- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396289
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
June 27, 2018 updated by: Büşra Kepenek Varol, Bezmialem Vakif University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34093
- Bezmialem Vakif University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cerebral palsy diagnosis
- Children with level I or II according to Gross Motor Classification System
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
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.
|
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.
|
Experimental: Training Group
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.
|
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.
Threshold IMT device will be used for the training.
Training intensity will set at 30% of the maximum inspiratory pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline maximum inspiratory pressure at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline maximum expiratory pressure at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2018
Primary Completion (Actual)
June 25, 2018
Study Completion (Actual)
June 25, 2018
Study Registration Dates
First Submitted
January 5, 2018
First Submitted That Met QC Criteria
January 5, 2018
First Posted (Actual)
January 10, 2018
Study Record Updates
Last Update Posted (Actual)
June 28, 2018
Last Update Submitted That Met QC Criteria
June 27, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvubkvarol01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy, Spastic
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
-
Burke Medical Research InstituteUniversity of Minnesota; Teachers College, Columbia UniversityRecruitingCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Hemiplegic Cerebral Palsy | Spastic Hemiplegia | Spastic HemiparesisUnited States
-
Riphah International UniversityRecruitingCerebral Palsy Spastic DiplegiaPakistan
-
Universitat de LleidaNot yet recruitingCerebral Palsy, SpasticSpain
-
Riphah International UniversityCompleted
-
Sahmyook UniversityCompletedCerebral Palsy | Gait Disorders, Neurologic | Spastic Hemiplegic Cerebral Palsy | Bilateral Spastic Cerebral PalsyKorea, Republic of
-
Sanko UniversityCompletedCerebral Palsy | Gait, Hemiplegic | Gait, Spastic | Hemiplegic Cerebral Palsy | Cerebral Palsy Spastic DiplegiaTurkey
-
Kahramanmaras Sutcu Imam UniversityCompletedCerebral Palsy | Upper Extremity Dysfunction | Muscle Strength | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Upper Extremity FunctionsTurkey
Clinical Trials on Conventional physiotherapy including balance exercises
-
Prof. Dan JustoRecruiting
-
University of ValenciaAsociación Parkinson ValenciaEnrolling by invitation
-
King Saud UniversityCompleted
-
Riphah International UniversityNot yet recruitingAdhesive CapsulitisPakistan
-
Riphah International UniversityRecruiting
-
Fundació Institut de Recerca de l'Hospital de la...Parc de Salut Mar; Universitat Internacional de Catalunya; Hospital de Terrassa; Hospital Parc Taulí, Sabadell and other collaboratorsTerminatedPhysical Activity | Stroke Syndrome | Sequelae | Brain Injury, Vascular | Movement; Disorder, Treatment-InducedSpain
-
Uskudar UniversityMarmara UniversityCompletedCerebral Palsy Spastic DiplegiaTurkey
-
Ankara Yildirim Beyazıt UniversityCompleted
-
Cairo UniversityCompleted
-
Riphah International UniversityCompleted