High Tone Power Therapy for Hemiparetic Cerebral Palsy Children

High Tone Power Therapy Improves Balance and Quality of Life in Hemiparetic Cerebral Palsy Children: A Randomized, Double Blind, Placebo-controlled Trial

Balance reactions and postural control are inadequate in children with CP which affect their daily living activities. So, different treatment modalities have been used to improve balance for cerebral palsy children. Recently, High tone power therapy is a new quantum leap in the field of electro therapy that can be used to stimulate nerves and muscles, so this randomized controlled study will be conducted to investigate the effect of high tone power therapy on balance and quality of life in hemiparetic cerebral palsy children.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiparetic Cerebral Palsy Children
• Intervention / Treatment: Device: high tone power therapy; Other: traditional physical therapy exercises

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marwa S saleh; Phone Number: 01008342466; Email: marwa_shafiek2000@yahoo.com
• Study Contact Backup: Name: Marwa S Saleh; Phone Number: 01008342466; Email: marwa_shafiek2000@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Age ranged from 6 to 8 years.
• Height not less than one meter.
• Their spasticity will range from 1 to 1+ according to the Modified Ashworth Scale.
• Children have normal flexibility of the lower back muscles as adequate flexibility with normal muscle length is essential for proper joint function and efficient movement.
• Exclusion criteria:
• Children will not follow instructions.
• Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
• Tightness of the hip flexors.

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
Experimental: study group; study group will receive high tone power therapy	Device: high tone power therapy; high tone power therapy
Active Comparator: control group; children in the contol group will recieve traditional treatment for improving balance.	Other: traditional physical therapy exercises; traditional physical therapy exercises for improving balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
balance assessment	biodex balance system will be used to assess the dynamic balance: Before the evaluation procedures all children will be given an explanatory session to be aware about the different test steps, also the support rails and biofeedback display screen will be adjusted for each child to ensure comfort and safety during the test procedure, then each child will be trained 1 min for adaptation to the machine. During the test, children will be instructed to stand on the platform in the most comfortable posture, and maintain their visual level by focusing straight ahead on the monitor. The platform will be unlocked and children will be allowed to adjust their foot placement until a comfortable standing position will be achieved while they simultaneously maintained a moving pointer at the center point on the monitor and children will be encouraged to maintain the moving pointer at the center point throughout the test.	change from base line at 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life assessment	The Pediatric Quality of Life Inventory (PedsQL) is a questionnaire assessment tool used to evaluate HRQOL in children. It is composed of 23 items that gauge function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL.	change from base line at 4 weeks.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2023
• Primary Completion (Anticipated): March 15, 2023
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: high tone therapy for CP.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No