- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05741996
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis? A Randomized Clinical Trial
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee Osteoartritis(OA) on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren & Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
Study Overview
Detailed Description
Objective: The aim of this study was to compare the effects of elastic taping, rigid taping, and braces applied to women with mild knee OA on pain, gait, and knee functionality.
Methods: This randomised study included 21 female patients (mean age of 53.81±6.20 years) with bilateral grade 2 knee OA according to the Kellgren & Lawrence Classification. Pain was evaluated with the visual analog scale, functionality was evaluated with the Western Ontario McMaster Osteoarthritis Index, and the kinetic, kinematic, and spatiotemporal parameters were evaluated using a three-dimensional gait analysis system at baseline (no application) and immediately after the application of elastic taping, rigid taping, and orthoses. The dependent variables were measured after 45 minute the application of four different conditions neutral, elastic taping, rigid taping, and knee brace on each participant with 1-day intervals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06018
- Tezel Yıldırım Şahan
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Ankara, Turkey, 06018
- University of Health Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- bilateral knee OA according to the criteria of the American College of Rheumatology
had radiographically phase 2 based on the criteria identified by Kellgren & Lawrence
-, had active knee pain
- did not receive any knee treatment in the last year
- could understand test and evaluations
Exclusion Criteria:
- experienced lower extremity trauma or underwent surgery
- had phase 3-4 Osteoarthritis
- had any orthopedic or neurologic problem affecting walking
- were allergic to taping
- did not walk independently on their own
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Effetcs of Taping type and Orthosis on Pain,
The order of the elastic taping, rigid taping, and braces was randomized using a computer-generated random sequence created before the research (Random.org).
Both knees of each participant were taped and braced.
The participants were allowed to become accustomed to the applied elastic taping, rigid taping, and braces before the gait analysis and evaluations.
All the taping techniques and braces were similar for all the participants.
The participants performed four evaluation condition trials at baseline and with the elastic taping, rigid taping, and braces after 45 minutes.
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Taping types and brace acute effects for knee osteoartritis
Other Names:
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Experimental: Effetcs of Taping type and Orthosis on Gait and functionality
The Western Ontario and McMaster Universities Turkish Version 3.1 (WOMAC) index is a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis. Gait analysis was conducted using a 3-dimensional VICON gait analysis system (Workstation Version 4.0, Oxford, UK). Each participant was assessed four times before and after the applications. |
Taping types and brace acute effects for knee osteoartritis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pain Maasurements
Time Frame: 5 minute
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effects of them on pain
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5 minute
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Measurements, Functionality Measurement
Time Frame: 10 minute
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effects of them on gait and functionality
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10 minute
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tezel Y Şahan, pHD, University of Health Science
Publications and helpful links
General Publications
- Anvar N, Matlabi H, Safaiyan A, Allahverdipour H, Kolahi S. Effectiveness of self-management program on arthritis symptoms among older women: A randomized controlled trial study. Health Care Women Int. 2018 Dec;39(12):1326-1339. doi: 10.1080/07399332.2018.1438438. Epub 2018 Mar 5.
- DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol, Avon). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.
- Teo PL, Hinman RS, Egerton T, Dziedzic KS, Bennell KL. Identifying and Prioritizing Clinical Guideline Recommendations Most Relevant to Physical Therapy Practice for Hip and/or Knee Osteoarthritis. J Orthop Sports Phys Ther. 2019 Jul;49(7):501-512. doi: 10.2519/jospt.2019.8676.
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
- 2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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