Back to resultsHigh Tone Power Therapy for Hemiparetic Cerebral Palsy Children
Primary Purpose
Hemiparetic Cerebral Palsy Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high tone power therapy
traditional physical therapy exercises
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparetic Cerebral Palsy Children
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
study group will receive high tone power therapy
children in the contol group will recieve traditional treatment for improving balance.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05689346
Brief Title
High Tone Power Therapy for Hemiparetic Cerebral Palsy Children
Official Title
High Tone Power Therapy Improves Balance and Quality of Life in Hemiparetic Cerebral Palsy Children: A Randomized, Double Blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparetic Cerebral Palsy Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
study group will receive high tone power therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
children in the contol group will recieve traditional treatment for improving balance.
Intervention Type
Device
Intervention Name(s)
high tone power therapy
Intervention Description
high tone power therapy
Intervention Type
Other
Intervention Name(s)
traditional physical therapy exercises
Intervention Description
traditional physical therapy exercises for improving balance
Primary Outcome Measure Information:
Title
balance assessment
Description
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.
Time Frame
change from base line at 4 weeks.
Secondary Outcome Measure Information:
Title
quality of life assessment
Description
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.
Time Frame
change from base line at 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa S saleh
Phone
01008342466
Email
marwa_shafiek2000@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa S Saleh
Phone
01008342466
Email
marwa_shafiek2000@cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
High Tone Power Therapy for Hemiparetic Cerebral Palsy Children
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