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Trial registered on ANZCTR


Registration number
ACTRN12617000630314
Ethics application status
Approved
Date submitted
21/03/2017
Date registered
1/05/2017
Date last updated
10/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of motor imagery after total knee arthroplasty: pilot study.
Scientific title
Effectiveness of motor imagery after total knee arthroplasty on knee pain and function: pilot study
Secondary ID [1] 291491 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroplasty 302558 0
Knee osteoarthritis 302733 0
Condition category
Condition code
Musculoskeletal 302090 302090 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 302251 302251 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to demonstrate the efficacy of the motor imagery technique in combination with conventional physiotherapy versus the effectiveness of conventional physiotherapy only in patients undergoing total knee arthroplasty due to osteoarthrosis.

For this, both therapies will be compared. Patients participating in the study will be randomized into two groups:
-Group A: conventional physiotherapy.
- Group B: conventional physiotherapy implemented with motor imagery.

Therefore the only difference between the two groups will be the motor imagery, our objective to study.
The Motor Imagery is a representation of movement technique's, process during which an individual mentally simulates a movement the action without its actual execution.
The process is carried out as follows:
- Observation of movement in another person.
- Observation of movement in the non-operated lower limb.
- Imagination of the realization of movement in the non-operated lower limb.
- Imagination of movement in the operated lower limb.
- Realization of the movement.
This process has been implemented in the protocol of therapeutic exercises of habitual physiotherapy, that is, motor imagery will be ustilised for each exercise performed during sessions, always guided by the physiotherapist.
Autonomous follow-up of therapy will be recommended in both groups.

For this study we will need two physical therapists with more than 5 years of experience: physiotherapist 1 or evaluator who will be the one who will perform the data collection and physiotherapist 2 or executor of the intervention. The evaluating physiotherapist will be blinded to the intervention and the physiotherapist who executes the intervention will be blinded to the measurements.

It will be held individually in your hospital room starting the second day after surgery.
Patients in both groups will perform an individual physical therapy session a day for a total of 5 sessions of 30 minutes each session.

Before to data collection, the patient information sheet will be provided along with informed consent for signature.
Intervention code [1] 297560 0
Rehabilitation
Intervention code [2] 297683 0
Treatment: Other
Comparator / control treatment
An active control will be used; The control group will be treated as is usually done in the hospital unit, following the steps of the clinical guide for knee arthroplasties.

As in the case of intervention, the treatment will be 5 sessions daily, 30 minutes each, performed individually.
Control group
Active

Outcomes
Primary outcome [1] 301532 0
Effectiveness of motor imagery after total knee arthroplasty on knee functional capacity assessed using the WOMAC questionnaire.
Timepoint [1] 301532 0
Assessed at days 3 and 5 post-surgery.
Secondary outcome [1] 332942 0
Knee pain intensity as assessed using the Visual Analogue Scale (VAS).
Timepoint [1] 332942 0
Assessed at baseline and after 5 days of treatment.
Secondary outcome [2] 332943 0
Perception of pain threshold measured with a pressure algometer.
Timepoint [2] 332943 0
Assessed at baseline and after 5 days of treatment.
Secondary outcome [3] 332944 0
Joint amplitude variation of the knee assessed through clinical goniometric measures
Timepoint [3] 332944 0
Assessed at days 1 and 5 post-surgery.

Eligibility
Key inclusion criteria
- To undergo total knee arthroplasty due to osteoarthrosis.
- Age between 60 and 85 years.
- Signature of informed consent.
Minimum age
60 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of neurological pathology.
- Diagnosis of psychiatric or developmental disorders.
- Uncompensated and / or uncontrolled cardiac pathology.
- Severe respiratory pathology
- Acute fracture.
- Cognitive impairment.
- Infectious, febrile or uncompensated tension (hypo / hypertension).
- Alterations that prevent the understanding by the patient of the slogans of the proposed treatment.
- Any other alteration that contraindicates the intervention of the physiotherapist during the development of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size consisted of a total of 30 subjects, operated on total knee arthroplasty of the traumatology department of the Hospital 12 de Octubre, by means of consecutive sampling. In the scientific literature consulted, we have not exploited the evidence that compares the two interventions used in this study, therefore, by carrying out a previous study to know an approximation of the differences that can be found if they existed. For this reason, it is not possible to estimate the change that can be considered as significant to perform the calculation of the sample size and to be performed first in a study in order to carry out the calculation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8753 0
Spain
State/province [1] 8753 0
Madrid

Funding & Sponsors
Funding source category [1] 295970 0
University
Name [1] 295970 0
Universidad Complutense de Madrid
Address [1] 295970 0
Universidad Complutense de Madrid.
Facultad de enfermeria, fisioterapia y podologia.
Plaza de Ramon y Cajal, s/n, 28040 Madrid
Country [1] 295970 0
Spain
Primary sponsor type
University
Name
Universidad Complutense de Madrid
Address

Universidad Complutense de Madrid. Facultad de enfermeria, fisioterapia y podologia.
Plaza de Ramon y Cajal, s/n, 28040 Madrid
Country
Spain
Secondary sponsor category [1] 294863 0
None
Name [1] 294863 0
Address [1] 294863 0
Country [1] 294863 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297241 0
ethics committee of the Hospital 12 October, Madrid
Ethics committee address [1] 297241 0
Avd. de Cordoba s/n 28041, Madrid
Centro de Actividades ambulatorias, bloque D, planta 6a
Ethics committee country [1] 297241 0
Spain
Date submitted for ethics approval [1] 297241 0
01/02/2017
Approval date [1] 297241 0
14/02/2017
Ethics approval number [1] 297241 0
17/072

Summary
Brief summary
The increase in life expectancy in Spain translates into a progressive aging of the population and thus an increase in chronic degenerative joint pathologies such as knee osteoarthrosis, with arthroplasty being the treatment of choice for advanced phases in patients Who have severe pain and disability, and have not benefited from conservative therapy.

Relatively recent evidence suggests that motion-representation techniques may be effective in reducing pain, increasing joint amplitude, and improving the functionality of patients following knee arthroplasty. Motor Imagery (MI) is a technique of motion representation, a process during which an individual mentally simulates a movement or action without its execution, activating the same neural networks that are involved in the real movements, thus improving performance and training new motor skills.

In order to corroborate the effectiveness of MI, a clinical trial pilot study will be conducted with patients aged 60-85 years undergoing total knee arthroplasty. They will be divided into two groups: a first group that will be treated with conventional physiotherapy implemented with MI and a second group where only conventional physiotherapy will be used with blind evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73434 0
Miss Maria Briones Cantero
Address 73434 0
Indalecio Fernandez 5B, 2B, cp 28041 Madrid.

Hospital Universitario 12 de Octubre, Avd de Cordoba s/n cp 28041
Country 73434 0
Spain
Phone 73434 0
+34 913908000
Fax 73434 0
Email 73434 0
marbri02@ucm.es
Contact person for public queries
Name 73435 0
Miss Maria Briones
Address 73435 0
Indalecio Fernandez 5B, 2B, cp 28041 Madrid.

Hospital Universitario 12 de Octubre, Avd de Cordoba s/n cp 28041
Country 73435 0
Spain
Phone 73435 0
+34 917792072
Fax 73435 0
Email 73435 0
marbri02@ucm.es
Contact person for scientific queries
Name 73436 0
Miss Maria Briones
Address 73436 0
Indalecio Fernandez 5B, 2B, cp 28041 Madrid.

Hospital Universitario 12 de Octubre, Avd de Cordoba s/n cp 28041
Country 73436 0
Spain
Phone 73436 0
+34 635470458
Fax 73436 0
Email 73436 0
marbri02@ucm.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary