Whole Body Vibration Versus Functional Strength Training On Balance In Children With Hemiparetic Cerebral Palsy

October 26, 2023 updated by: Amany Ibrahim AbdElhamed Sabra

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Kafr Ash Shaykh, Egypt
        • Recruiting
        • Faculty of Physical Therapy
        • Contact:
          • faculty of physical therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The children in the study will be selected according to the following criteria:

    1. Their chronological age ranged from five to eight years old.
    2. Spasticity Grade I and II according to Modified Ashworth Scale.
    3. They will be on Level II and III according to Gross Motor Functional Classification System (GMFCS)
    4. Have the ability to walk independently.
    5. They can understand order and follow instruction.
    6. The child will be able to follow verbal commands and instructions.
    7. They can firmly grasp the rails of biodex device.

Exclusion Criteria:

  1. Children with visual or auditory problems.
  2. Children with uncontrolled convulsions.
  3. Children with fixed contractures and deformities.
  4. Children with surgical intervention less than one year.
  5. Children injected by BOTOX in the calf muscle from less than one year.
  6. Children had heart disease.
  7. Children with epilepsy.
  8. Children with severe diabetes.
  9. Children with severe vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: whole body vibration
will receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program.
Device: whole body vibration
to improve muscle power and balance.
Active Comparator: Functional strength training
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
Other: Functional strength training
used in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
balance improvement
Time Frame: 3 months
we will use pediatric balance scale and Biodex balance system to measure balance
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
gross motor performance
Time Frame: 3 months
we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amany Ibrahim AbdElhamed Sabra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EG, KFS lab Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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