To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral PalsyNCT06086678
Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children
A study testing Conventional physical therapy, Hydrotherapy and Aerobic exercise in people with To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy, run by South Valley University at 1 site in Egypt.
Trial 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.. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy
- What is being tested?
- Conventional physical therapy, Hydrotherapy and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
- Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ragaee Saeed Mahmoud
Giza, Faisal
Ragaee Mahmoud, 00201223611112, ragaeesaeedpt10@gmail.com
Reham Mahmoud, 00201015447798, rsm_211pt@yahoo.com
About this study
Official title: Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises
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..
Read the 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.
- Being tested
- Conventional physical therapy, Hydrotherapy, Aerobic exercise
- Keywords
- Aerobic exercise; Cerebral palsy; Children; Hemiplegia; Pulmonary function
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Also called Physical therapy
- Deep breathing exercise.
- Diaphragmatic breathing exercise.
- Pursed lip breathing exercise.
HydrotherapyOther
Also called Physical therapy
- Water walking exercise.
- Forward lunges exercise.
- Single leg balance exercise.
- Side stepping exercise.
- Push ups exercise.
- Standing knee lifts exercise.
Aerobic exerciseOther
Also called Physical therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy group | Experimental | 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 Receives: Other: Conventional physical therapy |
| Hydrotherapy and conventional physical therapy group | Experimental | 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 Receives: Other: Conventional physical therapy; Other: Hydrotherapy |
| Aerobic exercise and conventional physical therapy group | Experimental | 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 Receives: Other: Conventional physical therapy; Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
Pulmonary function test
Measured: 12 consecutive weeks
Pulmonary function tests Forced expiratory volume in the first second (FEV1)
Pulmonary function test
Measured: 12 consecutive weeks
FEV1/FVC ratio
Pulmonary function test
Measured: 12 consecutive weeks
Secondary outcomes (1)
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)
Measured: 12 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaee Saeed Mahmoud, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086678
- Sponsor's protocol ID
- P.T.REC/012/004140
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises
- ClinicalTrials.gov ID
- NCT06086678
- Acronym / sponsor ID
- P.T.REC/012/004140
- Keywords
- Aerobic exercise; Cerebral palsy; Children; Hemiplegia; Pulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- random
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy group | Experimental | Other: Conventional physical therapyStrengthening 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 |
| Hydrotherapy and conventional physical therapy group | Experimental | Other: Conventional physical therapy, Other: HydrotherapyStrengthening 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 |
| Aerobic exercise and conventional physical therapy group | Experimental | Other: Conventional physical therapy, Other: Aerobic exerciseStrengthening 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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
- Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapyAlso: Physical therapy1. Deep breathing exercise. 2. Diaphragmatic breathing exercise. 3. Pursed lip breathing exercise. | Other | Aerobic exercise and conventional physical therapy group, Conventional physical therapy group, Hydrotherapy and conventional physical therapy group |
| HydrotherapyAlso: Physical therapy1. Water walking exercise. 2. Forward lunges exercise. 3. Single leg balance exercise. 4. Side stepping exercise. 5. Push ups exercise. 6. Standing knee lifts exercise. | Other | Hydrotherapy and conventional physical therapy group |
| Aerobic exerciseAlso: Physical therapyAerobic 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 | Aerobic exercise and conventional physical therapy group |
Primary outcome
Forced vital capacity (FVC)
Time frame: 12 consecutive weeks
Pulmonary function test
Pulmonary function tests Forced expiratory volume in the first second (FEV1)
Time frame: 12 consecutive weeks
Pulmonary function test
FEV1/FVC ratio
Time frame: 12 consecutive weeks
Pulmonary function test
1 secondary outcome
Six-minute walk test (6-MWT)
Time frame: 12 consecutive weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy, Hydrotherapy and Aerobic exercise in people with To Compare the Effectiveness of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function in Hemiplegic Children With Cerebral Palsy, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: 12 consecutive weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.