Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000393459
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
24/03/2016
Date last updated
15/06/2021
Date data sharing statement initially provided
15/06/2021
Date results information initially provided
15/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of exercise on the relationship between deep muscles asymmetry and lumbopelvic kinematics in healthy women
Scientific title
Effect of exercise on the relationship between deep muscles asymmetry and lumbopelvic kinematics in healthy women
Secondary ID [1] 288633 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle asymmetry in the lumbopelvic region 297800 0
Condition category
Condition code
Musculoskeletal 297978 297978 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 297979 297979 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The women participated in this study will be reported to the laboratory for one visit lasting 2-3 hours. They all will be assessed by one physiotherapist, which will perform standard ortopeadic manual tests and standard physiotherapeutic functional assessment of lumbopelvic complex. Then the quality and symmetry od motion between right and left side will be measured during gait and during functional tascs e.g ascending/descending stairs. Simultaneously with the motion analysis the muscles bioelectrical activity of lumbar, abdominal and lower limbs muscles will be assessed. After it, in supine lying position the pelvic floor muscles activity during Glazer test and deep muscles evaluation by transabdominal ultrasonography will be performed. All subjects will recieve one 20 minutes session of trunk and pelvis muscles exercise, which may stimulate the normalisation of neuromotor control during contraction of muscles in lumbopelvic complex. All exercise will be administrated by one physiotherapists during one-on-one consultation. All measurements will be performed at baseline and immediately after the exercise.
Intervention code [1] 294041 0
Diagnosis / Prognosis
Intervention code [2] 294042 0
Prevention
Intervention code [3] 294043 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297499 0
Relationship between deep muscles asymmetry and lumbopelvic kinematics - assessed by surface electromyography (sEMG), motion analisys 3D and ultrasonography.
Timepoint [1] 297499 0
Baseline and immediately after exercise
Primary outcome [2] 297500 0
Influence of trunk and pelvis muscles exercise on lumbopelvic asymmetry - assessed by surface electromyography (sEMG), motion analisys 3D and ultrasonography
Timepoint [2] 297500 0
Baseline and immediately after exercise
Secondary outcome [1] 321231 0
Changes in lumbopelvic asymmetry and in functional mobility evaluated by standard ortopeadic manual tests and standard physiotherapeutic functional assessment.
Timepoint [1] 321231 0
Baseline and immediately after exercise
Secondary outcome [2] 321232 0
Changes in symmetry of muscles bioelectrical activity in lumbopelvic complex during standard functional tests as walking, ascending/descending stairs - assessed by surface electromyography (sEMG)
Timepoint [2] 321232 0
Baseline and immediately after exercise
Secondary outcome [3] 321233 0
Changes in pelvic floor muscles symmetry - assessed by surface electromyography with vaginal electrode during the Glazer test
Timepoint [3] 321233 0
Baseline and immediately after exercise
Secondary outcome [4] 321234 0
Changes in the symmetry of movement between body sides evaluated during gait, during spinal motion in sagittal , frontal and transverse planes and during ascending/descending stairs. Assessed by 3D kinematics with motion capture system.
Timepoint [4] 321234 0
Baseline and immediately after exercise
Secondary outcome [5] 321235 0
Changes in deep muscles symmetry in lumbopelvic complex - assessed by transabdominal ultrasonography (USG)
Timepoint [5] 321235 0
Baseline and immediately after exercise

Eligibility
Key inclusion criteria
good health
average level of physical activity
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
professional athleticism
chronic diseases of locomotor system, nervous system and cardiovascular system
sensory disorders
varicoceles of anus and vulva
pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/06/2015
Date of last participant enrolment
Anticipated
Actual
31/08/2018
Date of last data collection
Anticipated
Actual
30/11/2018
Sample size
Target
100
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 7624 0
Poland
State/province [1] 7624 0

Funding & Sponsors
Funding source category [1] 292991 0
Self funded/Unfunded
Name [1] 292991 0
Country [1] 292991 0
Primary sponsor type
Individual
Name
prof Anna Mika
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 291765 0
None
Name [1] 291765 0
Address [1] 291765 0
Country [1] 291765 0
Other collaborator category [1] 278857 0
University
Name [1] 278857 0
Institute of Physiotherapy, Faculty of Medicine, University of Rzeszow, Poland
Address [1] 278857 0
ul. Warszawska 26A
35-205 Rzeszow
Country [1] 278857 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294499 0
The Ethical Committee of University of Rzeszow, Poland
Ethics committee address [1] 294499 0
ul. Warszawska 26A
35-205 Rzeszow
Ethics committee country [1] 294499 0
Poland
Date submitted for ethics approval [1] 294499 0
Approval date [1] 294499 0
21/01/2015
Ethics approval number [1] 294499 0
4/01/2015

Summary
Brief summary
The presence of deep muscles asymmetry at rest and during movement is considered as sign of lumbopelvic region dysfunction. Very often severe asymmetry between right and left side is one of the criteria of the eligibility of the patient for surgery. The asymmetry in muscles work, strength and length is also considered as strong risk factor of musculosceletal injury. Moreover the standard rehabilitation applicated in those patients is not always successful. The reason of this failure may be the misdiagnosis based on traditional interpretation of pelvic floor muscles ultrasonographic evaluation, without consideration of evaluated deep muscles function, and motion in which they are active. Therefore it is important to extend the functional evaluation of deep lumbopelvic muscles by simultaneous assessment of their bioelectrical activity in specific functional tascs, their shape and symmetry at rest and during movement visible in ultrasonography and the influance of deep muscles contraction quality on motion symmetry in lumbopelvic region visible e.g. during gait.
The aim of this study is the evaluation of the relationship between deep muscles asymmetry of lumbopelvic region and the quality of motion kinematics in pelvis, spine and lower limbs. We also would like to assess the influence of trunk and pelvis muscles exercise on the quality of movement and on muscles activity in lumbopelvic complex.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63938 0
Prof Anna Mika
Address 63938 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63938 0
Poland
Phone 63938 0
+48 12 6831134
Fax 63938 0
+48 12 6831300
Email 63938 0
[email protected]
Contact person for public queries
Name 63939 0
Prof Anna Mika
Address 63939 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63939 0
Poland
Phone 63939 0
+48 12 6831134
Fax 63939 0
+48 12 6831300
Email 63939 0
[email protected]
Contact person for scientific queries
Name 63940 0
Prof Anna Mika
Address 63940 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63940 0
Poland
Phone 63940 0
+48 12 6831134
Fax 63940 0
+48 12 6831300
Email 63940 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Oleksy L, Mika A, Kielnar R, Grzegorczyk J, Marche... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe influence of pelvis reposition exercises on pelvic floor muscles asymmetry2019https://doi.org/10.1097/md.0000000000013988
N.B. These documents automatically identified may not have been verified by the study sponsor.