- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502274
Effect of Respiratory Strength on Trunk Control (rehabilitation)
Effect of Respiratory Muscle Strengthening on Dynamic Trunk Control in Children With Diplegia
Purpose:The purpose of the study was to evaluate the effectiveness of respiratory muscle strengthening on trunk control in children with spastic diplegic cerebral palsy .
Subjects and Methods: Thirty children with spastic diplegic cerebral palsy aged from 8to 10 years selected with impaired trunk control and respiratory problems .They have spasticity degree of 1 to 2 according to modified Ashwarth scale. classified into 2 equal groups: control and study. Evaluation w by trunk control measurement scale and spirometer test pre and post treatment.Both groups will receive conventional program designed for diplegic cerebral palsy children in addition to incentive spirometer for study group and breathing exercises for control group for 1hour, three times per week for 1 month .
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusive criteria:
- Children age ranged from 8 to 10 years old.
- They were diagnosed as spastic diplegic cerebral palsy.
- They had spasticity grade from1 to 2 according to modified Ashwarthe scale(appendix-II)(Balzer et al ,.2018) .
- They had trunk control problems according to trunk control measurement scale (appendix-III)(Heyrman et al., 2011) .
- They are able to follow orders and instructions.
- They have respiratory function problems.
Exclusive criteria:
Children excluded if they had any of the following issues:
- Having fixed deformities at lower limbs which affects sitting abilities.
- Recent spine or lower limb surgeries or lower limbs Botox injection in the last six months before the study .
- Moderate to sever scoliosis or spinal deformities.
- Chest infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
regular respiratory exercises
|
respiratory training by spirometer in addition to trunk control exercises
|
|
Experimental: study
respiratory training by spirometer
|
respiratory training by spirometer in addition to trunk control exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
respiratory function
Time Frame: pre and after 1 month
|
maximum inspiratory and expiratory volume
|
pre and after 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
trunk control
Time Frame: pre and post 1 month
|
trunk control as a gross motor function
|
pre and post 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- trunk control rehabilitation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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