Cerebral Palsy (CP)NCT06600984
WBV on Fascicle Lenght and Knee Joint Angle in CP
A study testing whole body vibration and designed physiotherapy program in people with Cerebral Palsy (CP), run by Cairo University at 1 site in Egypt.
Trial summary
This study investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy 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?
- whole body vibration and designed physiotherapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2023to 10 Nov 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages varied from four to six years of both sex
- hemiplegic CP children, were suffering from knee joint flexion deformity due to hamstring muscles tightness
- Level I and II motor function, according to the Growth Motor Function Classification System (GMFC) expanded and revised
- Degree of spasticity ranged from 1 to 2 according to modified Ashworth scale
- All children received neuro-developmental techniques
Who cannot join
- Other causes of knee flexion deformities
- Previous history of orthopedic surgery in knee joint
- Visual or auditory problems
- Seizures
- Sensory or perceptual deficits
- Any acute illness at the time of collection of data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Whole Body Vibration on Fascicle Length and Joint Angle in Children With Hemiplegic Cerebral Palsy
This study investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy
Read the detailed description
to study the effect of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy
- Conditions
- Cerebral Palsy (CP)
- Being tested
- whole body vibration, designed physiotherapy program
- Keywords
- Cerebral palsy, Fascicle length, Hemiplegia, Range of motion, Whole body vibration
- 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.
whole body vibrationDevice
Also called WBV
On a vibration platform, the children went into a complete squat. The device was calibrated at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 minutes. After the vibration was turned on, the children were told to stay in the squatting position and to report any discomfort that could occur. The vibration automatically shut off after five minutes. The children then rested for a minute. Next, under the identical conditions as for the squatting position, they were instructed to stand on the vibration platform for five minutes with the therapist\'s assistance. Consequently, WBV was applied for a total of 10 minutes during each session.
designed physiotherapy programOther
Also called physical therapy program
structured therapeutic exercise program that included neurodevelopmental approaches, balance exercises, milestone facilitation, stretching exercises, and postural reaction facilitation. The program was conducted for one hour each day, three days a week.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy group | Experimental | Control group: received a designed physical therapy program Receives: Other: designed physiotherapy program |
| whole body vibration group | Experimental | experimental group: received a designed physical therapy program in addition to WBV for 12 weeks Receives: Device: whole body vibration; Other: designed physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee range of motion
Each child in both groups had their knee joint\'s extension angle measured before and after a 12-week therapy program began using an absolute + AxisTM Digital Goniometer
Measured: 12 weeks
Fascicle length of hamstring muscle
The biceps femoris muscle\'s muscle fascicle length was measured at a frequency of 7.5 MHz using GE LOGIQ P6 ultrasonography equipment
Measured: 12 weeks
gross motor function
Gross Motor Functional Measurement-88 : is a common principle-test designed to assess changes in function in various milestones for children with cerebral palsy 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 posted19 Sep 2024
- Study start22 Jul 2023
- Primary completion2 Aug 2023
- Study completion10 Nov 2023
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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600984
- Sponsor's protocol ID
- P.T.REC/012/004996
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Whole Body Vibration on Fascicle Length and Joint Angle in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06600984
- Acronym / sponsor ID
- P.T.REC/012/004996
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral palsy, Fascicle length, Hemiplegia, Range of motion, Whole body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 19 Sep 2024 (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 investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy
Detailed description
to study the effect of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy group | Experimental | Other: designed physiotherapy programControl group: received a designed physical therapy program |
| whole body vibration group | Experimental | Device: whole body vibration, Other: designed physiotherapy programexperimental group: received a designed physical therapy program in addition to WBV for 12 weeks |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages varied from four to six years of both sex
- hemiplegic CP children, were suffering from knee joint flexion deformity due to hamstring muscles tightness
- Level I and II motor function, according to the Growth Motor Function Classification System (GMFC) expanded and revised
- Degree of spasticity ranged from 1 to 2 according to modified Ashworth scale
- All children received neuro-developmental techniques
Key exclusion criteria (6 listed)
- Other causes of knee flexion deformities
- Previous history of orthopedic surgery in knee joint
- Visual or auditory problems
- Seizures
- Sensory or perceptual deficits
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 |
|---|---|---|
| whole body vibrationAlso: WBVOn a vibration platform, the children went into a complete squat. The device was calibrated at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 minutes. After the vibration was turned on, the children were told to stay in the squatting position and to report any discomfort that could occur. The vibration automatically shut off after five minutes. The children then rested for a minute. Next, under the identical conditions as for the squatting position, they were instructed to stand on the vibration platform for five minutes with the therapist\'s assistance. Consequently, WBV was applied for a total of 10 minutes during each session. | Device | whole body vibration group |
| designed physiotherapy programAlso: physical therapy programstructured therapeutic exercise program that included neurodevelopmental approaches, balance exercises, milestone facilitation, stretching exercises, and postural reaction facilitation. The program was conducted for one hour each day, three days a week. | Other | physical therapy group, whole body vibration group |
Primary outcome
Knee range of motion
Time frame: 12 weeks
Each child in both groups had their knee joint\'s extension angle measured before and after a 12-week therapy program began using an absolute + AxisTM Digital Goniometer
Fascicle length of hamstring muscle
Time frame: 12 weeks
The biceps femoris muscle\'s muscle fascicle length was measured at a frequency of 7.5 MHz using GE LOGIQ P6 ultrasonography equipment
gross motor function
Time frame: 12 weeks
Gross Motor Functional Measurement-88 : is a common principle-test designed to assess changes in function in various milestones for children with cerebral palsy 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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and designed physiotherapy program 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 5 inclusion and 6 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 19 Sep 2024. 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?
Knee range of motion (time frame: 12 weeks). The study lists 3 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 19 Sep 2024.