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Trial registered on ANZCTR


Registration number
ACTRN12614001278628
Ethics application status
Approved
Date submitted
14/11/2014
Date registered
5/12/2014
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic role of motor imagery at six month following total knee arthroplasty
Scientific title
Does motor imagery rehabilitation (compared to classical rehabilitation) enhance quadriceps strength, gait performance and daily activities in patients aged from 65 to 75 who underwent total knee arthroplasty?
Secondary ID [1] 285659 0
None
Universal Trial Number (UTN)
U1111-1164-0700
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroplasty 293507 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293784 293784 0 0
Physiotherapy
Musculoskeletal 293932 293932 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 with the same physiotherapist. They will receive 12 individual sessions of physiotherapy of 1 hour each, scheduled 3 times per week. Treatment will begin 6 months 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 (kinesthetic and visual imagery). 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 physiotherapist of world news not related to their illness.
the 45 minutes of classical physiotherapy included: quadriceps strengthening exercises, proprioceptive exercises and gait training exercises (maximum knee flexion during swing phase).
Motor imagery is defined as the mental representation of an action without any concomitant movement.
During each motor imagery session, we used visual imagery that requires self-visualization of a movement from a first- (internal visual imagery) or third-person (external visual imagery) perspective and kinesthetic imagery that requires to feel movement and to perceive muscle contractions mentally.Participants performed 2 blocks of each set with a 10-s rest period between rehearsals and 2-min rest period between blocks.
The physiotherapist checked whether the participants did not contract their muscles or move their knees during motor imagery exercises.
All exercises should be showed firstly by the experimenter and secondly the participants should do one trial with the contra lateral limb before starting with the operated limb.
During motor imagery training, the physiotherapist read the same imagery script specific for each exercise to ensure that the participants received similar motor imagery instructions.

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] 290601 0
Rehabilitation
Intervention code [2] 290708 0
Treatment: Other
Comparator / control treatment
Classical physiotherapy protocol includes modalities to enhance quadriceps strength and to improve functional impairments especially walking:
- active resisted exercises for quadriceps muscle
- proprioceptive exercises
- gait training (maximum knee flexion during swing phase)
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 (kinesthetic and visual imagery). 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 physiotherapist of world news not related to their illness.
Control group
Active

Outcomes
Primary outcome [1] 293583 0
maximum knee flexion during swing phase assessed using electric goniometer
Timepoint [1] 293583 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
Secondary outcome [1] 311402 0
quadriceps strength assessed using a hand held dynamometer
Timepoint [1] 311402 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
Secondary outcome [2] 311631 0
"timed up ang go" assessed using a chronometer
Timepoint [2] 311631 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
Secondary outcome [3] 311632 0
"stairs climbing test" assessed using a chronometer
Timepoint [3] 311632 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
Secondary outcome [4] 311633 0
"six minutes walk test" assessed using a meter
Timepoint [4] 311633 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session
Secondary outcome [5] 311634 0
"oxford knee score" assessed using oxford knee score questionnaire
Timepoint [5] 311634 0
pre-test: at the beginning of the program (6 months after surgery) before the first physiotherapy session
post-test: 4 weeks later after the 12th physiotherapy session

Eligibility
Key inclusion criteria
primary unilateral tricompartmental total knee arthroplasty
cause: arthritis
Minimum age
65 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- neurological disorders
- other lower extremity orthopedic problems causing function limitation
- symptomatic osteoarthritis of the contralateral knee
- diabetes
- body mass index> 35kg/m2
- neoplasms
- non cooperative patients

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation methods such as Minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
20 participants
ANOVA one-way
This is a pilot study that may help us test the existence of a significant statistical effect without a clear assumption on its size and power. Thus, it would help us later on to determine the exact sample size needed in order to have a good statistical power. Regarding the actual difficulties encountered in our clinic to recruit participants, we assume that 10 participants per group is a good beginning for such a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/11/2014
Actual
11/11/2014
Date of last participant enrolment
Anticipated
Actual
17/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 6475 0
Lebanon
State/province [1] 6475 0

Funding & Sponsors
Funding source category [1] 290246 0
Self funded/Unfunded
Name [1] 290246 0
marcel moukarzel
Country [1] 290246 0
Lebanon
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] 288952 0
University
Name [1] 288952 0
Holy Spirit University Kaslik (USEK)
Address [1] 288952 0
Jounieh BP 446, 99205 Liban

Country [1] 288952 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291948 0
Lyon1 University ethic committee.
Ethics committee address [1] 291948 0
Ethics committee country [1] 291948 0
France
Date submitted for ethics approval [1] 291948 0
03/03/2014
Approval date [1] 291948 0
21/04/2014
Ethics approval number [1] 291948 0
N/A

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

Contacts
Principal investigator
Name 52762 0
Mr Marcel Moukarzel
Address 52762 0
Marcel Moukarzel Physiotherapy Center, Antelias, Antonine Building, Bloc B, 2nd floor, Elmetn, Lebanon
Country 52762 0
Lebanon
Phone 52762 0
+961 3 782445
Fax 52762 0
+961 4 414275
Email 52762 0
physiomoukarzel@hotmail.com
Contact person for public queries
Name 52763 0
Nady Hoyek
Address 52763 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 52763 0
France
Phone 52763 0
+33 (0)4 72 43 16 25
Fax 52763 0
+33 (0)4 72 44 80 10
Email 52763 0
nady.hoyek@univ-lyon1.fr
Contact person for scientific queries
Name 52764 0
Nady Hoyek
Address 52764 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 52764 0
France
Phone 52764 0
+33 (0)4 72 43 16 25
Fax 52764 0
+33 (0)4 72 44 80 10
Email 52764 0
nady.hoyek@univ-lyon1.fr

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
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