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Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children

Primary Purpose

To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional physical therapy
Hydrotherapy
Aerobic exercise
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy focused on measuring Aerobic exercise; Cerebral palsy; Children; Hemiplegia; Pulmonary function

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ragaee Saeed MahmoudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional physical therapy group

Hydrotherapy and conventional physical therapy group

Aerobic exercise and conventional physical therapy group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Forced vital capacity (FVC)
Pulmonary function test
Pulmonary function tests Forced expiratory volume in the first second (FEV1)
Pulmonary function test
FEV1/FVC ratio
Pulmonary function test

Secondary Outcome Measures

Six-minute walk test (6-MWT)
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)

Full Information

First Posted
October 11, 2023
Last Updated
October 16, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT06086678
Brief Title
Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children
Official Title
Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral palsy (CP) is the most common motor disability in childhood. Respiratory muscle weakness and a low upper to lower chest diameter ratio are common respiratory dysfunction manifestations in those children which negatively affect their quality of life..
Detailed Description
Objective: To compare the effectiveness of hydrotherapy versus aerobic exercise on pulmonary function in hemiplegic children with cerebral palsy. Methods: Sixty hemiplegic children (both genders) took part in this research, they were between the ages of 8 to 16, moreover, they were split equally between three groups (A, B and C). The three groups participated in the same conventional physical therapy, group (A) received conventional physical therapy only, group (B) received hydrotherapy, while group (C) received aerobic exercise. Pulmonary function tests are measured by Six-minute walk test (6-MWT) and Spirometer to measure Forced vital capacity (FVC), Forced expiratory volume in the first second (FEV1) as well as FEV1/FVC ratio for all children before the beginning and after the end of this study, the treatment program was applied three sessions per week for 12 consecutive weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy
Keywords
Aerobic exercise; Cerebral palsy; Children; Hemiplegia; Pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
random
Masking
Outcomes Assessor
Masking Description
single
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy group
Arm Type
Experimental
Arm Description
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
Arm Title
Hydrotherapy and conventional physical therapy group
Arm Type
Experimental
Arm Description
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
Arm Title
Aerobic exercise and conventional physical therapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
Physical therapy
Intervention Description
Deep breathing exercise. Diaphragmatic breathing exercise. Pursed lip breathing exercise.
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Other Intervention Name(s)
Physical therapy
Intervention Description
Water walking exercise. Forward lunges exercise. Single leg balance exercise. Side stepping exercise. Push ups exercise. Standing knee lifts exercise.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
Physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
Pulmonary function test
Time Frame
12 consecutive weeks
Title
Pulmonary function tests Forced expiratory volume in the first second (FEV1)
Description
Pulmonary function test
Time Frame
12 consecutive weeks
Title
FEV1/FVC ratio
Description
Pulmonary function test
Time Frame
12 consecutive weeks
Secondary Outcome Measure Information:
Title
Six-minute walk test (6-MWT)
Description
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)
Time Frame
12 consecutive weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ragaee Saeed Mahmoud
City
Giza
State/Province
Faisal
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragaee Mahmoud
Phone
00201223611112
Email
ragaeesaeedpt10@gmail.com
First Name & Middle Initial & Last Name & Degree
Reham Mahmoud
Phone
00201015447798
Email
rsm_211pt@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children

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