Cerebral PalsyNCT05606926
Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
A study testing physical therapy program, whole body vibration (without extra weight vest) and whole body vibration (with weight vest) in people with Cerebral Palsy, run by Cairo University.
Trial summary
Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- physical therapy program, whole body vibration (without extra weight vest) and whole body vibration (with weight vest)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Nov 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will range from 8-12 years, from both sexes.
- Level II and III of gross motor functional classification system
- Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
- Ability to understand and follow simple verbal instruc
Who cannot join
- Uncontrolled epilepsy.
- Mental retardation or autistic features.
- Medication changes that could affect muscle strength or tone
- Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
- Structural or fixed soft tissue deformities of the lower and/or upper extremities.
- Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
- Botox injection in the lower and/or upper extremities in the past 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.
- Conditions
- Cerebral Palsy
- Being tested
- physical therapy program, whole body vibration (without extra weight vest), whole body vibration (with weight vest)
- Keywords
- Cerebral palsy, balance, muscle strength, spastic diplegia, HUMAC balance system
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy programOther
Flexibility exercises to restore joint mobility of soft tissues, Static and dynamic balance exercises, Functional gait training , Functional strengthening exercises will be conducted three times a week, for three consecutive months.
whole body vibration (without extra weight vest)Other
9 minutes of three sets of 3-min semi-squats on the vibration platform. three times a week, for three consecutive months.
whole body vibration (with weight vest)Other
The extra-weight applied in the vest will be calculated as 10% of the child body weight. The vest is designed to allow small bags of sand with different weights that are distributed equally on anterior-posterior and mediolateral plans.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | 15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months. Receives: Other: physical therapy program; Other: whole body vibration (without extra weight vest) |
| Experimental group | Experimental | 15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest. Receives: Other: physical therapy program; Other: whole body vibration (with weight vest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk control
The Trunk Control Measurement Scale is used to assess trunk control and consists of static and dynamic sitting balance in children aged 8 to 15 years with spastic CP
Measured: three months
Gross motor function
The Gross motor function measure-88 will be used to assess motor function in 88 items across five dimensions: (a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. dimensions D and E will be assessed in the current study The assessment of each item will be conducted carefully and scored according to the scale scoring key (scale from 0-3) with total score 100 and higher score represent better performance
Measured: three months
balance
Human computer balance system will be used to assess balance to assess center op pressure and limits of stability
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- HOSAM A ALMOHANDES, B.S.C, Study director, Cairo university, faculty of physical therapyNahla M Ibrahim, Phd, Study chair, Cairo university, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606926
- Sponsor's protocol ID
- whole body vibration
- Status last verified
- Dec 2022
- First submitted
- 27 Sep 2022
- Last updated
- 5 Dec 2022
- 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 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT05606926
- Acronym / sponsor ID
- whole body vibration
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, balance, muscle strength, spastic diplegia, HUMAC balance system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 7 Nov 2022 (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.
Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Other | Other: physical therapy program, Other: whole body vibration (without extra weight vest)15 Children with spastic diplegia in this group will a designed physical therapy program for 60 minutes per session in addition to WBV for 10 minutes, three times a week, for three consecutive months. |
| Experimental group | Experimental | Other: physical therapy program, Other: whole body vibration (with weight vest)15 Children with spastic diplegia in this group will receive the same designed physical therapy program while WBV will be conducted while wearing a weighted vest. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their age will range from 8-12 years, from both sexes.
- Level II and III of gross motor functional classification system
- Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
- Ability to understand and follow simple verbal instruc
Key exclusion criteria (7 listed)
- Uncontrolled epilepsy.
- Mental retardation or autistic features.
- Medication changes that could affect muscle strength or tone
- Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
- Structural or fixed soft tissue deformities of the lower and/or upper extremities.
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 |
|---|---|---|
| physical therapy programFlexibility exercises to restore joint mobility of soft tissues, Static and dynamic balance exercises, Functional gait training , Functional strengthening exercises will be conducted three times a week, for three consecutive months. | Other | Experimental group, Group I |
| whole body vibration (without extra weight vest)9 minutes of three sets of 3-min semi-squats on the vibration platform. three times a week, for three consecutive months. | Other | Group I |
| whole body vibration (with weight vest)The extra-weight applied in the vest will be calculated as 10% of the child body weight. The vest is designed to allow small bags of sand with different weights that are distributed equally on anterior-posterior and mediolateral plans. | Other | Experimental group |
Primary outcome
Trunk control
Time frame: three months
The Trunk Control Measurement Scale is used to assess trunk control and consists of static and dynamic sitting balance in children aged 8 to 15 years with spastic CP
Gross motor function
Time frame: three months
The Gross motor function measure-88 will be used to assess motor function in 88 items across five dimensions: (a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. dimensions D and E will be assessed in the current study The assessment of each item will be conducted carefully and scored according to the scale scoring key (scale from 0-3) with total score 100 and higher score represent better performance
balance
Time frame: three months
Human computer balance system will be used to assess balance to assess center op pressure and limits of stability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
HOSAM A ALMOHANDES, B.S.C study director
Cairo university, faculty of physical therapy
Nahla M Ibrahim, Phd study chair
Cairo university, faculty of physical therapy
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy program, whole body vibration (without extra weight vest) and whole body vibration (with weight vest) in people with Cerebral Palsy, 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 7 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 5 Dec 2022. 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 Amira M Abd-elmonem, PhD (01155553316, Dramira.salim2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk control (time frame: three months). 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 5 Dec 2022.