Cerebral PalsyNCT07096089
Effect of Vibration on Shoulder Proximal Stability in Children With Cerebral Palsy
A study testing Conventional physical therapy program and Sling exercise therapy and Whole body vibration in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Objectives: Children with cerebral palsy have weak proximal stability which not only affects range of available motion but also reflects on distal dexterity. These have a great impact on their mobility and efficiency of daily living activities. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Conventional physical therapy program and Sling exercise therapy and Whole body vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 10 Apr 2024
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cerebral palsy affecting weight bearing of the upper limbs.
- Aged from 4 to 9 years.
- Both gender participated.
- Having grade 1 and 1+ spasticity according to the Modified Ashworth Scale.
Who cannot join
- Congenital anomalies.
- Surgical or neurological disease of the upper limbs.
- Osteopenia or osteoporosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical therapy, Cairo University
Giza, Office Post Cairo University Giza, 12613
About this study
Official title: Effect of Whole-body Vibration on Shoulder Proximal Stability in Children With Cerebral Palsy
Objectives: Children with cerebral palsy have weak proximal stability which not only affects range of available motion but also reflects on distal dexterity. These have a great impact on their mobility and efficiency of daily living activities. Vibration has been regarded as an effective exercise method to improve muscle strength and endurance. The aim of this study was to determine the effect of vibration on shoulder proximal stability in children with cerebral palsy.
Methods: Fifty children with cerebral palsy from 4 to 9 years old participated in this study and were selected from the outpatient clinic of faculty of physical therapy. They were divided into two groups of equal sizes randomly. The control group received a conventional physical therapy program in addition to Sling exercise therapy, and the study group received the same conventional physical therapy program in addition to Sling exercise therapy (SET) and Whole-body vibration (WBV). Shoulder muscle strength was assessed for both groups by using Lafayette manual muscle tester before and after treatment.
- Conditions
- Cerebral Palsy
- Being tested
- Conventional physical therapy program and Sling exercise therapy, Whole body vibration
- Keywords
- Cerebral palsy, Proximal stability, Shoulder, Whole body vibration
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy program and Sling exercise therapyProcedure or surgery
The control group received a conventional physical therapy program in addition to sling exercise therapy (SET) for 60 minutes.
Whole body vibrationProcedure or surgery
The study group received the same selected conventional physical therapy program in addition to sling exercise therapy (SET) given to the control group (for 30 minutes) besides whole body vibration (WBV) (for 30 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy program and Sling exercise therapy | Experimental | Conventional physical therapy program and Sling exercise therapy Receives: Procedure: Conventional physical therapy program and Sling exercise therapy |
| Whole body vibration | Experimental | Whole body vibration Receives: Procedure: Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder muscle strength
Lafayette manual muscle tester In order to produce precise, objective, and dependable findings, the Lafayette Manual Muscle Tester (MMT) Model Number 01163 blends modern ergonomic design with accuracy and precision. The three cushioned stirrups that were interchangeable allowed for the confident and efficient use of recognized techniques while maintaining patient comfort.
No other manual muscle test method uses the advancements found in the Lafayette MMT. The user may choose from an extensive array of variables through the interactive menus, including high and low threshold settings (to account for larger muscles or fingers), test periods ranging from one to ten seconds, and data storage. There is less chance of reading mistakes or selecting undesirable alternatives because of the wide, easy-to-read LCD screen that clearly shows all the information.
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start10 Oct 2023
- Primary completion10 Jan 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Experimental trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Usama Mahmoud Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096089
- Sponsor's protocol ID
- P.T.REC/012/004848
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration on Shoulder Proximal Stability in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07096089
- Acronym / sponsor ID
- P.T.REC/012/004848
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Proximal stability, Shoulder, Whole body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 31 Jul 2025 (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.
Objectives: Children with cerebral palsy have weak proximal stability which not only affects range of available motion but also reflects on distal dexterity. These have a great impact on their mobility and efficiency of daily living activities. Vibration has been regarded as an effective exercise method to improve muscle strength and endurance. The aim of this study was to determine the effect of vibration on shoulder proximal stability in children with cerebral palsy.
Methods: Fifty children with cerebral palsy from 4 to 9 years old participated in this study and were selected from the outpatient clinic of faculty of physical therapy. They were divided into two groups of equal sizes randomly. The control group received a conventional physical therapy program in addition to Sling exercise therapy, and the study group received the same conventional physical therapy program in addition to Sling exercise therapy (SET) and Whole-body vibration (WBV). Shoulder muscle strength was assessed for both groups by using Lafayette manual muscle tester before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental trial
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy program and Sling exercise therapy | Experimental | Procedure: Conventional physical therapy program and Sling exercise therapyConventional physical therapy program and Sling exercise therapy |
| Whole body vibration | Experimental | Procedure: Whole body vibrationWhole body vibration |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children with cerebral palsy affecting weight bearing of the upper limbs.
- Aged from 4 to 9 years.
- Both gender participated.
- Having grade 1 and 1+ spasticity according to the Modified Ashworth Scale.
Key exclusion criteria (3 listed)
- Congenital anomalies.
- Surgical or neurological disease of the upper limbs.
- Osteopenia or osteoporosis.
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 |
|---|---|---|
| Conventional physical therapy program and Sling exercise therapyThe control group received a conventional physical therapy program in addition to sling exercise therapy (SET) for 60 minutes. | Procedure or surgery | Conventional physical therapy program and Sling exercise therapy |
| Whole body vibrationThe study group received the same selected conventional physical therapy program in addition to sling exercise therapy (SET) given to the control group (for 30 minutes) besides whole body vibration (WBV) (for 30 minutes). | Procedure or surgery | Whole body vibration |
Primary outcome
Shoulder muscle strength
Time frame: 4 to 6 months
Lafayette manual muscle tester In order to produce precise, objective, and dependable findings, the Lafayette Manual Muscle Tester (MMT) Model Number 01163 blends modern ergonomic design with accuracy and precision. The three cushioned stirrups that were interchangeable allowed for the confident and efficient use of recognized techniques while maintaining patient comfort. No other manual muscle test method uses the advancements found in the Lafayette MMT. The user may choose from an extensive array of variables through the interactive menus, including high and low threshold settings (to account for larger muscles or fingers), test periods ranging from one to ten seconds, and data storage. There is less chance of reading mistakes or selecting undesirable alternatives because of the wide, easy-to-read LCD screen that clearly shows all the information.
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 31 Jul 2025.
- 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 Conventional physical therapy program and Sling exercise therapy and Whole body vibration in people with Cerebral Palsy, 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 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: finished, as of the sponsor's last update on 31 Jul 2025. 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?
Shoulder muscle strength (time frame: 4 to 6 months). 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 31 Jul 2025.