Diplegic Cerebral PalsyNCT05692336
a Comparison Between the Effectiveness of Vestibular and Dual Task on Balance in Diplegic Children
A study testing vestibular training and dual task training in people with Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
the study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- vestibular training and dual task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 30 Apr 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of diplegic cerebral palsy .
- age range : from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
Who cannot join
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza
amira A mahmoud, +201015039297, ashrafamira74@gmail.com
About this study
Official title: a Comparison Between the Effectiveness of Vestibular Versus Dual Task Training on Balance in Children With Diplegic Cerebral Palsy
the study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy.
so in this study the sample will be divided into two equal groups, each group will recieve only one type of training ( vestibular training or dual task training ) the balance of the diplegic children will be assessed before and after using HUMAC balance system and pediatric balance scale , the results will be compared between both groups and if there is one training is more effective than the other , it will be recommended most in the future treatment program.
Read the detailed description
A comparative experimental design was used. Children participating in this study were assigned into two equal groups, Thirty four children with diplegic Cerebral Palsy of both genders who have balance problems were selected to join this study with the following criteria:
- all the children diagnosed as diplegic cerebral palsy.
- Their age are range from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
And Children were excluded in the presence of the following:
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months.. all the children will be assigned in one of two groups ( vestibular training group and dual task group ) the training will be continue for definite period of time , and the balance abilities for the children in each group will be assessed before and after the treatment completely ended and the result will be compared to conclude which group benefit more and have a greater balance improvement and the treatment that causes a greater improvement will be more recommended in the future physical therapy plan for treatment of diplegic cerebral palsied children. the balance is assessed using HUMAC balance system and pediatric balance scale .
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- vestibular training, dual task training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular trainingOther
balance training in the form of vestibular training
dual task trainingOther
balance training in the form of dual task training
| Study group | Role | What they receive |
|---|---|---|
| vestibular training | Experimental | balance training that focus on vestibular system stimulation like when the eyes are folded while standing on a balance board or walking on swinging boards Receives: Other: vestibular training |
| dual task training | Experimental | The children received special balance training in the form of dual-task training performing balance activities as a basic task in conjunction with second task that includes upper limb activity using basketball and long rings shaft or cognitive task like telling a story during balance training . Receives: Other: dual task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
static balance will be assessed using HUMAC balance system , a comparison of the results between two groups will be carried out , and the more effective treatment program will be more recommended than the other
Measured: 2 months of training
dynamic balance
dynamic balance will be assessed using pediatric balance scale and a comparison between the results of the two groups will be done to recommend one over the other.
Measured: 2 months of training
which training will be more beneficial for the diplegic child balance
after the results of both groups (for static and dynamic balance) are analyzed one treatment will be recommended most (the treatment for the group that has greater balance improvement ).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start20 Feb 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic 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
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ashraf Mahmoud Mohamed, Cairo University
- Investigators
- amira A mahmoud, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692336
- Sponsor's protocol ID
- P.T.REC/012/003716
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 20 Jan 2023
- 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Comparison Between the Effectiveness of Vestibular Versus Dual Task Training on Balance in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05692336
- Acronym / sponsor ID
- P.T.REC/012/003716
- Conditions
- Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 20 Jan 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 study is carried out to identify If there is any difference between the effectiveness of Vestibular training and Dual task training on balance in children with Diplegic Cerebral Palsy.
so in this study the sample will be divided into two equal groups, each group will recieve only one type of training ( vestibular training or dual task training ) the balance of the diplegic children will be assessed before and after using HUMAC balance system and pediatric balance scale , the results will be compared between both groups and if there is one training is more effective than the other , it will be recommended most in the future treatment program.
Detailed description
A comparative experimental design was used. Children participating in this study were assigned into two equal groups, Thirty four children with diplegic Cerebral Palsy of both genders who have balance problems were selected to join this study with the following criteria:
- all the children diagnosed as diplegic cerebral palsy.
- Their age are range from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
And Children were excluded in the presence of the following:
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months.. all the children will be assigned in one of two groups ( vestibular training group and dual task group ) the training will be continue for definite period of time , and the balance abilities for the children in each group will be assessed before and after the treatment completely ended and the result will be compared to conclude which group benefit more and have a greater balance improvement and the treatment that causes a greater improvement will be more recommended in the future physical therapy plan for treatment of diplegic cerebral palsied children. the balance is assessed using HUMAC balance system and pediatric balance scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vestibular training | Experimental | Other: vestibular trainingbalance training that focus on vestibular system stimulation like when the eyes are folded while standing on a balance board or walking on swinging boards |
| dual task training | Experimental | Other: dual task trainingThe children received special balance training in the form of dual-task training performing balance activities as a basic task in conjunction with second task that includes upper limb activity using basketball and long rings shaft or cognitive task like telling a story during balance training . |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- clinical diagnosis of diplegic cerebral palsy .
- age range : from 5 to 10 years old.
- The degree of spasticity is between grade 1 or 1+ according to Modified Ashworth Scale (Charalambous ,2013).
- They are at level I OR II on Gross Motor Function Classification System .
- All the children were able to follow verbal command and instructions.
Key exclusion criteria (5 listed)
- Children that suffer from epilepsy.
- Severe visual and auditory problems.
- Structural or fixed soft tissue deformities of Lower extremities.
- Severe mental retardation.
- Botox injection in the lower extremity in the past 6 months
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 |
|---|---|---|
| vestibular trainingbalance training in the form of vestibular training | Other | vestibular training |
| dual task trainingbalance training in the form of dual task training | Other | dual task training |
Primary outcome
Static Balance
Time frame: 2 months of training
static balance will be assessed using HUMAC balance system , a comparison of the results between two groups will be carried out , and the more effective treatment program will be more recommended than the other
dynamic balance
Time frame: 2 months of training
dynamic balance will be assessed using pediatric balance scale and a comparison between the results of the two groups will be done to recommend one over the other.
which training will be more beneficial for the diplegic child balance
Time frame: 2 months
after the results of both groups (for static and dynamic balance) are analyzed one treatment will be recommended most (the treatment for the group that has greater balance improvement ).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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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.
amira A mahmoud principal investigator
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 vestibular training and dual task training in people with Diplegic 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 5 inclusion and 5 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 20 Jan 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 amira A mahmoud, bachelor (+201015039297, ashrafamira74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: 2 months of training). 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 20 Jan 2023.