- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086678
Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children
Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Faisal
-
Giza, Faisal, Egypt
- Recruiting
- Ragaee Saeed Mahmoud
-
Contact:
- Ragaee Mahmoud
- Phone Number: 00201223611112
- Email: ragaeesaeedpt10@gmail.com
-
Contact:
- Reham Mahmoud
- Phone Number: 00201015447798
- Email: rsm_211pt@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages ranged from 8 to 16 years.
- Belonged to levels I to II of the Gross Motor Function Classification System (GMFCS).
- Spasticity ranged from grade 1 to grade 1+ according to Modified Ashwarth Scale. - Able to walk, no impairment of sensation or other neurological or psychological problems.
- Clinically and medically stable and able to understand and follow the instructions
Exclusion Criteria:
i) Visual and/or auditory defects. ii) Significant shortening and/or deformity of lower extremities. iii) Other neurological problems that affect balance or mentality (e.g. epilepsy) iv) Advanced radiographic alterations comprise (bone destruction, bony ankylosis, knee joint sublaxation as well as epiphysial fracture).
v) Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conventional physical therapy group
Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises
|
Other Names:
|
|
Experimental: Hydrotherapy and conventional physical therapy group
Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises in addition to hydrotherapy
|
Other Names:
Other Names:
|
|
Experimental: Aerobic exercise and conventional physical therapy group
Strengthening exercises, stretching exercises for the weak and tightened muscles respectively, facilitation of equilibrium and protective reactions and breathing exercises in form of Deep breathing, Diaphragmatic breathing and Pursed lip breathing exercises in addition to aerobic exercise
|
Other Names:
Aerobic exercise in form of treadmill training when each child was standing on the treadmill, should be ensure that this standing in an upright position, and according to each child, the therapist corrected the height of the handrails.
Ask the child to keep looking forwards along the walking on the treadmill aiming to encourage the setting of walking free.
The treadmill training would be completed for each child when the child completes three stages in 1-min training cycles.
First stage: the child grasped on to the rails with both hands in first 15 s of every 1-min.
Second stage: the child grasped on to the railings with one hand in the second 15 s.
And final stage: the child didn't grasp on to the railings in last 30 s.
Every child performed this procedure twenty times
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced vital capacity (FVC)
Time Frame: 12 consecutive weeks
|
Pulmonary function test
|
12 consecutive weeks
|
|
Pulmonary function tests Forced expiratory volume in the first second (FEV1)
Time Frame: 12 consecutive weeks
|
Pulmonary function test
|
12 consecutive weeks
|
|
FEV1/FVC ratio
Time Frame: 12 consecutive weeks
|
Pulmonary function test
|
12 consecutive weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walk test (6-MWT)
Time Frame: 12 consecutive weeks
|
It assesses exercise capacity objectively and determine prognosis in many respiratory (such as COPD, idiopathic pulmonary fibrosis, and pulmonary hypertension) and non-respiratory conditions (such as heart failure)
|
12 consecutive weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004140
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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