Down SyndromeNCT05769556
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
A study testing Brain Gym Exercises and Traditional physiotherapy in people with Down Syndrome, run by Aliaa Altohamy Goda at 1 site in Egypt.
Trial summary
This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome . Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Brain Gym Exercises and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 28 Nov 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
- Child characteristics:
- Their age ranged from six to twelve years.
- Both genders will be included.
- ALL children were mentally sub-normal and they were able to understand the command that will give to them (IQ ranged from 60 - 70) according to the national research centre reports.
- Their weight and height will be within normal ranges.
- They were able to stand on the balance check system and maintain stability on it.
Who cannot join
- hildren with DS, who might have one or more of the following will be excluded:
- Children with severe mental retardation.
- Children who have any associated disorders or any congenital abnormalities that may affect balance.
- Children with visual defects that can affect their performance.
- Obese children.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome .
Read the detailed description
Evaluation procedures:
History of the patients was carefully taken to collect data about their general conditions, physical activity and current medication. The procedures of this study were divided in the following main parts:
-Preparatory Procedures:
- All medical and demographic data of subjects will be collected
- The role of physical therapy importance in improving their life will be explained.
- The basic vital signs of all patients will be monitored (BP, temperature, respiratory rate, and HR).
- The patients will be instructed to report any side effects during the treatment sessions . explained to the children and to their parents, before conducting the study. All the participants were screened (examined) according to inclusion and exclusion criteria. then met the parents of the participants, told them about the study, and received a written approval from them .
All the children were firstly screened for balance deficit (static , dynamic and functional balance) by using
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
- Paediatric Balance Scale (PBS) for functional balance assessment
- the assessment and the treatment program, were conducted for each child individually, before and after the treatment period. assessment :
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
- Paediatric Balance Scale (PBS) for functional balance assessment
TTT :
Group A will receive brain gym exercises and physiotherapy, while Group (B) will receive physiotherapy alone.
brain gym exercises will be applied for 12 weeks , 3 per week .
Therapist Will ask the child to drink a cup of water ,then investigators apply these exercises :
Cross Crawl - Elephant - Belly breathing -The owl - Arm activation -positive points - Energizer - foot flex - neck rolls -the grounder -Brain Buttons -Hook Up Sitting position - Thinking Caps- Lazy Eights - The Rocker-Calf pump - The gravity glider exercise.
- Conditions
- Down Syndrome
- Being tested
- Brain Gym Exercises, Traditional physiotherapy
- Keywords
- Brain Gym Exercises, Postural Stability
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Gym ExercisesOther
Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.
Traditional physiotherapyOther
A Group of exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | will receive brain gym exercises and physiotherapy . Receives: Other: Brain Gym Exercises |
| Group (B) | Active comparator | will receive physiotherapy alone. Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
we will use
- Single leg stance TEST (SLS)
- Timed up and Go Test ( TUG)
- Paediatric Balance Scale (PBS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 May 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aliaa Altohamy Goda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aliaa Altohamy Goda, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769556
- Sponsor's protocol ID
- EG, KFS lab Research7
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05769556
- Acronym / sponsor ID
- EG, KFS lab Research7
- Conditions
- Down Syndrome
- Keywords
- Brain Gym Exercises, Postural Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aliaa Altohamy GodaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 15 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.
This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome .
Detailed description
Evaluation procedures:
History of the patients was carefully taken to collect data about their general conditions, physical activity and current medication. The procedures of this study were divided in the following main parts:
-Preparatory Procedures:
- All medical and demographic data of subjects will be collected
- The role of physical therapy importance in improving their life will be explained.
- The basic vital signs of all patients will be monitored (BP, temperature, respiratory rate, and HR).
- The patients will be instructed to report any side effects during the treatment sessions . explained to the children and to their parents, before conducting the study. All the participants were screened (examined) according to inclusion and exclusion criteria. then met the parents of the participants, told them about the study, and received a written approval from them .
All the children were firstly screened for balance deficit (static , dynamic and functional balance) by using
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
- Paediatric Balance Scale (PBS) for functional balance assessment
- the assessment and the treatment program, were conducted for each child individually, before and after the treatment period. assessment :
- Single leg stance Test (SLS) for static balance assessment
- Timed up and Go Test (TUG) for dynamic balance assessment
- Paediatric Balance Scale (PBS) for functional balance assessment
TTT :
Group A will receive brain gym exercises and physiotherapy, while Group (B) will receive physiotherapy alone.
brain gym exercises will be applied for 12 weeks , 3 per week .
Therapist Will ask the child to drink a cup of water ,then investigators apply these exercises :
Cross Crawl - Elephant - Belly breathing -The owl - Arm activation -positive points - Energizer - foot flex - neck rolls -the grounder -Brain Buttons -Hook Up Sitting position - Thinking Caps- Lazy Eights - The Rocker-Calf pump - The gravity glider exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Brain Gym Exerciseswill receive brain gym exercises and physiotherapy . |
| Group (B) | Active comparator | Other: Traditional physiotherapywill receive physiotherapy alone. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- -
- Their age ranged from six to twelve years.
- Both genders will be included.
- ALL children were mentally sub-normal and they were able to understand the command that will give to them (IQ ranged from 60 - 70) according to the national research centre reports.
- Their weight and height will be within normal ranges.
Key exclusion criteria (5 listed)
- Children with severe mental retardation.
- Children who have any associated disorders or any congenital abnormalities that may affect balance.
- Children with visual defects that can affect their performance.
- Obese children.
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 |
|---|---|---|
| Brain Gym ExercisesBrain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically. | Other | Group A |
| Traditional physiotherapyA Group of exercises | Other | Group (B) |
Primary outcome
Postural Stability
Time frame: 3 months
we will use * Single leg stance TEST (SLS) * Timed up and Go Test ( TUG) * Paediatric Balance Scale (PBS)
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 12 Mar 2024.
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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 Brain Gym Exercises and Traditional physiotherapy in people with Down Syndrome, run by Aliaa Altohamy Goda 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 7 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: finished, as of the sponsor's last update on 12 Mar 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?
Postural Stability (time frame: 3 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 12 Mar 2024.