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Trial registered on ANZCTR
Registration number
ACTRN12616001681448
Ethics application status
Approved
Date submitted
14/11/2016
Date registered
6/12/2016
Date last updated
9/03/2020
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of physiotherapy in different sensory disturbances in selected peripheral neuropathies
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Scientific title
Effectiveness of physiotherapy in different sensory disturbances in selected peripheral neuropathies
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Secondary ID [1]
290497
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None
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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:
Peripheral neuropathies
300887
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Condition category
Condition code
Physical Medicine / Rehabilitation
300705
300705
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0
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Physiotherapy
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Neurological
300867
300867
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention group (neurodynamic techniques) - gliding and tension neurodynamic techniques of peripheral nerve (upper limb, lower limb), one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
Upper limb:
a. medial nerve – position supine, neurodynamic sequence: arm adduction 90 degree and external rotation, wrist and finger extension, forearm supination, elbow extension; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – elbow extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist extension – small amplitude of motion et the end of the movement)
b. ulnar nerve - position supine, neurodynamic sequence: wrist and finger extension, forearm pronation, arm external rotation, elbow flection, arm adduction; one-direction proximal glide mobilisation (movement – arm adduction –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – arm adduction –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist extension – small amplitude of motion et the end of the movement)
c. radial nerve – position supine, neurodynamic sequence: elbow extension, arm interial rotation, wrist flexion, arm adduction and extension; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – elbow extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist flexion – small amplitude of motion et the end of the movement)
Lower limb:
a. tibial nerve - position supine, neurodynamic sequence: feet extension and pronation, knee extension, hip flexion (SLR – straight leg raise); one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
b. peroneal nerve - position supine, neurodynamic sequence: feet flexion and supination, knee extension, hip flexion (SLR – straight leg raise), hip abduction; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion at the end of the movement)
c. femoral nerve - position side lying, neurodynamic sequence: maximum hip and knee flection of untested lower limb, hip extension and knee flexion of tested lower limb; one-direction proximal glide mobilisation (movement – hip extension –large amplitude of motion), one-direction distal glide mobilisation (movement – knee flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – hip extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – knee flexion – small amplitude of motion at the end of the movement).
Standard protocol consisted of three series of 60 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 s, twice a week for 10 sessions.
The intervention will be delivered by experienced in neurodynamic techniques physiotherapist..
The intervention will be performed in two outpatient clinic in Silesia region of Poland.
The duration of the each therapy session is 45 min.
Therapy will be performed on peripheral nerves in lower and upper limb in patients with toxic or/and diabetic neuropathies, All participants receive all six nerve treatments.
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Intervention code [1]
296395
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Rehabilitation
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Intervention code [2]
296396
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Treatment: Other
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Comparator / control treatment
Arm 1 - Placebo group - (placebo treatment) – sham gliding and tension neurodynamic techniques of peripheral nerve (upper limb, lower limb), one-direction proximal and distal glide mobilisation and one-direction proximal and distal tension mobilisation.
Upper limb:
d. medial nerve – position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – elbow extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist extension – small amplitude of motion et the end of the movement)
e. ulnar nerve - position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – arm adduction –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – arm adduction –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist extension – small amplitude of motion et the end of the movement)
f. radial nerve – position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – elbow extension –large amplitude of motion), one-direction distal glide mobilisation (movement – wrist flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – elbow extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – wrist flexion – small amplitude of motion et the end of the movement)
Lower limb:
d. tibial nerve - position supine, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
e. peroneal nerve - position supine, without neurodynamic sequence – upper extremity in neutral position, hip abduction; one-direction proximal glide mobilisation (movement – knee extension –large amplitude of motion), one-direction distal glide mobilisation (movement – feet extension –large amplitude of motion), one-direction proximal tension mobilisation (movement – knee extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – feet extension – small amplitude of motion et the end of the movement)
f. femoral nerve - position side lying, without neurodynamic sequence – upper extremity in neutral position; one-direction proximal glide mobilisation (movement – hip extension –large amplitude of motion), one-direction distal glide mobilisation (movement – knee flexion –large amplitude of motion), one-direction proximal tension mobilisation (movement – hip extension –small amplitude of motion et the end of the movement), one-direction distal tension mobilisation (movement – knee flexion – small amplitude of motion et the end of the movement).
Standard protocol consisted of three series of 60 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 s, twice a week for 10 sessions.
Arm 2 -Control group – no treatment
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Control group
Placebo
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Outcomes
Primary outcome [1]
300184
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neuropathy symptom score
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Assessment method [1]
300184
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Timepoint [1]
300184
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baseline and week 5 (following completion of 10 sessions)
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Primary outcome [2]
300185
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nerve conduction study will be performed by specialists in an independent, off-site electromyography (EMG) laboratory and prescribed by the treating physician.
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Assessment method [2]
300185
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Timepoint [2]
300185
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baseline and week 5 (following completion of 10 sessions)
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Primary outcome [3]
300186
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two point discrimination sensation - Dellon discriminator
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Assessment method [3]
300186
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Timepoint [3]
300186
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baseline and week 5 (following completion of 10 sessions)
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Secondary outcome [1]
329267
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sensation threshold - semmes-weinstein monofilaments
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Assessment method [1]
329267
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Timepoint [1]
329267
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baseline and week 5 (following completion of 10 sessions)
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Secondary outcome [2]
329268
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vibration - Rydel-Seiffer tuning-fork
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Assessment method [2]
329268
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Timepoint [2]
329268
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baseline and week 5 (following completion of 10 sessions)
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Secondary outcome [3]
329269
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kinaesthetic differentiation of strenght - grip dynamometer and pinch dynamometer, kinaesthetic platform
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Assessment method [3]
329269
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Timepoint [3]
329269
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baseline and week 5 (following completion of 10 sessions)
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Secondary outcome [4]
329270
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pain (Laitinen scale, numerical pain scale)
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Assessment method [4]
329270
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Timepoint [4]
329270
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baseline and week 5 (following completion of 10 sessions)
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Eligibility
Key inclusion criteria
- Peripheral neuropathy diagnosed by physican
- Subjective and objective symptoms of peripheral neuropathy
- Consent to participate in research
- No contraindications to therapy
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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
- Pharmacological therapy which may affect the sensory disturbances
- Cervical myelopathy
- Cervical and lumbar radiculopathy
- Rheumatoid diseases
- Pregnancy
- Fibromyalgia
- 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 will be randomised by drawing lots with the group number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/12/2016
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Actual
20/02/2017
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Date of last participant enrolment
Anticipated
29/06/2018
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Actual
21/01/2019
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Date of last data collection
Anticipated
31/05/2019
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Actual
11/06/2019
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Sample size
Target
300
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Accrual to date
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Final
318
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Recruitment outside Australia
Country [1]
8390
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Poland
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State/province [1]
8390
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Silesia
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Funding & Sponsors
Funding source category [1]
294966
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University
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Name [1]
294966
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The Jerzy Kukuczka Academy of Physical Education in Katowice
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Address [1]
294966
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Poland, 40-065, Mikolowska 72B
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Country [1]
294966
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Poland
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Primary sponsor type
University
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Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
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Address
Poland, 40-065, Mikolowska 72B Katowice
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Country
Poland
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Secondary sponsor category [1]
293786
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None
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Name [1]
293786
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Address [1]
293786
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Country [1]
293786
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296325
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Bioethics Committee for Scientific Studies at the Physical Education College of Katowice
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Ethics committee address [1]
296325
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Poland, 40-065, Mikolowska 72A, Katowice
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Ethics committee country [1]
296325
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Poland
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Date submitted for ethics approval [1]
296325
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15/05/2016
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Approval date [1]
296325
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23/06/2016
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Ethics approval number [1]
296325
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Decision No. 4/2016
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Summary
Brief summary
Assess the effectiveness of neurodynamic treatment in the conservative treatment of peripheral neuropathies. We hypothesised that the use of neurodynamic treatment would be effective in the treatment of peripheral neuropathies.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
1228
1228
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/AnzctrAttachments/371810-Scan komisja pdf.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
70298
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Dr Tomasz Wolny
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Address
70298
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
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Country
70298
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Poland
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Phone
70298
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+48 604820416
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Fax
70298
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Email
70298
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[email protected]
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Contact person for public queries
Name
70299
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Pawel Linek
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Address
70299
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
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Country
70299
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Poland
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Phone
70299
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+48661768601
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Fax
70299
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Email
70299
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[email protected]
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Contact person for scientific queries
Name
70300
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Pawel Linek
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Address
70300
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The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland,
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Country
70300
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Poland
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Phone
70300
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+48661768601
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Fax
70300
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Email
70300
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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