Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001316594
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
2/12/2015
Date last updated
7/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of NEURAC stability training on specific athletic performance and abdominal muscle activity among children and adolescents practicing volleyball
Scientific title
Impact of NEURAC stability training on FMS score, specific athletic performance and lateral abdominal muscle activity among children and adolescents practicing volleyball.
Secondary ID [1] 287403 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. 296109 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296366 296366 0 0
Physiotherapy
Musculoskeletal 296368 296368 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 exercises:

Arm 1.
NEURAC training - All exercises were conducted in closed kinematic chains on slings placed on the gym horizontal bar and ladders. The exercises were prepared to easily implement them in normal volleyball training. The order and description of exercises are as follows:
1. Blocking exercises:
A) Starting position (SP): The player is lying face down, the upper limbs bent at the elbows, hands placed on slings, body is in one line. Movement: lifting the torso up (in line) with the movement of elbows straightening. At the beginning, the subjects are supported on their knees, and in the next training they supported on their toes.
B) SP: as Above. Movement: moving the upper limbs forward. As a modification, a sensorimotor pillow was introduced to the exercise, under the toes.
C) SP: The player is lying back, the upper limbs bent at the elbows, hands on slings, lower limbs based on the heels. Movement: lifting the torso up, straightening the elbows and lifting the upper limbs.

2. Attack exercises:
A) SP: The player is face down, his hands on slings, body in a straight line, supported on the toes. Movement: the practitioner raises up the trunk, raising a hand in front.
B) SP: The player is kneeling straight (knees on a sensorimotor pillow), hands on slings, arms in internal rotation. Movement: sweeping work by attacking upper limb.

The exercises were carried out two times a week for eight weeks. Each exercise was performed in two series of eight repetitions. In each repetition, the subjects had to keep the ending position for three seconds. Between sets of exercises there was a five-minute break.. The exercises lasted about 20 minutes. The training was performed by professional trainer in small group. It was a supervised training. Register of attendance at sessions was conducted.
Intervention code [1] 292757 0
Treatment: Other
Intervention code [2] 292758 0
Rehabilitation
Comparator / control treatment
Normal sport training without additional NEURAC exercises.
Control group
Active

Outcomes
Primary outcome [1] 296014 0
Lateral abdominal wall assessment with use ultrasound - muscle thickness
Timepoint [1] 296014 0
Baseline and after training completion
Primary outcome [2] 296015 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 [2] 296015 0
Baseline and after training completion (8 weeks)
Primary outcome [3] 296016 0
Deep lumbar stability muscle assessment with use the pressure biofeedback unit (STABILIZER)
Timepoint [3] 296016 0
Baseline and after training completion
Secondary outcome [1] 317232 0
Standing long jump
Timepoint [1] 317232 0
Baseline and after training completion.
Secondary outcome [2] 318894 0
Vertical Jump Test
Timepoint [2] 318894 0
Baseline and after training completion.

Eligibility
Key inclusion criteria
Participation in volleyball training for at least 2 years prior the study.
Lack of low back pain during last 12 months prior to the study.
Lack of scoliosis.
Minimum age
9 Years
Maximum age
18 Years
Sex
Both males and females
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.
Participation in volleyball training fewer than 2 years prior 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The necessary sample size was assessed based on preliminary results on 10 participants. Calculation of sample size was based on a alpha of 0.05, a statistical power of 0.80. Based on this calculation we aimed to recruit 40 patients for each treatment group. Due to that, necessary sample size should be more than 80 (control and experimental groups). Taking into account some problems with participants (potential injury, disease, refusal from experiment later in study) we decided to recruit about 50 patients for each group.

Analysis of variance for repeated measurements.
The critical p level was set at 0,05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2016
Actual
4/01/2016
Date of last participant enrolment
Anticipated
30/04/2016
Actual
29/01/2016
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7134 0
Poland
State/province [1] 7134 0
Silesia

Funding & Sponsors
Funding source category [1] 291970 0
University
Name [1] 291970 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 291970 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] 290638 0
None
Name [1] 290638 0
Address [1] 290638 0
Country [1] 290638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293466 0
Bioethical Committee at The Jerzy Kukuczka Academy of Physical Education
Ethics committee address [1] 293466 0
Ethics committee country [1] 293466 0
Poland
Date submitted for ethics approval [1] 293466 0
Approval date [1] 293466 0
12/05/2015
Ethics approval number [1] 293466 0
3/2015

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

Contacts
Principal investigator
Name 60034 0
Dr Pawel Linek
Address 60034 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 60034 0
Poland
Phone 60034 0
+48 661768601
Fax 60034 0
Email 60034 0
[email protected]
Contact person for public queries
Name 60035 0
Pawel Linek
Address 60035 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 60035 0
Poland
Phone 60035 0
+48 661768601
Fax 60035 0
Email 60035 0
[email protected]
Contact person for scientific queries
Name 60036 0
Pawel Linek
Address 60036 0
The Jerzy kukuczka Academy of Physical Education, Katowicach, ul.
Mikolowska 72A, 40-065 Katowice
Country 60036 0
Poland
Phone 60036 0
+48 661768601
Fax 60036 0
Email 60036 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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Documents added automatically
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