Hemiparetic Cerebral Palsy ChildrenNCT05689346
High Tone Power Therapy for Hemiparetic Cerebral Palsy Children
A study testing high tone power therapy and traditional physical therapy exercises in people with Hemiparetic Cerebral Palsy Children, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy Children
- What is being tested?
- high tone power therapy and traditional physical therapy exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children will not follow instructions.
- Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
- Tightness of the hip flexors.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Hemiparetic Cerebral Palsy Children
- Being tested
- high tone power therapy, traditional physical therapy exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone power therapyDevice
high tone power therapy
traditional physical therapy exercisesOther
traditional physical therapy exercises for improving balance
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | study group will receive high tone power therapy Receives: Device: high tone power therapy |
| control group | Active comparator | children in the contol group will recieve traditional treatment for improving balance. Receives: Other: traditional physical therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change from base line at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689346
- Sponsor's protocol ID
- high tone therapy for CP.
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Tone Power Therapy Improves Balance and Quality of Life in Hemiparetic Cerebral Palsy Children: A Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05689346
- Acronym / sponsor ID
- high tone therapy for CP.
- Conditions
- Hemiparetic Cerebral Palsy Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: high tone power therapystudy group will receive high tone power therapy |
| control group | Active comparator | Other: traditional physical therapy exerciseschildren in the contol group will recieve traditional treatment for improving balance. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children will not follow instructions.
- Children with any cardiopulmonary problems, attitude and psychiatric disorders, length discrepancy; and seizures.
- Tightness of the hip flexors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high tone power therapyhigh tone power therapy | Device | study group |
| traditional physical therapy exercisestraditional physical therapy exercises for improving balance | Other | control group |
Primary outcome
balance assessment
Time frame: change from base line at 4 weeks.
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.
1 secondary outcome
quality of life assessment
Time frame: change from base line at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
Related trials for Hemiparetic Cerebral Palsy Children
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing high tone power therapy and traditional physical therapy exercises in people with Hemiparetic Cerebral Palsy Children, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa S saleh (01008342466, marwa_shafiek2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance assessment (time frame: change from base line at 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.