NCT05741996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

5 days

First QC Date

February 2, 2023

Last Update Submit

October 12, 2023

Conditions

Keywords

knee osteoarthritisathletic tapebracekinesiotapegait

Outcome Measures

Primary Outcomes (1)

  • Pain Maasurements

    effects of them on pain

    5 minute

Secondary Outcomes (1)

  • Gait Measurements, Functionality Measurement

    10 minute

Study Arms (2)

Effetcs of Taping type and Orthosis on Pain,

EXPERIMENTAL

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.

Behavioral: Taping

Effetcs of Taping type and Orthosis on Gait and functionality

EXPERIMENTAL

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.

Behavioral: Taping

Interventions

TapingBEHAVIORAL

Taping types and brace acute effects for knee osteoartritis

Also known as: Brace
Effetcs of Taping type and Orthosis on Gait and functionalityEffetcs of Taping type and Orthosis on Pain,

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tezel Yıldırım Şahan

Ankara, 06018, Turkey (Türkiye)

Location

University of Health Science

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (3)

  • 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). 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Braces

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Tezel Y Şahan, pHD

    University of Health science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 23, 2023

Study Start

January 5, 2023

Primary Completion

January 10, 2023

Study Completion

January 20, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

If they want from corresponding author then can be shaberable.

Locations