Cerebral PalsyNCT02998281
Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
A study testing Threshold (IMT) in people with Cerebral Palsy and Respiration; Decreased, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Cerebral Palsy, Respiration; Decreased
- What is being tested?
- Threshold (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Dec 2017
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7-14 years
- Diagnosed to spastic cerebral palsy
- Gross Motor Function Classification System levels I or II.
- Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
- Child are able to demonstrate sufficient co-operation and cognitive understanding participating
Who cannot join
- Active medical condition impairment (pneumonia etc.)
- Do not accommodate the study
- Do not want to attempt the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06500
About this study
Official title: Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.
Read the detailed description
A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).
- Conditions
- Cerebral Palsy, Respiration; Decreased
- Being tested
- Threshold (IMT)
- Keywords
- cerebral palsy, inspiratory muscle training
- Medical subject headings
- Cerebral Palsy, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold (IMT)Device
Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load. Receives: Device: Threshold (IMT) |
| Control Group | Sham comparator | The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT. Receives: Device: Threshold (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.
Measured: 6 weeks
Secondary outcomes (5)
Activities of daily living using with Pediatric Evaluation of Disability Inventory
PEDI scale
Measured: 6 weeks
Pulmonary Function Test
spirometry
Measured: 6 weeks
Respiratory muscle strength
Mouth pressure device
Measured: 6 weeks
Functional exercise capacity
six minute walk test
Measured: 6 weeks
Change in trunk control over time assessed with Trunk Control Measurement Scale
Assessing change in trunk control
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionDec 2017
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 Gazi UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Bulent Elbasan, Phd, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998281
- Sponsor's protocol ID
- 1234
- Status last verified
- Sep 2018
- First submitted
- 10 Dec 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We have no decided yet
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02998281
- Acronym / sponsor ID
- 1234
- Conditions
- Cerebral Palsy, Respiration; Decreased
- Keywords
- cerebral palsy, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.
Detailed description
A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: Threshold (IMT)The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load. |
| Control Group | Sham comparator | Device: Threshold (IMT)The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 7-14 years
- Diagnosed to spastic cerebral palsy
- Gross Motor Function Classification System levels I or II.
- Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
- Child are able to demonstrate sufficient co-operation and cognitive understanding participating
Key exclusion criteria (3 listed)
- Active medical condition impairment (pneumonia etc.)
- Do not accommodate the study
- Do not want to attempt the study
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 |
|---|---|---|
| Threshold (IMT)Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated. | Device | Control Group, Treatment Group |
Primary outcome
Timed Up and Go Test
Time frame: 6 weeks
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.
5 secondary outcomes
Activities of daily living using with Pediatric Evaluation of Disability Inventory
Time frame: 6 weeks
Pulmonary Function Test
Time frame: 6 weeks
Respiratory muscle strength
Time frame: 6 weeks
Functional exercise capacity
Time frame: 6 weeks
Change in trunk control over time assessed with Trunk Control Measurement Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided. We have no decided yet
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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.
Bulent Elbasan, Phd study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold (IMT) in people with Cerebral Palsy and Respiration; Decreased, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: 6 weeks). 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 28 Sep 2018.