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

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT04637841
Collaborator
(none)
26
2
4
3.8
13
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesiology Taping Appliying
  • Other: Myofascial Release Technique Appliying
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
May 3, 2021
Actual Study Completion Date :
May 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diabetes Mellitus Kinesiology Taping Group

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

Other: Kinesiology Taping Appliying
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.

Active Comparator: Kinesiology Taping Control Group

Kinesiology tape will be applied to the left foot of the healthy participants in the control group.

Other: Kinesiology Taping Appliying
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.

Active Comparator: Diabetes Mellitus Myofascial Release Group

Myofascial Release Technique will be applied to the right foot of the participants in diabetes mellitus group.

Other: Myofascial Release Technique Appliying
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.

Active Comparator: Myofascial Release Control Group

Myofascial Release Technique taping will be applied to the right foot of the healthy participants in the control group.

Other: Myofascial Release Technique Appliying
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of foot plantar pressure distribution [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 [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 [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 [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 [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 Outcome Measures

  1. Evaluation of range of motion of ankle [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Medeniyet City İstanbul Turkey
2 İstanbul Medeniyet University Istanbul Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT04637841
Other Study ID Numbers:
  • 09.2020.948
First Posted:
Nov 20, 2020
Last Update Posted:
Jan 20, 2022
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022