Cerebral PalsyNCT06640686
The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
A study testing Exercise training in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
Trial summary
Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 4 and 12 years
- Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
- Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
- Ability to cooperate during the exercises
Who cannot join
- Presence of acute or chronic respiratory diseases
- Presence of acute medical conditions
- History of active epilepsy
- Scoliosis with a Cobb angle greater than 30 degrees
- Presence of chest deformities
- Severe visual and hearing impairments
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Walking, and Functional Independence in Children With Cerebral Palsy
Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.
Read the detailed description
In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.
- Conditions
- Cerebral Palsy
- Being tested
- Exercise training
- Keywords
- respiratory function test, muscle strength, gait, trunk
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Inspiratory muscle training for increase strength of inspiratory muscle.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device. Receives: Other: Exercise training |
| Traditional Physiotherapy Group | Active comparator | The control group will receive the traditional physical therapy program. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PP Check device
respiratory muscle strength will assess with device that called 'RP Check'.
Measured: 6 months
spirometer
respiratory function test will be assess with spirometer.
Measured: 6 months
trunk control mesurement scale
trunk control will assess with Trunk Control Measurement Scale.
Measured: 6 months
10 m walking test
gait speed will assess with 10 meter walking test
Measured: 6 months
2 minutes walking test
gait endurance will assess with 2 minutes walking test.
Measured: 6 months
WeeFIM scale
functional independence will assess with WeeFIM scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Gamze Aydin, Istanbul University - Cerrahpasa
- Investigators
- Gamze Aydın, PhD, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640686
- Sponsor's protocol ID
- IstanbulOkanUniv
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Walking, and Functional Independence in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06640686
- Acronym / sponsor ID
- IstanbulOkanUniv
- Conditions
- Cerebral Palsy
- Keywords
- respiratory function test, muscle strength, gait, trunk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.
Detailed description
In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Other: Exercise trainingInspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device. |
| Traditional Physiotherapy Group | Active comparator | Other: Exercise trainingThe control group will receive the traditional physical therapy program. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 4 and 12 years
- Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
- Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
- Ability to cooperate during the exercises
Key exclusion criteria (6 listed)
- Presence of acute or chronic respiratory diseases
- Presence of acute medical conditions
- History of active epilepsy
- Scoliosis with a Cobb angle greater than 30 degrees
- Presence of chest deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingInspiratory muscle training for increase strength of inspiratory muscle. | Other | Inspiratory Muscle Training Group, Traditional Physiotherapy Group |
Primary outcome
PP Check device
Time frame: 6 months
respiratory muscle strength will assess with device that called 'RP Check'.
spirometer
Time frame: 6 months
respiratory function test will be assess with spirometer.
trunk control mesurement scale
Time frame: 6 months
trunk control will assess with Trunk Control Measurement Scale.
10 m walking test
Time frame: 6 months
gait speed will assess with 10 meter walking test
2 minutes walking test
Time frame: 6 months
gait endurance will assess with 2 minutes walking test.
WeeFIM scale
Time frame: 6 months
functional independence will assess with WeeFIM scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Aydın, PhD principal investigator
Okan University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Aydın, PhD (05377600256 ext. +90, gamze.tosun@okan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PP Check device (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.