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Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Taping
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring knee osteoarthritis, athletic tape, brace, kinesiotape, gait

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tezel Yıldırım Şahan
  • University of Health Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Effetcs of Taping type and Orthosis on Pain,

Effetcs of Taping type and Orthosis on Gait and functionality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Maasurements
effects of them on pain

Secondary Outcome Measures

Gait Measurements, Functionality Measurement
effects of them on gait and functionality

Full Information

First Posted
February 2, 2023
Last Updated
October 12, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05741996
Brief Title
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?
Official Title
Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee osteoarthritis, athletic tape, brace, kinesiotape, gait

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effetcs of Taping type and Orthosis on Pain,
Arm Type
Experimental
Arm Description
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.
Arm Title
Effetcs of Taping type and Orthosis on Gait and functionality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Taping
Other Intervention Name(s)
Brace
Intervention Description
Taping types and brace acute effects for knee osteoartritis
Primary Outcome Measure Information:
Title
Pain Maasurements
Description
effects of them on pain
Time Frame
5 minute
Secondary Outcome Measure Information:
Title
Gait Measurements, Functionality Measurement
Description
effects of them on gait and functionality
Time Frame
10 minute

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tezel Y Şahan, pHD
Organizational Affiliation
University of Health science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tezel Yıldırım Şahan
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
Facility Name
University of Health Science
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If they want from corresponding author then can be shaberable.
Citations:
PubMed Identifier
29419362
Citation
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.
Results Reference
result
PubMed Identifier
30273922
Citation
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.
Results Reference
result
PubMed Identifier
31258044
Citation
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.
Results Reference
result

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Do Taping and Orthosis Affect Pain, Gait, or Functionality in Mild Knee Osteoarthritis?

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