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

Sponsor
South Valley University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086678
Collaborator
(none)
3
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3
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Study Details

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..

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional physical therapy
  • Other: Hydrotherapy
  • Other: Aerobic exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomrandom
Masking:
Single (Outcomes Assessor)
Masking Description:
single
Primary Purpose:
Treatment
Official Title:
Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Jan 20, 2024

Arms and Interventions

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: Conventional physical therapy
Deep breathing exercise. Diaphragmatic breathing exercise. Pursed lip breathing exercise.
Other Names:
  • Physical therapy
  • 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: Conventional physical therapy
    Deep breathing exercise. Diaphragmatic breathing exercise. Pursed lip breathing exercise.
    Other Names:
  • Physical therapy
  • Other: Hydrotherapy
    Water walking exercise. Forward lunges exercise. Single leg balance exercise. Side stepping exercise. Push ups exercise. Standing knee lifts exercise.
    Other Names:
  • Physical therapy
  • 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: Conventional physical therapy
    Deep breathing exercise. Diaphragmatic breathing exercise. Pursed lip breathing exercise.
    Other Names:
  • Physical therapy
  • Other: Aerobic exercise
    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:
  • Physical therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Forced vital capacity (FVC) [12 consecutive weeks]

      Pulmonary function test

    2. Pulmonary function tests Forced expiratory volume in the first second (FEV1) [12 consecutive weeks]

      Pulmonary function test

    3. FEV1/FVC ratio [12 consecutive weeks]

      Pulmonary function test

    Secondary Outcome Measures

    1. Six-minute walk test (6-MWT) [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:
    1. 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).

    2. Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ragaee Saeed Mahmoud Giza Faisal Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ragaee Saeed Mahmoud, Lecturer, South Valley University
    ClinicalTrials.gov Identifier:
    NCT06086678
    Other Study ID Numbers:
    • P.T.REC/012/004140
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ragaee Saeed Mahmoud, Lecturer, South Valley University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 17, 2023