Down SyndromeNCT06036069
Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome
A study testing Conventional physical therapy in people with Down Syndrome, run by Ragaee Saeed Mahmoud at 1 site in Egypt.
Trial summary
Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 20 Jan 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 10 to 16 years.
- Able to recognize commands given to them.
- Understand our verbal command and encouragement.
- Stand and walk independently without repeated falling.
Who cannot join
- Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).
- Musculoskeletal, or mobility disorders.
- Cardiac anomalies.
- Vision or hearing loss.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ragaee Saeed Mahmoud
Giza, Faisal
Ragaee Mahmoud, 00201223611112, ragaeesaeedpt10@gmail.com
Reham Mahmoud, 00201015447798, rsm_211pt@yahoo.com
About this study
Official title: Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children
Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children
Read the detailed description
Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise
- Conditions
- Down Syndrome
- Being tested
- Conventional physical therapy
- Keywords
- Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Also called Physical therapy program
- Standing with feet together while the therapist was sitting behind and manually locking the child knees.
- Step standing with the therapist behind the child.
- High step standing and trying to keep balanced. The child stood on exercise mattress.
- Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress.
- Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction.
- Standing with manual locking of the knees.
- Changing position.
- Gait training.
- Static and dynamic muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy group | Experimental | It consisted of 20 children received conventional physical therapy Receives: Other: Conventional physical therapy |
| Core stability exercises group | Experimental | It consisted of 20 children received conventional physical therapy and core stability exercises Receives: Other: Conventional physical therapy |
| Whole body vibration | Experimental | It consisted of 20 children received conventional physical therapy and whole body vibration exercises Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System
it is a reliable and objective assessment in order to quantify dynamic balance
Measured: before intervention and after 12 weeks of intervention
Secondary outcomes (1)
Hand-held dynamometer
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
Measured: before intervention and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
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
- Model description
- Randomized control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ragaee Saeed Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ragaee Saeed Mahmoud, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036069
- Sponsor's protocol ID
- P.T.REC/012/004335
- Status last verified
- Oct 2023
- First submitted
- 2 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children
- ClinicalTrials.gov ID
- NCT06036069
- Acronym / sponsor ID
- P.T.REC/012/004335
- Conditions
- Down Syndrome
- Keywords
- Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ragaee Saeed MahmoudUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 13 Sep 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.
Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children
Detailed description
Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized control study
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy group | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy |
| Core stability exercises group | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy and core stability exercises |
| Whole body vibration | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy and whole body vibration exercises |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 10 to 16 years.
- Able to recognize commands given to them.
- Understand our verbal command and encouragement.
- Stand and walk independently without repeated falling.
Key exclusion criteria (4 listed)
- Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).
- Musculoskeletal, or mobility disorders.
- Cardiac anomalies.
- Vision or hearing loss.
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 |
|---|---|---|
| Conventional physical therapyAlso: Physical therapy program* Standing with feet together while the therapist was sitting behind and manually locking the child knees. * Step standing with the therapist behind the child. * High step standing and trying to keep balanced. The child stood on exercise mattress. * Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress. * Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction. * Standing with manual locking of the knees. * Changing position. * Gait training. * Static and dynamic muscle contraction. | Other | Conventional physical therapy group, Core stability exercises group, Whole body vibration |
Primary outcome
Biodex Balance System
Time frame: before intervention and after 12 weeks of intervention
it is a reliable and objective assessment in order to quantify dynamic balance
1 secondary outcome
Hand-held dynamometer
Time frame: before intervention and after 12 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Yes
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy in people with Down Syndrome, run by Ragaee Saeed Mahmoud 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 4 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 13 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Balance System (time frame: before intervention and after 12 weeks of intervention). 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 13 Oct 2023.