Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000149460
Ethics application status
Approved
Date submitted
25/09/2024
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of a respiratory physiotherapy program on functionality in adolescents and young adults with cerebral palsy.
Scientific title
The impact of a respiratory physiotherapy program on functionality in adolescents and young adults with cerebral palsy.
Secondary ID [1] 313044 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 335267 0
Condition category
Condition code
Neurological 331838 331838 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 332049 332049 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A program of inspiratory muscle training with a threshold device was implimented.
The participants were trained to use a device which placed resistance during inspiration and expiration. The training period lasted 1 week, without resistance. The threshold device was used by the participants. They hold the device and placed the mouthpiece between their lips and over their tongue.
Before the beginning of the measurements, the guardians of the participants and those participants who are over 14 years old signed the consent form.
Initially, measurements were performed on all research variables. The experimental group followed a 20-minute respiratory muscle exercise program using a threshold respiratory muscle device, which applied resistance during inspiration and expiration, 4 times per week. The sessions were organised in groups of 2 to 3 participants and were supervised by a physiotherapist in the premices of the collaborative schools and bodies. The resistance started at 30% of the initial Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP), in low intensity. The resistance was adjusted every 2 weeks according to the score of perceived exertion in Borg RPE scale. When the participants indicated a perceived exertion of 2 or less in Borg RPE scale the resistance increased per 5%-10%. In each session there is an attendance checklist and an exercise diary where details concerning the performance are noted, such as intensity in the threshold devise, duration of the session, Borg RPE at the end of the session.
In one month, all survey variables were re-measured.
In each session the participants are instructed to perform 10-15 breaths in the threshold device. Afterwards, there is a break of 20-30 seconds with diaphragmatic breathing and the cycle begins again.
The participants also followed the physiotherapy program of each school or body, which includes stretching, strengthening exercises, aerobic exrcise for 3-4 times per week, delivered by another physiotherapist.
The duration of the respiratory muscle training program lasts 8 weeks, and the program isimplemented 4 times each week. In total, three measurements of the variables will be performed (0, 4 and 8 weeks).
Intervention code [1] 329595 0
Treatment: Devices
Intervention code [2] 329772 0
Rehabilitation
Comparator / control treatment
The control group participated in a convetional physiotherapy program, as prescribed by the school or body program.
The convetional physiotherapy program includes stretches, muscle strengthening exercises, aerobic exercises delivered by a physiotherapist.
The physiotherapy programs for adolescents and adults with CP are individualised according to their ssessement. They include strethcing exercises to reduce spasticity in muscles, strengthening exercises in weak muscles eg. in lower limbs and aerobic exercise in static cyclo-ergometer, 20 minute session 3-4 times per week.
Control group
Active

Outcomes
Primary outcome [1] 339459 0
functionality: the body function of balance
Assessment method [1] 339459 0
Berg Balance Scale
Timepoint [1] 339459 0
bbaseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.
Primary outcome [2] 339460 0
maximum inspiratory pressure
Assessment method [2] 339460 0
a test in which individuals are asked to perform a forceful inspiration against an occluded mouthpiece with a respiratory pressure meter
Timepoint [2] 339460 0
baseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.
Primary outcome [3] 339461 0
maximum expiratory pressure
Assessment method [3] 339461 0
a test in which individuals are asked to perform a forceful respiration with a respiratory pressure meter
Timepoint [3] 339461 0
baseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.
Secondary outcome [1] 440061 0
forced expiratory volume in 1 second
Assessment method [1] 440061 0
spirometry
Timepoint [1] 440061 0
baseline, at 4 weeks and at 8 weeks, post intervention commencement
Secondary outcome [2] 440062 0
forced vital capacity
Assessment method [2] 440062 0
spirometry
Timepoint [2] 440062 0
baseline, at 4 weeks and at 8 weeks post-intervention commencent
Secondary outcome [3] 440063 0
peak expiratory force
Assessment method [3] 440063 0
spirometry
Timepoint [3] 440063 0
baseline, at 4 weeks and at 8 weeks post-intervention commencent
Secondary outcome [4] 440751 0
Primary outcome: functionality - the walking activity
Assessment method [4] 440751 0
1 minute walking distance test 6 minute walking distance test
Timepoint [4] 440751 0
baseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.
Secondary outcome [5] 440752 0
Primary outcome: functionality -the climbing activity
Assessment method [5] 440752 0
Primary outcome: functionality - 5 stairs timed stair test
Timepoint [5] 440752 0
baseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.
Secondary outcome [6] 440753 0
Primary outcome: functionality - body movement
Assessment method [6] 440753 0
5 times sit-to-stand
Timepoint [6] 440753 0
bbaseline, at 4 weeks and at 8 weeks (primary timepoint), post-intervention commencement.

Eligibility
Key inclusion criteria
a) diagnosis of cerebral pasly b) ability to understand and follow verbal commands, c) ability to walk with or without assistance (level I to III according to the gross motor function classification system)
Minimum age
13 Years
Maximum age
27 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) respiratory infection, b) level IV or V according to the gross motor function classification system, c) participation in a respiratory muscle exercise program 6 months before the study, d) participation in therapeutic approaches such as orthopedic surgery or botox injection in the last 6 months before 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)
central randomisation 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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The reliability of repeated measurements (test-retest reliability) will be checked with the index of order correlation (intraclass correlation coefficient-IR), examining the degree of correlation between the values of the dependent variables that will arise between the purposes of the measurements (0.4 and 8 weeks) for the entire sample. The level of statistical significance (p) was set at 0.05.
The interaction between intervention (experimental-control group) and time point (0, 4 and 8 weeks) for each variable separately will be examined with 2 x 4 ANOVAs (repeated measures ANOVA) and Bonferroni correction.
Independent variables will be intervention and time. Dependent variables will be the 5-times sit-to-stand, 1-minute walking distance test,6-minute walking distance test, the Berg Balance Scale score, the 5 stairs Timed stair test, as well as the MIP and MEP values and the values of the physiological indicators FEV1%, FVC and PEF.
The determination of the appropriate sample size for the examination of differences between the groups after the implementation of the intervention program was based on the effect size (effect size) of 0.85 in the research of Keles, Elbasan, Apaydin, Aribas, Bakirtas and Kokturk, (2018 ) and the corresponding tables of Whitley and Ball (2002). More specifically, with an effect size of .85, a power of .80, and a significance level of a=.05, it was calculated that the minimum sample is a total of 40 people, corresponding to 20 participants in the experimental group and 20 in the control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/11/2023
Date of last participant enrolment
Anticipated
17/02/2025
Actual
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
40
Accrual to date
34
Final
Recruitment outside Australia
Country [1] 26574 0
Greece
State/province [1] 26574 0
Attica, Athens

Funding & Sponsors
Funding source category [1] 317485 0
Charities/Societies/Foundations
Name [1] 317485 0
Open Door - Cerebral palsy Greece
Country [1] 317485 0
Greece
Primary sponsor type
University
Name
National and Kapodistrian University of Athens
Country
Greece
Secondary sponsor category [1] 319777 0
None
Name [1] 319777 0
Country [1] 319777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316198 0
Research Ethics - Bioethics Committee
Ethics committee address [1] 316198 0
Ethics committee country [1] 316198 0
Greece
Date submitted for ethics approval [1] 316198 0
16/04/2022
Approval date [1] 316198 0
20/04/2022
Ethics approval number [1] 316198 0
1377/20-04-2022

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 137110 0
Mrs Afroditi Evangelodimou
Address 137110 0
70, Sarantaporou St, Peristeri, Athens / School of Physical Education and Sport Science, 41 Ethnikis Antistasis Str., 17237, Dafni Athens
Country 137110 0
Greece
Phone 137110 0
+306977124959
Email 137110 0
aevangelodimou@uniwa.gr
Contact person for public queries
Name 137111 0
Afroditi Evangelodimou
Address 137111 0
70, Sarantaporou St, Peristeri, Athens / School of Physical Education and Sport Science, 41 Ethnikis Antistasis Str., 17237, Dafni Athens
Country 137111 0
Greece
Phone 137111 0
+306977124959
Email 137111 0
aevangelodimou@uniwa.gr
Contact person for scientific queries
Name 137112 0
Afroditi Evangelodimou
Address 137112 0
70, Sarantaporou St, Peristeri, Athens / School of Physical Education and Sport Science, 41 Ethnikis Antistasis Str., 17237, Dafni Athens
Country 137112 0
Greece
Phone 137112 0
+306977124959
Email 137112 0
aevangelodimou@uniwa.gr

Data sharing statement
Will the study consider sharing individual participant data?
No


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.