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Trial registered on ANZCTR
Registration number
ACTRN12625000460404
Ethics application status
Approved
Date submitted
18/01/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of self-implemented sliding versus tensioning neurodynamic techniques on objective and subjective parameters in adults with carpal tunnel syndrome.
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Scientific title
Effect of self-implemented sliding versus tensioning neurodynamic techniques on objective and subjective parameters in adults with carpal tunnel syndrome.
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Secondary ID [1]
313755
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome
336355
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Condition category
Condition code
Physical Medicine / Rehabilitation
332889
332889
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm.1 – Group 1 (manual therapy) –carpal tunnel syndrome treatment will use manual therapy based on self-implemented sliding neurodynamic techniques. The therapy will be performed independently by the patient in the form of self-therapy.
a. Sliding neurodynamic techniques for median nerve; position supine; neurodynamic sequence: arm adduction 90 degree and external rotation, wrist and finger extension, forearm supination, elbow extension; neurodynamic technique: one-direction proximal slide mobilisation (movement – rhythmically elbow flexion and extension –large amplitude of motion), one-direction distal slide mobilisation (movement – rhythmically wist flexion and extension –large amplitude of motion).
Physiotherapist will be providing instructions to enable participants to self-implement the techniques, the level of intensity – moderate, standard protocol consisted of ten series of 60 repetitions neurodynamic techniques separated by inter-series intervals of 1 minute. The duration of one therapy session will be approximately 30 minutes. The session will be performed in the patient’s home. Strategies used to assess or monitor adherence to the intervention – exercise diaries, reminder and telephone check-up by a physiotherapist.
The therapy will be administered 5 times a week for 2 weeks (10 therapeutic sessions in total).
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Intervention code [1]
330336
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Rehabilitation
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Comparator / control treatment
Arm.2 – Group 2 (manual therapy) –carpal tunnel syndrome treatment will use manual therapy based on self-implemented tensioning neurodynamic techniques. The therapy will be performed independently by the patient in the form of self-therapy.
a. Tensioning neurodynamic techniques for median nerve; position supine; neurodynamic sequence: arm adduction 90 degree and external rotation, wrist and finger extension, forearm supination, elbow extension; neurodynamic technique: one-direction proximal slide mobilisation (movement – rhythmically elbow flexion and extension – small amplitude of motion et the end of the movement), one-direction distal slide mobilisation (movement – rhythmically wist flexion and extension – small amplitude of motion et the end of the movement).
Physiotherapist will be providing instructions to enable participants to self-implement the techniques, the level of intensity – moderate, standard protocol consisted of ten series of 60 repetitions neurodynamic techniques separated by inter-series intervals of 1 minute. The duration of one therapy session will be approximately 30 minutes. The session will be performed in the patient’s home. Strategies used to assess or monitor adherence to the intervention – exercise diaries, reminder and telephone check-up by a physiotherapist.
The therapy will be administered 5 times a week for 2 weeks (10 therapeutic sessions in total).
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Control group
Active
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Outcomes
Primary outcome [1]
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Nerve conduction study
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Assessment method [1]
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Examinations of nerve conduction will be performed in the electromyography laboratory by experienced personnel. The examination will be performed by an antidromic method, with superficial electrodes. Nerve conduction study will be performed on median nerve.
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Timepoint [1]
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Baseline, 1 week post completion of treatment (primary timepoint), 6 months follow-up post treatment.
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Primary outcome [2]
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Ultrasound test (surface area, share wave elastography)
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Assessment method [2]
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Ultrasound examinations will be performed in the ultrasound and elastography laboratory by experienced personnel. The examination will be performed by Hologic Supersonic Mach 30 ultrasound scanner (Supersonic Imagine, Aix En Provence, France) using a linear transducer array (5–18 MHz; Super Linear SL18-5, Supersonic Imagine).
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Timepoint [2]
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Baseline, 1 day post completion of treatment (primary timepoint), 6 months follow-up post treatment.
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Primary outcome [3]
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Pain assessment
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Assessment method [3]
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Numerical pain rating scale - NPRS
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Timepoint [3]
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Baseline, 1 day post completion of treatment (primary timepoint), 6 months follow-up post treatment.
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Secondary outcome [1]
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Assessment of subjective symptoms
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Assessment method [1]
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Boston Carpal Tunnel Questionnaire
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Timepoint [1]
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Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.
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Secondary outcome [2]
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Muscle strength
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Assessment method [2]
443988
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The use of a dynamometer according to our own developed methodology
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Timepoint [2]
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Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.
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Secondary outcome [3]
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Two-point discrimination sense
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Assessment method [3]
443989
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Study according to our own methodology taken from the assessment of carpal tunnel syndrome (CTS) patients. Pads of the first three fingers from the palmar side using Dellon discriminator
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Timepoint [3]
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Before treatment, after treatment, 6 month follow-up
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Secondary outcome [4]
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Cutaneous sensory perceptron threshold
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Assessment method [4]
443990
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Study according to our own methodology taken from the assessment of CTS patients by Pads of the first three fingers from the palmar side using Semmes–Weinstein-type monofilaments
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Timepoint [4]
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Before treatment, after treatment, 6 month follow-up
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Secondary outcome [5]
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Kinesthetic differentiation of muscle strength
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Assessment method [5]
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The use of a dynamometer according to our own developed methodology
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Timepoint [5]
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Before treatment, after treatment, 6 month follow-up
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Secondary outcome [6]
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Assessment functional status
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Assessment method [6]
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Boston Carpal Tunnel Questionnaire
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Timepoint [6]
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Baseline, 1 day post completion of treatment, 6 months follow-up post treatment.
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Eligibility
Key inclusion criteria
- Carpal tunnel syndrome diagnosed clinically and neurophysiologically by specialist
- Subjective and objective symptoms of carpal tunnel syndrome
- No other diseases that could affect the test results
- No contraindications to therapy
- Consent to participate in research
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Lack of consent
- Lack of cooperation from the patient
- Contraindications to therapy
- No symptoms of carpal tunnel syndrome
- Previous surgical treatment
- Other causes of symptoms
- Mental illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients diagnosed with carpal tunnel syndrome who met the diagnostics criteria will be eligible for the study. Each consecutive patient who will meet the inclusion criteria will be randomly assigned to the experimental or control group. Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The basic parameters will be compared between groups using the independent t-test (age, body mass, height, BMI – kilograms per square meter) and the chi2 test (gender distribution, side of hand dominance etc.). A one-way ANOVA for repeated measurements (independent factor was group: “experimental” versus “control”, and repeated factor on time: before therapy versus after therapy) will be used in order to evaluate the differences in carpal tunnel syndrome nerve conduction study, ultrasound test, pain assessment, subjective symptoms and functional status, strength, ,kinaesthetic differentiation of strength, two point discrimination, cutaneous sensory perceptron threshold, overall health status. For significant differences in the main effect for group, time Or interaction (group x time), post hoc test will be used. The results will be presented as the mean and 95% confidence interval (CI). For all analyses, the threshold of the P value considered as significant will be set at <0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last participant enrolment
Anticipated
1/11/2025
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26831
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Poland
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State/province [1]
26831
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Funding & Sponsors
Funding source category [1]
318208
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University
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Name [1]
318208
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The Jerzy Kukuczka Academy of Physical Education in Katowice
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Address [1]
318208
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Country [1]
318208
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Poland
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Primary sponsor type
Government body
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Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
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Address
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Country
Poland
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Secondary sponsor category [1]
320597
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None
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Name [1]
320597
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Address [1]
320597
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Country [1]
320597
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316858
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Bioethics Committee for Scientific Research of the Jerzy Kukuczka Academy of Physical Education in Katowice
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Ethics committee address [1]
316858
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Katowice, Poland, 40-065, Mikolowska 72A
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Ethics committee country [1]
316858
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Poland
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Date submitted for ethics approval [1]
316858
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01/03/2023
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Approval date [1]
316858
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29/06/2023
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Ethics approval number [1]
316858
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Summary
Brief summary
Assess the effectiveness of manual therapy including sliding versus tensioning neurodynamic techniques in the conservative treatment of carpal tunnel syndrome. We hypothesised that the use of sliding and tensioning neurodynamic techniques would be effective in the treatment of carpal tunnel syndrome.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Tomasz Wolny
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Address
139222
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
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Country
139222
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Poland
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Phone
139222
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+48604820416
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Fax
139222
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Email
139222
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[email protected]
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Contact person for public queries
Name
139223
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Tomasz Wolny
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Address
139223
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
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Country
139223
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Poland
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Phone
139223
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+48604820416
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Fax
139223
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Email
139223
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[email protected]
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Contact person for scientific queries
Name
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Tomasz Wolny
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Address
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B
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Country
139224
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Poland
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Phone
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+48604820416
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Fax
139224
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Email
139224
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
No possibility to share personal data in the European Union.
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24462
Ethical approval
Bioetyczna 2023 002.jpg
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.
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