NCT02747901

Brief Summary

The investigators aim was to compare the effectiveness of kinesiotaping and cold therapy on muscle strength and functional performance outcomes in patients with TKA during early postoperative period. One-hundred-eleven patents with TKA are going to randomly assigned to control, KT and CT groups (nC=nKT=nCT=37).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

March 27, 2016

Last Update Submit

April 19, 2016

Conditions

Surgery

Keywords

KINESIOTAPINGCOLD THERAPYFUNCTIONAL PERFORMANCE

Outcome Measures

Primary Outcomes (1)

  • The maximum isometric muscle strength of Quadriceps and hamstring muscles of all the patients will be measured using Hand Held Dynamometer (Lafayette Instrument Company, Lafayette, Ind., USA).

    Before the measurement, the subjects seat with the hips on the edge of the bed, knees at ninety degree of flexion, feet free and arms crossed on the chest, without a support. The subjects complete maximum knee extension during the test. When the knee extension was achieved, the participant will be asked to continue maximum isometric contraction for five seconds. Then the mean value of three consecutive maximum contraction measurements will be taken. For the maximum isometric muscle strength of hamstring muscles of all the patients will be measured using Hand Held Dynamometer. Before the measurement, subjects lay prone on the bed, knees at ninety degree of flexion. Same measurement techniques will be used.

    Post-operative three months

Secondary Outcomes (2)

  • Pain intensity of the knees will be measured by a numerical rating scale.

    Post-operative three months

  • The active knee range of motion will be measured using a full circle manual goniometer.

    Post-operative three months

Study Arms (3)

Kinesiotaping Group

EXPERIMENTAL

Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.

Other: KINESIOTAPING

Cold Therapy Group

ACTIVE COMPARATOR

Cold Therapy group received cold pack immediately after operation and following postoperative days.

Other: COLD THERAPY

Control Group

NO INTERVENTION

Control group have no intervention.

Interventions

KINESIOTAPINGOTHER

Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.

Kinesiotaping Group
COLD THERAPYOTHER

Cold therapy group received cold packs immediately after operation and following postoperative days

Cold Therapy Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years older above
  • have a primary total knee arthroplasty

You may not qualify if:

  • revision total knee arthroplasty
  • unable to understand verbal and written instructions
  • having previously orthopaedic or neurological disorder that causes gait disturbance and having surgery within six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

İ̇zmi̇r, 35340, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.

    PMID: 24819349RESULT

  • Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.

    PMID: 22972114RESULT

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Vasfi Karatosun, Prof

    Dokuz Eylul University

    STUDY DIRECTOR

Central Study Contacts

Bayram Unver, Prof.

CONTACT

+902324123928bayram.unver@deu.edu.tr

Ertugrul YUKSEL, MSc, PT.

CONTACT

+02324123949er-tugrl@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 22, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

April 1, 2017

Last Updated

April 22, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) are going to be kept.

Locations

TU(1)