Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001147875
Ethics application status
Approved
Date submitted
23/09/2020
Date registered
26/08/2021
Date last updated
4/04/2024
Date data sharing statement initially provided
26/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of myofascial release of the diaphragm and chest on the functional parameters of the lungs and characteristics of the abdominal muscles and diaphragm in children with cerebral palsy: Randomized clinical trials
Scientific title
The effects of myofascial release of the diaphragm and chest on the functional parameters of the lungs and characteristics of the abdominal muscles and diaphragm in children with cerebral palsy: Randomized clinical trials
Secondary ID [1] 302306 0
None
Universal Trial Number (UTN)
U1111-1258-2737
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 319067 0
respiratory disease 319068 0
Condition category
Condition code
Respiratory 317019 317019 0 0
Other respiratory disorders / diseases
Neurological 317020 317020 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Myofascial release of the diaphragm and chest
What: Two techniques will be proposed in the project.
Arm 1. The patient is lying down on their back, with limbs relaxed; in the case of individuals with contractures, the position will be secured by a roller or wedge. The therapist will be standing behind the patient’s head and will place their hands on the rib arch. The manual contact of both hands with the patient will occur from the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the therapist’s forearms aligned toward the participant’s shoulders. During inhalation, the therapist will press gently with both hands in an upward and slightly lateral direction, which will be accompanied by elevation of the ribs. During exhalation, the therapist will deepen the pressure towards the inside of the body cavity, maintaining constant pressure and resistance. In subsequent cycles, the therapist will gradually increase the depth of contact on the edge of the ribs. This manoeuvre will be performed in two cycles of ten deep inhalations and exhalations. There must be a 1-minute break between cycles. In the control group, sham therapy will be used, in which there is no traction or resistance components.
Arm 2. The patient will still be lying down on their back. The therapist will try to hold the costal arches of the patient with their hands. A gentle pressure in the dorsal direction will activate the sternum area of the diaphragm. The pressure of the hand will be adjusted according tothe rhythm of the respiratory system, deepening at each exhalation. The technique will be repeated in two cycles of ten deep inhalations and exhalations. There must be a 1-minute break between cycles.
Who provided: The therapist performing the therapeutic techniques for the study will be an individual with long-term experience of working with myofascial techniques. This person will not be directly involved in the project and will not be familiar with the details of the study or the procedures.
How: The therapeutic intervention will be performed face to face, the therapist will use his or her hand while performing the therapeutic techniques. The specificity of the method of mysofascial release assumes individual work with the participant. The approximate duration of each session, 30 minutes. In addition, an attendance list will be signed at each therapy session and examination to accurately monitor attendance at each scheduled therapy session.

Where: The research will be carried out in rehabilitation centres and at the Jerzy Kukuczka Academy of Physical Education in Katowice. Special Primary School No. 23 in Jastrzebie-Zdroj, the Complex of Special Schools for Mother Teresa of Calcutta in Zory, Rehabilitation Centres in Zory, Jastrzebie-Zdroj, Rybnik.
When: Children with CP will be randomly assigned to experimental and control groups. The experimental group will receive six sessions of therapy (myofascial release of the diaphragm and chest) whereas the control group will receive six sessions of placebo therapy. The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment. The myofascial release therapy will be performed at intervals of 3-4 days. The intervention will be applied twice a week for 3 weeks, total 6 sessions.
Intervention code [1] 318599 0
Rehabilitation
Comparator / control treatment
The control (placebo) will have the same duration of therapy. The positioning of the therapist's hands will be not different from experimental group. However, the therapies will be devoid of the components of traction, compression and pressure changes under the influence of the respiratory cycle. Both the experimental and the control (placebo) therapy will be performed at the same intervals. The same therapist will perform the technique.
Control group
Placebo

Outcomes
Primary outcome [1] 325174 0
Diaphragm thickness at the end of inspiration and expiration.

Ultrasound imaging will be used for the measurements, based on methodology from:
Linek, P. Wolny, T. Sikora, D. Klepek, A. (2019). Supersonic Shear Imaging for Quantification of Lateral Abdominal Muscle Shear Modulus in Pediatric Population with Scoliosis: A Reliability and Agreement Study. Ultrasound in Medicine and Biology. 45(7) 1551–1561
Timepoint [1] 325174 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment.
Primary outcome [2] 325175 0
Forced vital capacity (FVC),

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [2] 325175 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Primary outcome [3] 327415 0
Maximal inspiratory pressure (MIP)

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [3] 327415 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [1] 387087 0
Change Quality of life (health-related quality of life) using:

The Paediatric Quality of Life Inventory (PedsQL)
https://www.pedsql.org/
Timepoint [1] 387087 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [2] 387213 0
Change Quality of life (health-related quality of life) using:

The St. George’s Respiratory Questionnaire (SGRQ)
Timepoint [2] 387213 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [3] 395014 0
Abdominal muscle thickness at rest and during inspiration and expiration;

Ultrasound imaging will be used for the measurements, based on methodology from: Flatres A. et al. (2020) Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit care. 2020;24(1):34
Timepoint [3] 395014 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [4] 395015 0
Abdominal muscle elasticity at rest and during inspiration and expiration.

Ultrasound imaging will be used for the measurements, based on methodology from: Flatres A. et al. (2020) Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit care. 2020;24(1):34
Timepoint [4] 395015 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [5] 395016 0
Diaphragmatic motion;

Ultrasound imaging will be used for the measurements, based on methodology from:
Linek, P. Wolny, T. Sikora, D. Klepek, A. (2019). Supersonic Shear Imaging for Quantification of Lateral Abdominal Muscle Shear Modulus in Pediatric Population with Scoliosis: A Reliability and Agreement Study. Ultrasound in Medicine and Biology. 45(7) 1551–1561
Timepoint [5] 395016 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment.
Secondary outcome [6] 395017 0
Diaphragm excursion

Ultrasound imaging will be used for the measurements, based on methodology from:
Linek, P. Wolny, T. Sikora, D. Klepek, A. (2019). Supersonic Shear Imaging for Quantification of Lateral Abdominal Muscle Shear Modulus in Pediatric Population with Scoliosis: A Reliability and Agreement Study. Ultrasound in Medicine and Biology. 45(7) 1551–1561
Timepoint [6] 395017 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment.
Secondary outcome [7] 395018 0
Maximal expiratory pressure (MEP)

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [7] 395018 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [8] 395019 0
Peak expiratory flow (PEF),

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [8] 395019 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [9] 395020 0
Forced expiratory volume in one second (FEV1),

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [9] 395020 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment
Secondary outcome [10] 395021 0
Ratio Forced expiratory volume in one second and forced vital capacity (FEV1/FVC),

The measurement will be perform by a spirometer, following the methodology from:
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. PMID: 31613151; PMCID: PMC6794117.
Timepoint [10] 395021 0
The measurements will be taken before treatment, after the first treatment and after the sixth treatment, as well as one month after the end of the experiment

Eligibility
Key inclusion criteria
1. Cerebral palsy diagnosed by neurologist.
2. The ability to understand and execute instructions in order to perform all tests.
Minimum age
9 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Transient diseases (e.g. colds, flu)
2. Any prior surgery on the chest and trunk.
3. Recent (within 3 months) history of botulinum administration
4. No consent to participate in the study or refusal to participate during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be by CENTRAL RANDOMISATION BY COMPUTER.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All study data will be calculated by one-way ANOVA for repeated measurements with the between-subject factor being ‘group’ (experimental vs. control) and repeated measurements being ‘time of the experiment’(baseline data vs. data after therapy). For results showing significant differences in the main effect, a post hoc Bonferroni test will be calculated. Results will be presented as means and 95% confidence intervals. For all analyses, the threshold of the P value considered as significant will be set at <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 22997 0
Poland
State/province [1] 22997 0

Funding & Sponsors
Funding source category [1] 306735 0
University
Name [1] 306735 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 306735 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
ul. Mikolowska 72A
40-065 Katowice
Country
Poland
Secondary sponsor category [1] 307284 0
None
Name [1] 307284 0
Address [1] 307284 0
Country [1] 307284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306906 0
Komisja Bioetyczna ds. Badan Naukowych Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Ethics committee address [1] 306906 0
Ethics committee country [1] 306906 0
Poland
Date submitted for ethics approval [1] 306906 0
20/05/2020
Approval date [1] 306906 0
09/07/2020
Ethics approval number [1] 306906 0
Decision No. 9/2020

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

Contacts
Principal investigator
Name 105402 0
Miss Magdalena Domin
Address 105402 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland
Country 105402 0
Poland
Phone 105402 0
+48516184275
Fax 105402 0
Email 105402 0
[email protected]
Contact person for public queries
Name 105403 0
Magdalena Domin
Address 105403 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland
Country 105403 0
Poland
Phone 105403 0
+48516184275
Fax 105403 0
Email 105403 0
[email protected]
Contact person for scientific queries
Name 105404 0
Pawel Linek
Address 105404 0
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland, 40-065, Mikolowska 72B, Poland
Country 105404 0
Poland
Phone 105404 0
+48661768601
Fax 105404 0
Email 105404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be shared: all of the individual participant data collected during the trial, after de-identification; anonymous data. Additionally, parents can obtain data on their child.

Combined participants data (anonymous) will be publish in an article and the detailed data (anonymous) will be available on the request.
When will data be available (start and end dates)?
Data will be made available at the conclusion of the study, upon request for up to 5 years.
Available to whom?
Parents of participants and researchers who provide a methodologically sound proposalwill be able to access this data.
Available for what types of analyses?
The data will be available for IPD meta-analysesand information for parents of participans.
How or where can data be obtained?
Data will be shared subject to approvals by Principal Investigator (provide email [email protected])


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.