Cerebral Palsy, SpasticNCT03396289
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
A study testing Conventional physiotherapy including balance exercises and Inspiratory muscle training in people with Cerebral Palsy, Spastic, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Conventional physiotherapy including balance exercises and Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2018to 25 Jun 2018
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral palsy diagnosis
- Children with level I or II according to Gross Motor Classification System
Who cannot join
- Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
- Severe convulsions that can not be controlled by drugs
- Congenital malformation accompanying cerebral palsy
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated. Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children. Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP. However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training. Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance. Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development. Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP. The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Conventional physiotherapy including balance exercises, Inspiratory muscle training
- Keywords
- Cerebral Palsy, Balance, Inspiratory Muscle Training, 6-Minute Walk Test, Pulmonary Function Test, Postural Stability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapy including balance exercisesOther
Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
Inspiratory muscle trainingOther
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home. Receives: Other: Conventional physiotherapy including balance exercises |
| Training Group | Experimental | In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home. Receives: Other: Conventional physiotherapy including balance exercises; Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline maximum inspiratory pressure at 8 weeks
Measured: Eight weeks
Change from baseline maximum expiratory pressure at 8 weeks
Measured: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Measured: Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Measured: Eight weeks
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start23 Feb 2018
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kepenek Varol, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396289
- Sponsor's protocol ID
- bvubkvarol01
- Status last verified
- Jun 2018
- First submitted
- 5 Jan 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03396289
- Acronym / sponsor ID
- bvubkvarol01
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral Palsy, Balance, Inspiratory Muscle Training, 6-Minute Walk Test, Pulmonary Function Test, Postural Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 10 Jan 2018 (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 a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated. Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children. Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP. However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training. Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance. Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development. Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP. The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional physiotherapy including balance exercisesPatients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home. |
| Training Group | Experimental | Other: Conventional physiotherapy including balance exercises, Other: Inspiratory muscle trainingIn addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Cerebral palsy diagnosis
- Children with level I or II according to Gross Motor Classification System
Key exclusion criteria (3 listed)
- Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
- Severe convulsions that can not be controlled by drugs
- Congenital malformation accompanying cerebral palsy
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 |
|---|---|---|
| Conventional physiotherapy including balance exercisesProgramme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision. | Other | Control Group, Training Group |
| Inspiratory muscle trainingThreshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure. | Other | Training Group |
Primary outcome
Change from baseline maximum inspiratory pressure at 8 weeks
Time frame: Eight weeks
Change from baseline maximum expiratory pressure at 8 weeks
Time frame: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Time frame: Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time frame: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time frame: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time frame: Eight weeks
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time frame: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time frame: Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Time frame: Eight 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 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy including balance exercises and Inspiratory muscle training in people with Cerebral Palsy, Spastic, run by Bezmialem Vakif 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 2 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 Jun 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. 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?
Change from baseline maximum inspiratory pressure at 8 weeks (time frame: Eight weeks). The study lists 9 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 28 Jun 2018.