Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000397718
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
11/04/2013
Date last updated
11/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of motor imagery in the rehabilitation of total knee replacement
Scientific title
Does motor imagery rehabilitation (compared to classical rehabilitation) reduce pain, enhance mobility and muscle strengthening and gait performance in patients who underwent total knee replacement
Secondary ID [1] 282241 0
None
Universal Trial Number (UTN)
U1111-1140-7968
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 288760 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289117 289117 0 0
Physiotherapy
Musculoskeletal 289118 289118 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo the same physiotherapy treatment. They will receive 15 individual sessions of physiotherapy of 1 hour each, scheduled 3 times per week. Treatment will begin 1 week post-operatively.
In the experimental group, we will add “motor imagery” exercises into classical physiotherapy session during the last 15 minutes of the session. Practically they will practice a sequence of motor imagery exercises (relaxing, concentric and eccentric exercises). The control group will be subjected to a period of neutral activities during equivalent time. Accordingly they will spend the last 15 minutes of the session to discuss with the experimenter of world news not related to their illness.
An informed consent including the description and the schedule of the rehabilitation program will be signed by all participants. Furthermore all participants will provide a signature at the end of every session.
Intervention code [1] 286852 0
Rehabilitation
Intervention code [2] 286853 0
Treatment: Other
Comparator / control treatment
Conventional physiotherapy consists on the sequences of the following techniques:
- Passive mobilization of the patella to relieve stiffness
- Massage of the thigh to relieve muscle spasm
- Active mobilization of the knee to relieve stiffness
- Passive mobilization of the knee, using a continuous passive motion machine to increase range of motion
- Isometric, active and active resisted exercises to increase muscle strength
- Gait training
- Proprioceptive exercises
- Up and down stairs exercises
- Cryotherapy to relieve pain and decrease swelling
Control group
Active

Outcomes
Primary outcome [1] 289229 0
Primary outcome: pain: assessed using a Horizontal Visual Analog Scale (H-VAS)
Timepoint [1] 289229 0
pre-test: at the beginning of the program before the first physiotherapy session
Post-test: 5 weeks later after the 15th physiotherapy session
Primary outcome [2] 289230 0
knee range of motion: assessed using a goniometer and a digital inclinometer
Timepoint [2] 289230 0
pre-test: at the beginning of the program before the first physiotherapy session
Post-test: 5 weeks later after the 15th physiotherapy session
Primary outcome [3] 289231 0
quadriceps and hamstrings strength: assessed using a hand-held dynamometer
Timepoint [3] 289231 0
pre-test: at the beginning of the program before the first physiotherapy session
Post-test: 5 weeks later after the 15th physiotherapy session
Secondary outcome [1] 302076 0
None
Timepoint [1] 302076 0
None

Eligibility
Key inclusion criteria
unilateral total knee replacement
Kinesthetic and Visual Imagery Questionnaire (KVIC): 2 standard deviations above or below the mean
Body Mass Index (BMI)<40
cause: arthritis
Minimum age
56 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with neurological disorders such as parkinson, multiple sclerosis.
patients with psychological disorders.
patients with post-op complications such as infection, embolism.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation: Minimisation method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4970 0
Lebanon
State/province [1] 4970 0
Beirut
Country [2] 4971 0
France
State/province [2] 4971 0
Lyon

Funding & Sponsors
Funding source category [1] 287005 0
Self funded/Unfunded
Name [1] 287005 0
N/A
Country [1] 287005 0
Primary sponsor type
University
Name
CRIS-Lyon1 University
Address
27-29 Boulevard du 11 Novembre 1918
69 622 Villeurbanne Cedex, France
Country
France
Secondary sponsor category [1] 285790 0
Hospital
Name [1] 285790 0
Rafik Hariri University Hospital
Address [1] 285790 0
Bir-Hasan, Jinah-Beirut-Lebanon
Country [1] 285790 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289048 0
Lyon1 University ethic committee
Ethics committee address [1] 289048 0
Ethics committee country [1] 289048 0
France
Date submitted for ethics approval [1] 289048 0
01/02/2013
Approval date [1] 289048 0
02/04/2013
Ethics approval number [1] 289048 0
N/A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38974 0
Mr Marcel Moukarzel
Address 38974 0
Marcel Moukarzel Physiotherapy Center, Antelias, Antonine Building, Bloc B, 2nd floor, Metn, Lebanon
Country 38974 0
Lebanon
Phone 38974 0
+961 3 782445
Fax 38974 0
+961 4 414275
Email 38974 0
[email protected]
Contact person for public queries
Name 38975 0
Nady Hoyek
Address 38975 0
Centre de Recherche et d'Innovation sur le Sport-CRIS Laboratoirede la Performance Motrice, Mentale et du Materiel (P3M) Universite Claude Bernard-Lyon1-UFR STAPS 27-29 Boulevard du 11 Novembre 1918 69 622 Villeurbanne Cedex, France
Country 38975 0
France
Phone 38975 0
+33 (0)4 72 43 16 25
Fax 38975 0
+33 (0)4 72 44 80 10
Email 38975 0
[email protected]
Contact person for scientific queries
Name 38976 0
Nady Hoyek
Address 38976 0
Centre de Recherche et d'Innovation sur le Sport-CRIS Laboratoirede la Performance Motrice, Mentale et du Materiel (P3M) Universite Claude Bernard-Lyon1-UFR STAPS 27-29 Boulevard du 11 Novembre 1918 69 622 Villeurbanne Cedex, France
Country 38976 0
France
Phone 38976 0
+33 (0)4 72 43 16 25
Fax 38976 0
+33 (0)4 72 44 80 10
Email 38976 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.