CClinicalTrials.gg
Status unknownNCT05689346Updated Jan 25, 2023

High Tone Power Therapy for Hemiparetic Cerebral Palsy Children

An interventional study of high tone power therapy and traditional physical therapy exercises in Hemiparetic Cerebral Palsy Children, sponsored by Cairo University. Status unknown. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemiparetic Cerebral Palsy Children

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03

In context

Cerebral Palsy

1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's planned enrollment of 64 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    study group

    study group will receive high tone power therapy

    Device: 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

Interventions

  • Devicehigh tone power therapy

    high tone power therapy

  • Othertraditional physical therapy exercises

    traditional physical therapy exercises for improving balance

06

What researchers measure

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.

    Time frame: change from base line at 4 weeks.

Secondary outcomes

  1. 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.

    Time frame: change from base line at 4 weeks.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05689346
Lead sponsor
Cairo University
Responsible party
Marwa Shafiek Mustafa Saleh (assistance professor doctor, Cairo University) — Principal investigator
First posted
Jan 19, 2023
Start date
Jan 15, 2023 (estimated)
Primary completion
Mar 15, 2023 (estimated)
Completion
Apr 15, 2023 (estimated)
Last update
Jan 25, 2023

Study contacts

marwa S saleh
Contact
marwa_shafiek2000@yahoo.com
01008342466
Marwa S Saleh
Contact
marwa_shafiek2000@cu.edu.eg
01008342466

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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