Cerebral PalsyNCT05936554
Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy
A study testing whole body vibration and Functional strength training in people with Cerebral Palsy and Hemiparesis, run by Amany Ibrahim AbdElhamed Sabra at 1 site in Egypt.
Trial summary
The study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Hemiparesis
- What is being tested?
- whole body vibration and Functional strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2023to 27 Oct 2023
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The children in the study will be selected according to the following criteria:
- Their chronological age ranged from five to eight years old.
- Spasticity Grade I and II according to Modified Ashworth Scale.
- They will be on Level II and III according to Gross Motor Functional Classification System (GMFCS)
- Have the ability to walk independently.
- They can understand order and follow instruction.
- The child will be able to follow verbal commands and instructions.
- They can firmly grasp the rails of biodex device.
Who cannot join
- Children with visual or auditory problems.
- Children with uncontrolled convulsions.
- Children with fixed contractures and deformities.
- Children with surgical intervention less than one year.
- Children injected by BOTOX in the calf muscle from less than one year.
- Children had heart disease.
Show all 9Show fewer
- Children with epilepsy.
- Children with severe diabetes.
- Children with severe vascular disease
Trial locations and contacts
1 site in 1 country.
Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Kafr ash Shaykh
faculty of physical therapy
About this study
Official title: Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy: Randomized Comparative Study
The study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis
Read the detailed description
Hemiparesis is a type of hemiplegia where mild muscle weakness causes balance disturbances because one side of the body is affected such as the arm, chest leg or face.
Muscle weakness is commonly associated with abnormal bone development, leading to increased susceptibility to fractures, most cerebral palsy children have deficits in balance, coordination, and gait throughout childhood and adulthood. So, it is essential to seek an ideal physical therapy program to help in solving such widespread problem.
Balance control is important for competence in the performance of most functional skills, helping children to recover from unexpected balance disturbances, either due to slips and trips or to self- induced instability when making a movement that brings them toward the edge of their limit of stability Whole body vibration is mechanical oscillation, defined by amplitude and frequency, generates a force that acts on whole body. It is a training method for muscle tone modulation that is increasingly used in a variety of clinical situations.
Functional strength training (FST) is an effective method of exercise therapy. It can be combined with traditional physical therapy methods and can be successfully combined with most rehabilitation and exercise equipment. It provides postural stability while promoting independence with confidence.
The current study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis.
- Conditions
- Cerebral Palsy, Hemiparesis
- Being tested
- whole body vibration, Functional strength training
- Keywords
- cerebral palsy, Hemiparesis, balance, whole body vibration, functional strength training
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
to improve muscle power and balance.
Functional strength trainingOther
used in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration | Active comparator | will receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program. Receives: Device: whole body vibration |
| Functional strength training | Active comparator | will receive Functional strength training that focuses on the movement pattern quality and treats functional movement and provides postural stability while promoting balance independence with confidence Receives: Other: Functional strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance improvement
we will use pediatric balance scale and Biodex balance system to measure balance
Measured: 3 months
Secondary outcomes (1)
gross motor performance
we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start8 Jul 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amany Ibrahim AbdElhamed Sabra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Ibrahim AbdElhamed Sabra, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936554
- Sponsor's protocol ID
- EG, KFS lab Research
- Status last verified
- Oct 2023
- First submitted
- 24 Jun 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: For assessment : Modified Ashworth scale, Gross Motor Function Classification System Expanded and Revised (GMFCS-ER), The six-minute walk test (6MWT), Biodex stability system and pediatric balance scale. For Treatment: At first both groups will receive 60 minutes of designed physical therapy program, which consisted of stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles: kneeling exercises, and standing and gait training as warming up then group I will receive whole body vibration (WBV) for 25 minutes and group II will receive functional strength training program (FST) for 30 minutes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy: Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05936554
- Acronym / sponsor ID
- EG, KFS lab Research
- Conditions
- Cerebral Palsy, Hemiparesis
- Keywords
- cerebral palsy, Hemiparesis, balance, whole body vibration, functional strength training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amany Ibrahim AbdElhamed SabraUniversity, hospital or other
- Study start
- 8 Jul 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (estimated)
- First posted
- 7 Jul 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.
The study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis
Detailed description
Hemiparesis is a type of hemiplegia where mild muscle weakness causes balance disturbances because one side of the body is affected such as the arm, chest leg or face.
Muscle weakness is commonly associated with abnormal bone development, leading to increased susceptibility to fractures, most cerebral palsy children have deficits in balance, coordination, and gait throughout childhood and adulthood. So, it is essential to seek an ideal physical therapy program to help in solving such widespread problem.
Balance control is important for competence in the performance of most functional skills, helping children to recover from unexpected balance disturbances, either due to slips and trips or to self- induced instability when making a movement that brings them toward the edge of their limit of stability Whole body vibration is mechanical oscillation, defined by amplitude and frequency, generates a force that acts on whole body. It is a training method for muscle tone modulation that is increasingly used in a variety of clinical situations.
Functional strength training (FST) is an effective method of exercise therapy. It can be combined with traditional physical therapy methods and can be successfully combined with most rehabilitation and exercise equipment. It provides postural stability while promoting independence with confidence.
The current study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole body vibration | Active comparator | Device: whole body vibrationwill receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program. |
| Functional strength training | Active comparator | Other: Functional strength trainingwill receive Functional strength training that focuses on the movement pattern quality and treats functional movement and provides postural stability while promoting balance independence with confidence |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The children in the study will be selected according to the following criteria:
Key exclusion criteria (9 listed)
- Children with visual or auditory problems.
- Children with uncontrolled convulsions.
- Children with fixed contractures and deformities.
- Children with surgical intervention less than one year.
- Children injected by BOTOX in the calf muscle from less than one year.
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 |
|---|---|---|
| whole body vibrationto improve muscle power and balance. | Device | whole body vibration |
| Functional strength trainingused in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power | Other | Functional strength training |
Primary outcome
balance improvement
Time frame: 3 months
we will use pediatric balance scale and Biodex balance system to measure balance
1 secondary outcome
gross motor performance
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Undecided. For assessment : Modified Ashworth scale, Gross Motor Function Classification System Expanded and Revised (GMFCS-ER), The six-minute walk test (6MWT), Biodex stability system and pediatric balance scale. For Treatment: At first both groups will receive 60 minutes of designed physical therapy program, which consisted of stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles: kneeling exercises, and standing and gait training as warming up then group I will receive whole body vibration (WBV) for 25 minutes and group II will receive functional strength training program (FST) for 30 minutes
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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.
Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and Functional strength training in people with Cerebral Palsy and Hemiparesis, run by Amany Ibrahim AbdElhamed Sabra 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 8 inclusion and 9 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 30 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?
Contact Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy (01090243185, amanyibrahimsabra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance improvement (time frame: 3 months). 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 30 Oct 2023.