NCT03684148

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 21, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 21, 2018

Last Update Submit

September 18, 2019

Conditions

Keywords

osteoarthritismuscle voluntary activationknee replacementcognitive trainingfunctional performancerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in maximal voluntary isometric contraction of quadriceps muscle following a total knee arthroplasty

    Maximal strength assessed by isometric dynamometer

    At baseline (1 day before surgery) and one month postoperatively

Secondary Outcomes (11)

  • Change in quadriceps muscle voluntary activation following a total knee arthroplasty

    At baseline (1 day before surgery) and one month postoperatively

  • Change in range of motion of knee joint following a total knee arthroplasty

    At baseline (1 day before surgery) and one month postoperatively

  • Change in agility following a total knee arthroplasty

    At baseline (1 day before surgery) and one month and one year postoperatively

  • Change in repetitive strength of knee extensor muscles following a total knee arthroplasty

    At baseline (1 day before surgery) and one month postoperatively and one year postoperatively

  • Change in spatio temporal gait parameters following a total knee arthroplasty

    At baseline (1 day before surgery) and one month postoperatively

  • +6 more secondary outcomes

Study Arms (2)

Motor imagery practice

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients from the control group will underwent the same post-surgery rehabilitation program, but will not be engaged in MI practice.

Interventions

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.

Also known as: Routine physical therapy
Motor imagery practice

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Hospital Valdoltra

Ankaran, 6280, Slovenia

Location

Related Publications (2)

  • Paravlic AH, Pisot R, Marusic U. Specific and general adaptations following motor imagery practice focused on muscle strength in total knee arthroplasty rehabilitation: A randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0221089. doi: 10.1371/journal.pone.0221089. eCollection 2019.

  • Paravlic AH, Maffulli N, Kovac S, Pisot R. Home-based motor imagery intervention improves functional performance following total knee arthroplasty in the short term: a randomized controlled trial. J Orthop Surg Res. 2020 Oct 2;15(1):451. doi: 10.1186/s13018-020-01964-4.

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rado Pisot, PhD

    Science and Research Centre Koper

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

August 21, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

We are willing to share supplementary material such as study protocol, measurement assessment protocol, motor imagery script used in intervention etc.

Locations