Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000390482
Ethics application status
Approved
Date submitted
7/02/2016
Date registered
24/03/2016
Date last updated
7/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of balance training on specific athletic performance in adolescents practicing football
Scientific title
Impact of balance training on specific athletic performance, abdominal muscle activity, and balance ability among children and adolescents practicing football
Secondary ID [1] 288492 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effectiveness of the exercises in sport training. 297550 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297753 297753 0 0
Physiotherapy
Musculoskeletal 297754 297754 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to normal training participants will receive following balance exercises:

1. Star exercise -
First – Tapes are placed on the ground creating the star figure.
Second - Place your right foot in the middle of the tape and the left foot is the "tapper"
Third - While maintaining your weight on the right foot, reach as far as possible with the left in all directions
Forth - Do the same with the left foot
The goal of the exercise is to reach as far as you can without losing form or balance.

2. Sitting on the Swiss ball
Lifting left upper limb with right lower limb and right upper limb with left lower limb sitting on the swiss ball in alternate manner.

3. Rolling the ball around the sensory disk:
Starting position: the subject stands with one lower limb on the disk, the second leg is set in abduction (20-30 degrees), the ball is under the foot, the hands resting on the thighs, gaze directed ahead, back straight.
Performing the exercise: the subject slowly rolls the ball around the disk with the lower limb the foot of which is on the ball.

4. Tilting the "Domyos" balance board with the lower limbs
Starting position: the subject is in lying on his back, knees bent to 90 degrees, feet stacked on the "DOMYOS" balance board, back adhering to the ground.
Performing the exercise: the subject lifts the hips up and tilts the board with his feet forward and backward, trying to keep every position for 3 seconds, then the same exercise is performed sideways - right - left and maintaining the postion for 3 seconds.

5. OrtoStabil board - squats with the ball on the board
Starting position: the subject stands on the OrtoStabil board with his feet slightly apart, his hands holding a ball (designed for football). He holds the ball in his hands in with flexed shoulder joints to a 90 degree angle and straightened elbows.
Performing the exercise: the subject performs a series of "squats" maintaining the balance of his body, keeping the angle of 90 degrees in the joints of shoulders and elbows straight.

The participants perform all of the balance exercises listed above.
The exercises will be supervised by physiotherapist in small group session. The sessions will be twice a week for 10 weeks. Each of the exercises will be performed in 4 series of 8 repeats (interval between the series - 10 seconds). The approximate duration in total of each session is 15-20 minutes.
The physiotherapist will monitors attendance at sessions by collecting information about participation in exercises.
Intervention code [1] 293940 0
Lifestyle
Intervention code [2] 293941 0
Behaviour
Comparator / control treatment
Normal sport training without additional balance exercises.
Control group
Active

Outcomes
Primary outcome [1] 297278 0
Lateral abdominal wall assessment with use ultrasound - muscle thickness
Timepoint [1] 297278 0
Baseline and after training completion (10 weeks after start of training)
Primary outcome [2] 297279 0
Stabilometric platform - body sway assessment
Timepoint [2] 297279 0
Baseline and after training completion (10 weeks after start of training)
Primary outcome [3] 297280 0
The Functional Movement Screen.
The Functional Movement Screen (FMS) is a collection of motor tests, wherein the proper execution of each of the individual tests requires the ability to perform a movement in three dimensions. The FMS evaluates the quality of the basic locomotor pattern, and any possible limitations or asymmetries in the movement patterns performed.

Explanation of the test:
1. Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther, 2006a; 1(2): 62-72
2. Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 2. N Am J Sports Phys Ther, 2006b; 1(3): 132-139
Timepoint [3] 297280 0
Baseline and after training completion (10 weeks after start of training)
Secondary outcome [1] 320573 0
Balance Error Scoring System - assessing dynamic balance and postural stability

http://knowconcussion.org/wp-content/uploads/2011/06/BESS.pdf
Timepoint [1] 320573 0
Baseline and after training completion (10 weeks after start of training)
Secondary outcome [2] 320574 0
Y Balance Test - assessing dynamic balance

https://www.youtube.com/watch?feature=player_embedded&v=MdypNR9Hx9Q
Timepoint [2] 320574 0
Baseline and after training completion (10 weeks after start of training)
Secondary outcome [3] 320575 0
Deep lumbar stability muscle assessment with use the pressure biofeedback unit (STABILIZER)
Timepoint [3] 320575 0
Baseline and after training completion (10 weeks after start of training)
Secondary outcome [4] 320576 0
Axial trunk rotation assessment with use a scoliometer
Timepoint [4] 320576 0
Baseline and after training completion (10 weeks after start of training)

Eligibility
Key inclusion criteria
Participation in football training for at least 1 years prior the study.
Minimum age
9 Years
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any surgery performed on abdomen.
Participation in any of physiotherapy treatment during last 6 months prior to the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All the participants who practise specific sport were randomised by drawing lots with the group number.
Individuals who drew the number “1” were assigned to the first group, those that drew number “2” were assigned to the second group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last participant enrolment
Anticipated
8/04/2016
Actual
8/04/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
100
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 7580 0
Poland
State/province [1] 7580 0

Funding & Sponsors
Funding source category [1] 292842 0
University
Name [1] 292842 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 292842 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
Mikolowska 72A, 40-065 Katowice, Polska
Country
Poland
Secondary sponsor category [1] 291586 0
None
Name [1] 291586 0
Address [1] 291586 0
Country [1] 291586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294345 0
Bioethical Committee at The Jerzy Kukuczka Academy of Physical Education
Ethics committee address [1] 294345 0
Ethics committee country [1] 294345 0
Poland
Date submitted for ethics approval [1] 294345 0
Approval date [1] 294345 0
12/05/2015
Ethics approval number [1] 294345 0
3/2015

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

Contacts
Principal investigator
Name 63366 0
Dr Pawel Linek
Address 63366 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 63366 0
Poland
Phone 63366 0
+48 661768601
Fax 63366 0
Email 63366 0
[email protected]
Contact person for public queries
Name 63367 0
Pawel Linek
Address 63367 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 63367 0
Poland
Phone 63367 0
+48 661768601
Fax 63367 0
Email 63367 0
[email protected]
Contact person for scientific queries
Name 63368 0
Pawel Linek
Address 63368 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 63368 0
Poland
Phone 63368 0
+48 661768601
Fax 63368 0
Email 63368 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

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