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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05936554
Other study ID # EG, KFS lab Research
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 8, 2023
Est. completion date October 27, 2023

Study information

Verified date October 2023
Source Kafrelsheikh University
Contact Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy
Phone 01090243185
Email amanyibrahimsabra@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 27, 2023
Est. primary completion date October 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
whole body vibration
to improve muscle power and balance.
Other:
Functional strength training
used in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power

Locations

Country Name City State
Egypt Faculty of Physical Therapy Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Amany Ibrahim AbdElhamed Sabra

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary balance improvement we will use pediatric balance scale and Biodex balance system to measure balance 3 months
Secondary gross motor performance we will use Gross Motor Function Measure 88 (GMFM-88) to measure gross motor performance 3 months
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