Cerebral Palsy (CP)NCT07351292
Ultrasound or Whole Body Vibration on Knee Motion and Function in CP
A study testing ultrasound and whole body vibration in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
Trial summary
This study compared the efficacy of therapeutic ultrasound (US) and whole-body vibration (WBV) as adjuncts to a standardized passive stretching regimen on improving knee joint range of motion (ROM) and functional capacity in children with hemiplegic cerebral palsy (HCP). Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- ultrasound and whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2025to 12 Aug 2025
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 4-6 years
- knee flexion deformity due to hamstring tightness
- Gross Motor Function Classification System (GMFCS) levels I or II
- spasticity grade of 1 or 2 on the modified Ashworth Scale
Who cannot join
- other causes of knee flexion deformity
- previous orthopedic knee surgery
- significant visual, auditory, or perceptual deficits
- uncontrolled seizures; or acute illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Therapeutic Ultrasound and Whole-body Vibration as Adjuncts to Passive Stretching on Knee Joint Range of Motion and Functional Ability in Children With Hemiplegic Cerebral Palsy.
This study compared the efficacy of therapeutic ultrasound (US) and whole-body vibration (WBV) as adjuncts to a standardized passive stretching regimen on improving knee joint range of motion (ROM) and functional capacity in children with hemiplegic cerebral palsy (HCP).
Read the detailed description
Sixty children with HCP, aged 4-6 years, were randomly assigned to one of two groups. Both groups received passive stretching of the hamstrings and plantar flexors three times per week for twelve weeks. The control group (US group) received therapeutic ultrasound prior to stretching, while the research group (WBV group) performed exercises on a vibrating platform before stretching. Active knee extension ROM was measured with a digital goniometer, and functional ability was assessed using the Gross Motor Function Measure-88 (GMFM-88) at baseline and post-intervention.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- ultrasound, whole body vibration
- Keywords
- Ultrasound, whole-body vibration, knee range of motion, functional ability, children, hemiplegia, cerebral palsy
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Received continuous ultrasound (1 MHz, 1.0 W/cm², 5 min per hamstring) using a Chattanooga Intelect Mobile 2 unit with a medium-sized transducer head and coupling gel
whole body vibrationDevice
Performed exercises on a Power Plate Pro 5 vibration platform. Parameters were set to a frequency of 20 Hz and a fixed amplitude of 2 mm (peak-to-peak displacement). The child maintained a semi-squat posture (approximately 30 knee flexion) for two 5-minute bouts separated by a 1-minute rest.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound group | Experimental | received therapeutic ultrasound prior to stretching Receives: Device: ultrasound |
| whole body vibration group | Experimental | performed exercises on a vibrating platform before stretching Receives: Device: whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Extension Range of Motion (ROM)
Measured using an Absolute + Axis™ Digital Goniometer. With the child supine and pelvis stabilized, the goniometer axis was aligned with the lateral femoral condyle. The stationary arm was aligned with the greater trochanter, and the moving arm with the lateral malleolus. The child was instructed to actively extend the knee as far as possible, and the angle was recorded. Three measurements were taken, and the average was used for analysis
Measured: 12 weeks
2. Gross Motor Function
Assessed using the Gross Motor Function Measure-88 (GMFM-88), a validated observational tool for children with CP. A blinded assessor, not involved in the intervention, scored the children's performance. The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines
contained in the manual be used for scoring each item.
SCORING KEY 0 = does not initiate
- = initiates
- = partially completes
- = completes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start6 Mar 2025
- Primary completion30 Apr 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
- Investigators
- mostafa S ali, PhD, Principal investigator, associate professor for pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351292
- Sponsor's protocol ID
- P.T.REC/012/006029
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Therapeutic Ultrasound and Whole-body Vibration as Adjuncts to Passive Stretching on Knee Joint Range of Motion and Functional Ability in Children With Hemiplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07351292
- Acronym / sponsor ID
- P.T.REC/012/006029
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Ultrasound, whole-body vibration, knee range of motion, functional ability, children, hemiplegia, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 20 Jan 2026 (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.
This study compared the efficacy of therapeutic ultrasound (US) and whole-body vibration (WBV) as adjuncts to a standardized passive stretching regimen on improving knee joint range of motion (ROM) and functional capacity in children with hemiplegic cerebral palsy (HCP).
Detailed description
Sixty children with HCP, aged 4-6 years, were randomly assigned to one of two groups. Both groups received passive stretching of the hamstrings and plantar flexors three times per week for twelve weeks. The control group (US group) received therapeutic ultrasound prior to stretching, while the research group (WBV group) performed exercises on a vibrating platform before stretching. Active knee extension ROM was measured with a digital goniometer, and functional ability was assessed using the Gross Motor Function Measure-88 (GMFM-88) at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| ultrasound group | Experimental | Device: ultrasoundreceived therapeutic ultrasound prior to stretching |
| whole body vibration group | Experimental | Device: whole body vibrationperformed exercises on a vibrating platform before stretching |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age from 4-6 years
- knee flexion deformity due to hamstring tightness
- Gross Motor Function Classification System (GMFCS) levels I or II
- spasticity grade of 1 or 2 on the modified Ashworth Scale
Key exclusion criteria (4 listed)
- other causes of knee flexion deformity
- previous orthopedic knee surgery
- significant visual, auditory, or perceptual deficits
- uncontrolled seizures; or acute illness
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 |
|---|---|---|
| ultrasoundReceived continuous ultrasound (1 MHz, 1.0 W/cm², 5 min per hamstring) using a Chattanooga Intelect Mobile 2 unit with a medium-sized transducer head and coupling gel | Device | ultrasound group |
| whole body vibrationPerformed exercises on a Power Plate Pro 5 vibration platform. Parameters were set to a frequency of 20 Hz and a fixed amplitude of 2 mm (peak-to-peak displacement). The child maintained a semi-squat posture (approximately 30 knee flexion) for two 5-minute bouts separated by a 1-minute rest. | Device | whole body vibration group |
Primary outcome
Active Knee Extension Range of Motion (ROM)
Time frame: 12 weeks
Measured using an Absolute + Axis™ Digital Goniometer. With the child supine and pelvis stabilized, the goniometer axis was aligned with the lateral femoral condyle. The stationary arm was aligned with the greater trochanter, and the moving arm with the lateral malleolus. The child was instructed to actively extend the knee as far as possible, and the angle was recorded. Three measurements were taken, and the average was used for analysis
2. Gross Motor Function
Time frame: 12 weeks
Assessed using the Gross Motor Function Measure-88 (GMFM-88), a validated observational tool for children with CP. A blinded assessor, not involved in the intervention, scored the children's performance. The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
mostafa S ali, PhD principal investigator
associate professor for pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and whole body vibration in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Extension Range of Motion (ROM) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 21 Jan 2026.