Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Motor Imagery Intervention on Functional Recovery Following Total Knee Arthroplasty (KSV2017)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03684148
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Science and Research Centre Koper

Brief Summary:
The knee osteoarthritis becoming a leading cause of disability among older adults' population. When conventional treatments fail, a total knee arthroplasty (TKA) is suggested. Although TKA treatment significantly reduces pain and improve mobility of patients, there is still high prevalence of patients whose neuromuscular function is impaired up to three years following TKA, which can be directly prescribed to poor or/and inadequate rehabilitation practice. Thus, motor imagery (MI) is proposed as additional rehabilitation tool to convention physical therapy to reduce decline of neuromuscular function in early days post-surgery. Recent studies showed that MI could facilitate learning and acquisition of motor skills, as well as maintain and retain previously acquired motor skills, which may be beneficial for those who undergo TKA. It represents an incentive in the process of motor learning and the transfer of the mental scheme of the motion pattern into the process of movement execution. Measuring neuromuscular function pre- and post-TKA could be unique opportunity to provide empirical evidence about its additional therapeutic effects. Outcomes of proposed research project could serve to improve existing intervention programs applied in rehabilitation protocols following TKA surgery as well as other orthopedic interventions. This would also contribute to the successful return of individuals after an injury to their everyday working routine. We hypothesized that MI practice group will experience better both subjective and objective measures of functional performance compared to control group that will be subjected to routine physical therapy only.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Knee Arthroplasty Other: Motor imagery practice Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a randomized, controlled, parallel-group intervention trial to evaluate the benefits of adding MI practice to CPT postoperative rehabilitation program. Eligible patients were randomly assigned to either an intervention group in which MI practice was combined with CPT (MIp), or to a control group which received CPT alone (CON).
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Effects of Motor Imagery Intervention on Functional Recovery Following Total Knee Arthroplasty
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Motor imagery practice
In addition to routine physical therapy patients that will be included in the motor imagery practice (MIp) group will receive an additional intervention based on motor imagery beginning immediately after the TKA procedure.
Other: Motor imagery practice
In detail, they were advised to imagine maximal voluntary isometric contractions (MViC). MViC imagery practice was planned in a progressive manner. Thus, it was performed in two sets of 25 repetitions with 2 minutes of inter-sets rest period, for two weeks, and 10 additional repetitions were added on week three and four, respectively. Each MViC repetition was sustained for 5 seconds, followed by 5 seconds of inter-repetition rest periods. Additionally, after every fifth contraction, participants had a 20 seconds of rest. Following 5 days of MI practice, the participants were advised to take a break from MI for two consecutive days. After hospital discharge, the participants in the MIp group were supplied with an audio description of the exercises to be performed.
Other Name: Routine physical therapy

No Intervention: Control group
Patients from the control group will underwent the same post-surgery rehabilitation program, but will not be engaged in MI practice.



Primary Outcome Measures :
  1. Change in maximal voluntary isometric contraction of quadriceps muscle following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively ]
    Maximal strength assessed by isometric dynamometer


Secondary Outcome Measures :
  1. Change in quadriceps muscle voluntary activation following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively ]
    Voluntary activation level was assessed by double interpolated twitch technique

  2. Change in range of motion of knee joint following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively ]
    Flexion and extension range of motion of knee joint, assessed by manual long-arm goniometer

  3. Change in agility following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month and one year postoperatively ]
    Agility and dynamic balance will be assessed by timed up to go test

  4. Change in repetitive strength of knee extensor muscles following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively and one year postoperatively ]
    Repetitive strength of knee extensor muscles will be assessed by chair sit to stand test

  5. Change in spatio temporal gait parameters following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively ]
    Spatio-temporal gait parameters (STGP) during different gait velocities will be measured by OPTOGAIT system (Microgate, Bolzano, Italy) under single- and dual-task conditions

  6. Change in hand grip strength following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively and one year postoperatively ]
    Hand grip strength will be measured by hand held dynamometer

  7. Change in functional assessment scale measured by Oxford Knee Score following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively and one year postoperatively ]
    Self - reported functional assessment was measured by Oxford Knee Score (OKS) questionnaire. The OKS is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee arthroplasty (TKA) surgery. Each item can be scored from 1 to 5 points depending on patients pain and/or functional status level. Greater the score, better is function. It is short, reproducible, valid and sensitive to clinically important changes.

  8. Change in functional assessment scale measured by Lower Extremity Functional Scale following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively and one year postoperatively ]

    Self - reported functional assessment was measured by Lower Extremity Functional Scale (LEFS). That is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.

    The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The columns on the scale are summed to get a total score. The maximum score is 80. The greater the score, function is better.


  9. Change in contractile muscle parameters following a total knee arthroplasty [ Time Frame: Participants will be assessed 1 day before surgery and one month postoperatively ]

    Contractile muscle parameters will be assessed by Tensiomiography (TMG). TMG will be used to detect muscle belly enlargement in transversal plane during an isometric twitch contraction with a means of digital high-precision displacement sensor. From TMG following parameters will be derived:

    Time of contraction (Tc) Sustain time (Ts) Relaxation time (Tr) Delay time (Td) and Displacement of muscle belly (Dm)


  10. Change in electromechanical efficiency index following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively ]
    Electromechanical efficiency index will be assessed by Tensiomyography and M-wave module

  11. Change in self perceived pain level following a total knee arthroplasty [ Time Frame: At baseline (1 day before surgery) and one month postoperatively and one year postoperatively ]
    Self perceived pain level will be assessed by Visual Analog Scale (VAS). The VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points from 1 to 100. Greater the score, greater the level of self perceived level of pain of patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for unilateral TKA secondary to osteoarthritis;
  • age from 50 to 80 years old;
  • participants were not engaged in preoperative treatments

Exclusion Criteria:

  • participants who were undergoing a revision TKA;
  • body mass index (BMI) greater than 40 kg/m2;
  • participants who were receiving a bilateral TKA's;
  • uncontrolled hypertension;
  • diabetes mellitus;
  • a history of any neurological disorder;
  • multiple sclerosis;
  • Parkinson's disease;
  • patients with rheumatoid arthritis or active cancer;
  • previous history of deep vein thrombosis;
  • contralateral knee OA (as defined by pain greater than 4/10 with activity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684148


Locations
Layout table for location information
Slovenia
Orthopaedic Hospital Valdoltra
Ankaran, Slovenia, 6280
Sponsors and Collaborators
Science and Research Centre Koper
Slovenian Research Agency
Investigators
Layout table for investigator information
Study Director: Rado Pisot, PhD Science and Research Centre Koper

Layout table for additonal information
Responsible Party: Science and Research Centre Koper
ClinicalTrials.gov Identifier: NCT03684148     History of Changes
Other Study ID Numbers: Knee Study Valdoltra 2017
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are willing to share supplementary material such as study protocol, measurement assessment protocol, motor imagery script used in intervention etc.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Science and Research Centre Koper:
osteoarthritis
muscle voluntary activation
knee replacement
cognitive training
functional performance
randomized controlled trial

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases