- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04637841
Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul Medeniyet University
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İstanbul, Turkey
- İstanbul Medeniyet City
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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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.
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of foot plantar pressure distribution
Time Frame: Change from baseline plantar presure distrubution at following kinesiologic tape appliying and at 30min.
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Plantar pressure distrubution (gr/ cm²) on the force platform will be measured.
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Change from baseline plantar presure distrubution at following kinesiologic tape appliying and at 30min.
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Evaluation of stiffness
Time Frame: Change from baseline stiffness of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Stiffness (N/m) of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Change from baseline stiffness of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Evaluation of decrement
Time Frame: Change from baseline decrement properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Decrement of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Change from baseline decrement properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Evaluation of creep
Time Frame: Change from baseline creep properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Creep of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Change from baseline creep properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Evaluation of relaxation time
Time Frame: Change from baseline relaxation time properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Relaxation time of the plantar fascia will be mesured using a digital handheld myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Change from baseline relaxation time properties of the plantar fascia at following kinesiologic tape appliying and at 30min.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of range of motion of ankle
Time Frame: Change from baseline range of motion at following kinesiologic tape appliying and at 30min.
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Range of motion of ankle was measured with goniometer
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Change from baseline range of motion at following kinesiologic tape appliying and at 30min.
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Evaluation of foot sole pain
Time Frame: Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.
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Pain was evaluated by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain).
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Change from baseline foot sole pain at following kinesiologic tape appliying and at 30min.
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Evaluation of skin temperature
Time Frame: Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.
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Plantar skin temperature will be measured by thermal imaging machine (Flir Sistem, ThermaCAM, Sweden)
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Change from baseline foot sole temperature at following kinesiologic tape appliying and at 30min.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
- Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
- American Diabetes Association. 16. Diabetes Advocacy: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S182-S183. doi: 10.2337/dc19-S016.
- Bernard V, Staffa E, Mornstein V, Bourek A. Infrared camera assessment of skin surface temperature--effect of emissivity. Phys Med. 2013 Nov;29(6):583-91. doi: 10.1016/j.ejmp.2012.09.003. Epub 2012 Oct 18.
- Chen TL, Wong DW, Peng Y, Zhang M. Prediction on the plantar fascia strain offload upon Fascia taping and Low-Dye taping during running. J Orthop Translat. 2019 Aug 7;20:113-121. doi: 10.1016/j.jot.2019.06.006. eCollection 2020 Jan.
- Kong PW, Chua YH, Kawabata M, Burns SF, Cai C. Effect of Post-Exercise Massage on Passive Muscle Stiffness Measured Using Myotonometry - A Double-Blind Study. J Sports Sci Med. 2018 Nov 20;17(4):599-606. eCollection 2018 Dec.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2020.948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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