Cerebral PalsyNCT05782413
Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
A study testing mechanical vestibular stimulation and The design exercise program in people with Cerebral Palsy, run by Ahmed Mohamed Abd El Haleem Ghoniem at 1 site in Egypt.
Trial summary
The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- mechanical vestibular stimulation and The design exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2023to 31 Mar 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children will be included in the study if they fulfil the following criteria:
- Diagnosed with hemiparetic cerebral palsy.
- Age ranged from 4 to 6 years.
- Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale
- Both genders will be included.
- The child will be able to follow verbal commands and instructions.
Who cannot join
- Children will be excluded from the study if:
- Any congenital or developmental disorders in addition to hemiplegia cerebral palsy.
- Current hospitalization for urgent medical reasons.
- Severe mental retardation.
- Children having visual or auditory defects.
- Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to the wrist and hand.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mechanical Vestibular Stimulation On Hand Function In Children With Hemiparetic Cerebral Palsy
The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for reaching, grasping, releasing, and manipulating objects is often compromised
- Conditions
- Cerebral Palsy
- Being tested
- mechanical vestibular stimulation, The design exercise program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical vestibular stimulationOther
Device produces mechanical vestibular stimulation. The child was placed in a sitting position on the swing and his hands grasping the ropes at the sides then the therapist stood behind him and begin pushing the platform in fast and jerky movements in back and front, side to side, and in spinning directions with the child trying to maintain his balance in all different directions.
The design exercise programOther
A selected therapeutic exercises program was based on the principles of NDTBobath neurodevelopmental therapy, which is effective in controlling spasticity in children with cerebral palsy and improving motor function.
- Preparation of structures and mobilizations of the scapula, shoulder joint, and chest according to the NDT-Bobath concept ii. Exercises to increase shoulder mobility and elbow joint extension. iii. Fine motor skill exercises, wrist, and hand
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy. Receives: Other: The design exercise program |
| Group B | Experimental | The child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins. Receives: Other: mechanical vestibular stimulation; Other: The design exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
fine motor skills
We will use Peabody Developmental Motor Scale (PDMS-2) to measure visual motor integration, grasp and fine motor.
Measured: 3 month
pinch strength
We will use Hand Dynamometer to measure pinch strength.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start3 Dec 2023
- Primary completion21 Mar 2024
- Study completion31 Mar 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Abd El Haleem Ghoniem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Abd El Haleem Ghoniem, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782413
- Sponsor's protocol ID
- EG, KFS lab 2 Research
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2023
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Vestibular Stimulation On Hand Function In Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05782413
- Acronym / sponsor ID
- EG, KFS lab 2 Research
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahmed Mohamed Abd El Haleem GhoniemUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 23 Mar 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.
The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for reaching, grasping, releasing, and manipulating objects is often compromised
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: The design exercise programThe child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy. |
| Group B | Experimental | Other: mechanical vestibular stimulation, Other: The design exercise programThe child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children will be included in the study if they fulfil the following criteria:
Key exclusion criteria (6 listed)
- Children will be excluded from the study if:
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 |
|---|---|---|
| mechanical vestibular stimulationDevice produces mechanical vestibular stimulation. The child was placed in a sitting position on the swing and his hands grasping the ropes at the sides then the therapist stood behind him and begin pushing the platform in fast and jerky movements in back and front, side to side, and in spinning directions with the child trying to maintain his balance in all different directions. | Other | Group B |
| The design exercise programA selected therapeutic exercises program was based on the principles of NDTBobath neurodevelopmental therapy, which is effective in controlling spasticity in children with cerebral palsy and improving motor function. i. Preparation of structures and mobilizations of the scapula, shoulder joint, and chest according to the NDT-Bobath concept ii. Exercises to increase shoulder mobility and elbow joint extension. iii. Fine motor skill exercises, wrist, and hand | Other | Group A, Group B |
Primary outcome
fine motor skills
Time frame: 3 month
We will use Peabody Developmental Motor Scale (PDMS-2) to measure visual motor integration, grasp and fine motor.
pinch strength
Time frame: 3 month
We will use Hand Dynamometer to measure pinch strength.
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 30 Apr 2024.
- 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.
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 mechanical vestibular stimulation and The design exercise program in people with Cerebral Palsy, run by Ahmed Mohamed Abd El Haleem Ghoniem 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 6 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 30 Apr 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?
fine motor skills (time frame: 3 month). 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 30 Apr 2024.