High Tone Power Therapy for Hemiparetic Cerebral Palsy Children

NCT05689346 | Unknown

• 1 other identifier: high tone therapy for CP.
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiparetic Cerebral Palsy Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• quality of life assessment

  change from base line at 4 weeks.

Study Arms (2)

study group

EXPERIMENTAL

study group will receive high tone power therapy

Device: high tone power therapy

control group

ACTIVE COMPARATOR

children in the contol group will recieve traditional treatment for improving balance.

Other: traditional physical therapy exercises

Interventions

high tone power therapy DEVICE

high tone power therapy

study group

traditional physical therapy exercises OTHER

traditional physical therapy exercises for improving balance

control group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children will not follow instructions.
• Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
• Tightness of the hip flexors.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

marwa S saleh

CONTACT

01008342466; marwa_shafiek2000@yahoo.com

Marwa S Saleh

CONTACT

01008342466; marwa_shafiek2000@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor doctor

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 19, 2023
• Study Start: January 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: April 15, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01