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

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: Recruiting
• Conditions: Cerebral Palsy; Hemiparesis
• Intervention / Treatment: Device: whole body vibration; Other: Functional strength training

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy; Phone Number: 01090243185; Email: amanyibrahimsabra@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
balance improvement	we will use pediatric balance scale and Biodex balance system to measure balance	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gross motor performance	we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance	3 months

Collaborators and Investigators

• Sponsor: Amany Ibrahim AbdElhamed Sabra

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Estimated): October 27, 2023

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cerebral palsy; Hemiparesis; balance; whole body vibration; functional strength training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Paresis
• Other Study ID 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