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Trial registered on ANZCTR


Registration number
ACTRN12618000753257
Ethics application status
Approved
Date submitted
25/02/2018
Date registered
4/05/2018
Date last updated
15/05/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of motor control exercises on the muscles of the iliac rim on changes in functional and structural parameters in patients with hallux valgus
Scientific title
Effect of motor control exercises on the muscles of the iliac rim on changes in functional and structural podological values in participants with hallux valgus.
Secondary ID [1] 294086 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorder of the arching of the foot. 306652 0
Hallux valgus 307444 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305753 305753 0 0
Other physical medicine / rehabilitation
Musculoskeletal 305754 305754 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
1. An interview
2. Instruction of the measurement and testing procedures
3. Signing the consent for participant
4. Podological examination of the arch of the foot and angle of hallux.
5. Electromyographic examination of pelvic rim and hip muscles strength
6. Examination of pelvic tilt usingan electronic inclinometer
7. Motor control muscles activation techniques:
A. Technique one:
Patient: side-back lying with the knees extended on the table, with one hand on the gluteus medius for feedback.
Therapist: stands behind patients back and perform activation of gluteus medius using abduction and external rotation of the patients hip without back compensation.
B. Technique two:
Patient: prone lying with the knees extended on the table, with a hand on gluteus maximus for feedback.
Therapist: stands at the level of the patient performs muscle activation using extension of the treating hip without compensation on the lumbar spine.
C. Technique three:
Patient: supine lying with knees flexed at 60 degrees with feet resting on the wall. Legs position with neutral rotation of hips. Patients hand lying on the medial head of quadriceps femoris.
Therapist: Stands at the level of the patient, performing muscle activation using hands pressure towards the treated knee to the abduction and flexion of the hip, which should activate and the medialis head of quadriceps.
D. Technique four:
Patient: Standing position back to the wall, with neutral rotation of the hips, and feet together.
Therapist: Instructs how to perform the reciprocal braking of tensor fasciale latae using active posterior rotation of the pelvis, without compensation at the rest of the body.
Patient needs to hold the position in 30 seconds.

E. Technique five:
Patient: Stand back to a table, treated leg has flexed knee, and foot based on table.
Therapist: Instructs how to perform the reciprocal braking of rectus femoris using posterior rotation of the pelvis without compensation of the rest of the body. Patient need to hold the position for 30 seconds.
7. One group receives all techniques + toe sepatarors, second group receives all techniques with instructions how to perform correct movement in exercise, but without focusing on reciprocal braking and muscle activation - just instruct how to perform movement + toe separators, using the same time of exercise as group 1.
8. Treatment for group 1 and 2 administres physiotherapist
9. Mode of administration is individual face-to-face sessions
10. Treatment sessions will take 30 minutes per day, five sessions per week for 10 weeks for group one and group two.
11. Treatment will be assessed by physiotherapist using podological examination of the arch of the foot and angle of hallux; pelvic tilt examination, and electromyographic examination of pelvic rim and hip muscles strength
12. Instructions will be given by physiotherapist to the patients.
13. Toe separators are made of gel, size: 3,5cm x 2cm x 1,2cm x 1,9cm
Intervention code [1] 300411 0
Rehabilitation
Intervention code [2] 300439 0
Treatment: Other
Comparator / control treatment
Group of patients who receives all techniques with instructions how to perform correct movement in exercise, but without focusing on reciprocal braking and muscle activation - just instruct how to perform movement + toe separators. Group 2
Control group
Active

Outcomes
Primary outcome [1] 304916 0
Influence of motor control exercises of the iliac rim to the functional and structural changes in podological values in people with hallux valgus. The outcome will be assessed using podoscope.
Timepoint [1] 304916 0
Primary timepoint is before muscle activation in the first session. Primary endpoint is after 10 weeks of motor control training.
Secondary outcome [1] 343611 0
The electromyographic examination of pelvic rim and hip muscles reciprocal breaking: tensor fasciae latae
Timepoint [1] 343611 0
Secondary timepoint is before muscle activation in the first session. Secondary endpoint is after 10 weeks of motor control training.
Secondary outcome [2] 346202 0
The electromyographic examination of pelvic rim and hip muscles reciprocal breaking: rectus femoris.
Timepoint [2] 346202 0
Secondary timepoint is before muscle activation in the first session. Secondary endpoint is after 10 weeks of motor control training.
Secondary outcome [3] 346203 0
The electromyographic examination of pelvic rim and hip muscles activation: gluteus maximus.
Timepoint [3] 346203 0
Secondary timepoint is before muscle activation in the first session. Secondary endpoint is after 10 weeks of motor control training.
Secondary outcome [4] 346204 0
The electromyographic examination of pelvic rim and hip muscles activation: gluteus medius,
Timepoint [4] 346204 0
Secondary timepoint is before muscle activation in the first session. Secondary endpoint is after 10 weeks of motor control training.
Secondary outcome [5] 346205 0
The electromyographic examination of pelvic rim and hip muscles activation: medial head of quadriceps.
Timepoint [5] 346205 0
Secondary timepoint is before muscle activation in the first session. Secondary endpoint is after 10 weeks of motor control training.

Eligibility
Key inclusion criteria
1. Written informed consent
2. Hallux valgus 2nd and 3rd grade of Manchester scale
3. Aged at least 18 years
4. Overall well-being on the day of examination
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged less than 18
2. No hallux valgus
3. Hallux valgus 4th grade of Manchester scale
4. Surgeries in the abdomen, pelvis, lower extremities in the last of 10 years
5. Injuries of the lower extermities, pelvis or spine on the examination day
6. Rheumatological diseases

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 will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a numbered envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2018
Actual
2/01/2019
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
13/05/2019
Actual
13/05/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 9622 0
Poland
State/province [1] 9622 0

Funding & Sponsors
Funding source category [1] 298715 0
University
Name [1] 298715 0
Opole Medical School
Country [1] 298715 0
Poland
Primary sponsor type
University
Name
Opole Medical School, Department of Physiotherapy
Address
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole, Poland
Country
Poland
Secondary sponsor category [1] 297889 0
None
Name [1] 297889 0
Address [1] 297889 0
Country [1] 297889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299662 0
Commission of Bioethics at Wroclaw Medical University
Ethics committee address [1] 299662 0
Ethics committee country [1] 299662 0
Poland
Date submitted for ethics approval [1] 299662 0
Approval date [1] 299662 0
13/02/2018
Ethics approval number [1] 299662 0
KB-48/2018

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

Contacts
Principal investigator
Name 81214 0
Dr Lukasz Kosowski
Address 81214 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 81214 0
Poland
Phone 81214 0
+48 668 698 234
Fax 81214 0
Email 81214 0
kosowskil@wsm.opole.pl
Contact person for public queries
Name 81215 0
Lukasz Kosowski
Address 81215 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 81215 0
Poland
Phone 81215 0
+48 668 698 234
Fax 81215 0
Email 81215 0
kosowskil@wsm.opole.pl
Contact person for scientific queries
Name 81216 0
Lukasz Kosowski
Address 81216 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 81216 0
Poland
Phone 81216 0
+48 668 698 234
Fax 81216 0
Email 81216 0
kosowskil@wsm.opole.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Supervisor decision.


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.