City, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those with diabetic foot ulcer development risk groups 1 and 2 according to the International Working Group on the Diabetic Foot (IWGDF)
  • Those who have diabetes for at least 5 years
  • Ambulation independently without using an assistive device

Exclusion criteria

  • Those with foot posture deformity
  • Having another disease that will affect connective tissue properties
  • Presence of orthopedic or neurological disorders that will affect plantar load distribution
  • History of surgery and fractures from the ankle-foot in the last 6 months

Treatment and study plan

Kinesiology Taping Appliying

Other

Kinesiology tape will be applied to left foot plantar fascia of the participants in diabetes mellitus and control group.

During taping, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position. A "Palm Shape" taping procedure will be applied to the plantar fascia.

Myofascial Release Technique Appliying

Other

Myofascial release technique will be applied (during 5 minutes) to right foot plantar fascia of the participants in diabetes mellitus and control group

During appliying technique, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position.

Primary outcomes

  1. Evaluation of foot plantar pressure distribution

    Time frame: Change from baseline plantar presure distrubution at following kinesiologic tape appliying and at 30min.

    Plantar pressure distrubution (gr/ cm²) on the force platform will be measured.

  2. Evaluation of stiffness

    Time frame: Change from baseline stiffness of the plantar fascia at following kinesiologic tape appliying and at 30min.

    Stiffness (N/m) of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).

  3. Evaluation of decrement

    Time frame: Change from baseline decrement properties of the plantar fascia at following kinesiologic tape appliying and at 30min.

    Decrement of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).

  4. Evaluation of creep

    Time frame: Change from baseline creep properties of the plantar fascia at following kinesiologic tape appliying and at 30min.

    Creep of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).

  5. Evaluation of relaxation time

    Time frame: Change from baseline relaxation time properties of the plantar fascia at following kinesiologic tape appliying and at 30min.

    Relaxation time of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).

Secondary outcomes

  1. Evaluation of range of motion of ankle

    Time frame: Change from baseline range of motion at following kinesiologic tape appliying and at 30min.

    Range of motion of ankle was measured with goniometer

  2. Evaluation of foot sole pain

    Time frame: Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.

    Pain was evaluated by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain).

  3. Evaluation of skin temperature

    Time frame: Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.

    Plantar skin temperature will be measured by thermal imaging machine (Flir Sistem, ThermaCAM, Sweden)

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping on Biomechanical and Viscoelastic Properties of Plantar Fascia and Plantar Pressure Distribution in Diabetes Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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