NCT05138406

Brief Summary

This study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis.

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
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

October 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 28, 2021

Last Update Submit

November 10, 2022

Conditions

Keywords

Graded Motor ImageryPainRehabilitationTotal knee arthroplasty

Outcome Measures

Primary Outcomes (6)

  • Pain intensity

    Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS). The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".

    Baseline

  • Pain intensity

    Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS). The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".

    6 weeks after surgery

  • Pain intensity

    Pain at rest and during activity will be evaluated with the help of the Visual Analogue Scale (VAS). The VAS is a 10 cm scale that rates 0 points as "no pain" and 10 points as "worst pain imaginable".

    6 months after surgery

  • WOMAC

    Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items. Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    Baseline

  • WOMAC

    Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items. Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    6 weeks after surgery

  • WOMAC

    Functional status will be assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It consists of three subgroups as pain (5 items), stiffness (2 items) and physical function (17 items) and a total of 24 items. Each item has an evaluation score of 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    6 months after surgery

Secondary Outcomes (30)

  • Pressure pain threshold

    Baseline

  • Pressure pain threshold

    6 weeks after surgery

  • Pressure pain threshold

    6 months after surgery

  • Central sensitization

    Baseline

  • Central sensitization

    6 weeks after surgery

  • +25 more secondary outcomes

Study Arms (2)

Graded Motor Imagery

EXPERIMENTAL

Individuals will receive standard rehabilitation and graded motor imagery treatment.

Other: Graded Motor ImageryOther: Standard Rehabilitation

Standard Rehabilitation Group

ACTIVE COMPARATOR

Standard rehabilitation will be applied.

Other: Standard Rehabilitation

Interventions

The graded motor imaging program will be set to 2 weeks each component. Participants will receive lateralization for the first 2 weeks, motor imagery for 2 weeks, and mirror therapy for 2 weeks. At the same time, standard rehabilitation will be applied for 6 weeks. Treatments will begin 24-48 hours after surgery. Treatments will be applied under the control of a physiotherapist 3 days a week and as home exercise 3 days a week.

Graded Motor Imagery

Standard rehabilitation consisting of cold therapy, stretching and strengthening exercises will be applied. Treatment will be applied under the control of a physiotherapist 3 days a week and as home exercise 3 days a week.

Graded Motor ImageryStandard Rehabilitation Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with knee osteoarthritis and being on the waiting list to receive unilateral total knee arthroplasty
  • Approved by the orthopedist for early physiotherapy treatment after total knee arthroplasty

You may not qualify if:

  • \- Individuals undergoing revision total knee arthroplasty or undergoing bilateral total knee arthroplasty,
  • Contralateral knee osteoarthritis (defined by activity greater than 4/10 pain)
  • Having undergone any physical therapy intervention or other surgery in the last 6 months
  • Any neurological, cardiac, pulmonary or psychiatric disease (eg, uncontrolled diabetes mellitus, neoplasms, uncontrolled blood pressure, neurological conditions) before or after surgery;
  • Fracture, infection in the acute postoperative phase or presence of fever
  • Cognitive impairments that alter the probability of correct understanding of the motor imagery program
  • Body mass index \> 35 kg / m2
  • Difficulties with understanding or communication
  • Insufficient knowledge of Turkish to follow the study instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Unıversity

Malatya, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • La Touche R, Grande-Alonso M, Cuenca-Martinez F, Gonzalez-Ferrero L, Suso-Marti L, Paris-Alemany A. Diminished Kinesthetic and Visual Motor Imagery Ability in Adults With Chronic Low Back Pain. PM R. 2019 Mar;11(3):227-235. doi: 10.1016/j.pmrj.2018.05.025. Epub 2019 Jan 15.

    PMID: 29908933BACKGROUND
  • Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan-Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.

    PMID: 29122370BACKGROUND
  • Gurudut P, Jaiswal R. Comparative Effect of Graded Motor Imagery and Progressive Muscle Relaxation on Mobility and Function in Patients with Knee Osteoarthritis: A Pilot Study. Altern Ther Health Med. 2022 Mar;28(3):42-47.

    PMID: 33128533BACKGROUND
  • Lee HG, An J, Lee BH. The Effect of Progressive Dynamic Balance Training on Physical Function, The Ability to Balance and Quality of Life Among Elderly Women Who Underwent a Total Knee Arthroplasty: A Double-Blind Randomized Control Trial. Int J Environ Res Public Health. 2021 Mar 3;18(5):2513. doi: 10.3390/ijerph18052513.

    PMID: 33802559BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Burcu TALU

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 28, 2021

First Posted

December 1, 2021

Study Start

February 28, 2022

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations