Physical TherapyNCT05896111
Whole Body Vibration for Hemiparetic Cerebral Palsy
A study testing Physical therapy exercises. in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Physical therapy exercises.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Dec 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children will be included if they have the following:
- Children diagnosed as hemiparetic cerebral palsy.
- Children of both sexes in the age group ranging from 3 to 6 years.
- Spasticity will be grade 1 and 1+ according to modified Ashworth scale.
- They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS).
- Children could understand and follow commands given by the therapist.
Who cannot join
- Children will be excluded if they have any of the following:
- History of convulsions and epilepsy.
- Children with impaired cognitive function.
- Any surgical procedure for correction of deformity or soft tissue release in the past one year.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ministry of Health
Giza
Haytham Ahmed, M.Sc., 0453146570
About this study
Official title: Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy
This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.
Read the detailed description
Studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with Parkinson's disease and multiple sclerosis. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy.
Few Studies Have Shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. Strength of muscles increase as measured by hand held dynamometer. Motor function increase as measured by Gross Motor Function Measure and Gross Motor Function Classification Scale. Increase of the activation and the co- activation of biceps and triceps. Vibrations increase bone mass and muscle strength in upper limbs.
Vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. Reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. Focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles.
So in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.
- Conditions
- Physical Therapy
- Being tested
- Physical therapy exercises.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy exercises.Procedure or surgery
Exercises to treat hemiparetic cerebral palsy
| Study group | Role | What they receive |
|---|---|---|
| designed physiotherapy program | Experimental | These exercises included:
Passive stretching exercises for elbow and wrist flexors. Weight-bearing exercises for the upper limbs. Stimulation of the protective reactions of the upper limbs in all directions. Strengthening exercises for antagonists of the spastic muscles, including elbow and wrist extensors, using different toys and motivation to encourage the children to perform the desired exercises (El-shamy, 2018).
The treatment session for 1hour 5 days / week for 4 weeks. Receives: Procedure: Physical therapy exercises. |
| Whole body vibration. | Experimental | Each child will be seated on an armless chair in front of the platform and instructed to flex both shoulders at 90°, slightly bend both elbows, and then bend the trunk forward to allow both hands to be placed on the platform. Each subject will be allowed to hold the palms slightly off the platform to minimize discomfort and prevent strong stimulation of the organs, eyes, and head. Receives: Procedure: Physical therapy exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder joint abduction range of motion.
Measurement of range of motion of shoulder joint abduction using the digital Goniometer.
Measured: Change from Baseline shoulder joint abduction range of motion at one month.
Change in shoulder joint flexion range of motion.
Measurement of range of motion of shoulder joint flexion using the digital Goniometer.
Measured: Change from Baseline shoulder joint flexion range of motion at one month.
Change in elbow joint flexion range of motion.
Measurement of range of motion of elbow joint flexion using the digital Goniometer.
Measured: Change from Baseline elbow joint flexion range of motion at one month.
Change in elbow joint extension range of motion.
Measurement of range of motion of elbow joint extension using the digital Goniometer.
Measured: Change from Baseline elbow joint extension range of motion at one month.
Change in wrist joint extension range of motion.
Measurement of range of motion of wrist joint extension using the digital Goniometer.
Measured: Change from Baseline wrist joint extension range of motion at one month.
Change in wrist joint flexion range of motion.
Measurement of range of motion of wrist joint flexion using the digital Goniometer.
Measured: Change from Baseline wrist joint flexion range of motion at one month.
Change in strength of shoulder abductors muscles.
Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of shoulder abductors muscles at one month.
Change in strength of shoulder flexors muscles.
Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of shoulder flexors muscles at one month.
Change in strength of elbow flexors muscles.
Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of elbow flexors muscles at one month.
Change in strength of elbow extensors muscles.
Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of elbow extensors muscles at one month.
Change in strength of wrist extensors muscles.
Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of wrist extensors muscles at one month.
Change in strength of wrist flexors muscles.
Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer
Measured: Change from Baseline strength of wrist flexors muscles at one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies 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
- pilot testing to get sample.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haytham Ibrahim Morsi, Cairo University
- Investigators
- Haytham Morsi, M.Sc., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896111
- Sponsor's protocol ID
- P.T.1993
- Status last verified
- Jun 2023
- First submitted
- 27 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration on Upper Limb Range of Motion and Strength in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05896111
- Acronym / sponsor ID
- P.T.1993
- Conditions
- Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jun 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.
This study is to investigate the effect of whole body vibration in children with hemiparetic cerebral palsy on range of motion of shoulder, elbow and wrist and muscle strength of shoulder abductors and flexors, elbow flexors and extensors, wrist extensors and flexors.
Detailed description
Studies show efficacy of whole body vibration in reducing spasticity, improving strength, balance, ankle dorsiflexion angle and gait parameters in post stroke and spinal cord injury patients improving posture and balance in patients with Parkinson's disease and multiple sclerosis. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy.
Few Studies Have Shown improvement in children with cerebral palsy: spasticity decrease as measured by isokinetic dynamometer. Strength of muscles increase as measured by hand held dynamometer. Motor function increase as measured by Gross Motor Function Measure and Gross Motor Function Classification Scale. Increase of the activation and the co- activation of biceps and triceps. Vibrations increase bone mass and muscle strength in upper limbs.
Vibration therapy decreases spasticity and improve motor performance in children with cerebral palsy. Reduce flexors spasticity and improve functions in the rehabilitation of upper limb spasticity. Focal muscle vibration on triceps brachii muscle can reduce the spasticity for both elbow and wrist joint muscles.
So in this study, the investigators are trying to implement an additional rehabilitation method for upper limbs in hemiparetic children to improve their upper limb range of motion and strength which will reflect an improvement in their upper limb functions and activities of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot testing to get sample.
| Arm | Type | Receives |
|---|---|---|
| designed physiotherapy program | Experimental | Procedure: Physical therapy exercises.These exercises included: Passive stretching exercises for elbow and wrist flexors. Weight-bearing exercises for the upper limbs. Stimulation of the protective reactions of the upper limbs in all directions. Strengthening exercises for antagonists of the spastic muscles, including elbow and wrist extensors, using different toys and motivation to encourage the children to perform the desired exercises (El-shamy, 2018). The treatment session for 1hour 5 days / week for 4 weeks. |
| Whole body vibration. | Experimental | Procedure: Physical therapy exercises.Each child will be seated on an armless chair in front of the platform and instructed to flex both shoulders at 90°, slightly bend both elbows, and then bend the trunk forward to allow both hands to be placed on the platform. Each subject will be allowed to hold the palms slightly off the platform to minimize discomfort and prevent strong stimulation of the organs, eyes, and head. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children diagnosed as hemiparetic cerebral palsy.
- Children of both sexes in the age group ranging from 3 to 6 years.
- Spasticity will be grade 1 and 1+ according to modified Ashworth scale.
- They will be selected with Level I and II according to Gross Motor Function Classification (GMFCS).
- Children could understand and follow commands given by the therapist.
Key exclusion criteria (4 listed)
- History of convulsions and epilepsy.
- Children with impaired cognitive function.
- Any surgical procedure for correction of deformity or soft tissue release in the past one year.
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 exercises.Exercises to treat hemiparetic cerebral palsy | Procedure or surgery | Whole body vibration., designed physiotherapy program |
Primary outcome
Change in shoulder joint abduction range of motion.
Time frame: Change from Baseline shoulder joint abduction range of motion at one month.
Measurement of range of motion of shoulder joint abduction using the digital Goniometer.
Change in shoulder joint flexion range of motion.
Time frame: Change from Baseline shoulder joint flexion range of motion at one month.
Measurement of range of motion of shoulder joint flexion using the digital Goniometer.
Change in elbow joint flexion range of motion.
Time frame: Change from Baseline elbow joint flexion range of motion at one month.
Measurement of range of motion of elbow joint flexion using the digital Goniometer.
Change in elbow joint extension range of motion.
Time frame: Change from Baseline elbow joint extension range of motion at one month.
Measurement of range of motion of elbow joint extension using the digital Goniometer.
Change in wrist joint extension range of motion.
Time frame: Change from Baseline wrist joint extension range of motion at one month.
Measurement of range of motion of wrist joint extension using the digital Goniometer.
Change in wrist joint flexion range of motion.
Time frame: Change from Baseline wrist joint flexion range of motion at one month.
Measurement of range of motion of wrist joint flexion using the digital Goniometer.
Change in strength of shoulder abductors muscles.
Time frame: Change from Baseline strength of shoulder abductors muscles at one month.
Measurement of strength of shoulder abductors muscles using the Lafayette handheld dynamometer
Change in strength of shoulder flexors muscles.
Time frame: Change from Baseline strength of shoulder flexors muscles at one month.
Measurement of strength of shoulder flexors muscles using the Lafayette handheld dynamometer
Change in strength of elbow flexors muscles.
Time frame: Change from Baseline strength of elbow flexors muscles at one month.
Measurement of strength of elbow flexors muscles using the Lafayette handheld dynamometer
Change in strength of elbow extensors muscles.
Time frame: Change from Baseline strength of elbow extensors muscles at one month.
Measurement of strength of elbow extensors muscles using the Lafayette handheld dynamometer
Change in strength of wrist extensors muscles.
Time frame: Change from Baseline strength of wrist extensors muscles at one month.
Measurement of strength of wrist extensors muscles using the Lafayette handheld dynamometer
Change in strength of wrist flexors muscles.
Time frame: Change from Baseline strength of wrist flexors muscles at one month.
Measurement of strength of wrist flexors muscles using the Lafayette handheld dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- 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.
Haytham Morsi, M.Sc. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy exercises. in people with Physical Therapy, 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 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Adel, B.Sc. (01554552868, 10722020440502@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shoulder joint abduction range of motion. (time frame: Change from Baseline shoulder joint abduction range of motion at one month.). The study lists 12 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 9 Jun 2023.