BalanceNCT05928949
Pilates Exercises and Down Syndrome
A study testing pilates exercises in people with Balance and Down Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Balance, Down Syndrome, Pilates Exercises
- What is being tested?
- pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jun 2023to 11 Sep 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion.
Who cannot join
- (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Physical Therapy
Cairo, Giza Governorate
Faculty of physical therapy OP Therapy, 01003727467, alaaalnemr28@gmail.com
About this study
Official title: Effect of Pilates Exercises on Balance and Gross Motor Co-Ordination In Children With Down Syndrome
Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children.
the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome
Read the detailed description
Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes.
Group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attended the intervention program three times/week for 3 months
- Conditions
- Balance, Down Syndrome, Pilates Exercises
- Being tested
- pilates exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilates exercisesOther
Pilates is a system of repetitive exercises performed on a yoga mat or other equipment to promote strength, stability, and flexibility. Pilates exercises develop the body through muscular effort that stems from the core.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes. Receives: Other: pilates exercises |
| pilates exercises | Experimental | group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attend the intervention program three times/week for 3 months Receives: Other: pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
Balance assessment will be performed in both groups before and after the intervention to find any significant difference, by using the Biodex Balance System to evaluate all measurable variables of stability indices (anteroposterior stability index and mediolateral stability index).
Measured: 3 months
Bruininks-oseretsky test of motor proficiency-second version (BOT-2)
BOT-2 measures gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children, who have varying motor control abilities ranging from normal to mild or moderate. In this study, it will be used to measure gross motor co-ordination.
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 posted3 Jul 2023
- Study start26 Jun 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion11 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fahmy Hassan Al Nemr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928949
- Sponsor's protocol ID
- P.T.REC/012/003399
- Status last verified
- Jan 2023
- First submitted
- 25 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Nemr A, Reffat S. Effect of Pilates exercises on balance and gross motor coordination in children with Down syndrome. Acta Neurol Belg. 2024 Oct;124(5):1499-1505. doi: 10.1007/s13760-024-02517-w. Epub 2024 Apr 1.
PubMed 38558387
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Balance and Gross Motor Co-Ordination In Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05928949
- Acronym / sponsor ID
- P.T.REC/012/003399
- Conditions
- Balance, Down Syndrome, Pilates Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 11 Sep 2023 (estimated)
- First posted
- 3 Jul 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.
Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children.
the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome
Detailed description
Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes.
Group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attended the intervention program three times/week for 3 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Other: pilates exercisesGroup A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes. |
| pilates exercises | Experimental | Other: pilates exercisesgroup B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attend the intervention program three times/week for 3 months |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion.
Key exclusion criteria (1 listed)
- (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.
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 |
|---|---|---|
| pilates exercisesPilates is a system of repetitive exercises performed on a yoga mat or other equipment to promote strength, stability, and flexibility. Pilates exercises develop the body through muscular effort that stems from the core. | Other | conventional physical therapy, pilates exercises |
Primary outcome
balance
Time frame: 3 months
Balance assessment will be performed in both groups before and after the intervention to find any significant difference, by using the Biodex Balance System to evaluate all measurable variables of stability indices (anteroposterior stability index and mediolateral stability index).
Bruininks-oseretsky test of motor proficiency-second version (BOT-2)
Time frame: 3 months
BOT-2 measures gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children, who have varying motor control abilities ranging from normal to mild or moderate. In this study, it will be used to measure gross motor co-ordination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 38558387Al-Nemr A, Reffat S. Effect of Pilates exercises on balance and gross motor coordination in children with Down syndrome. Acta Neurol Belg. 2024 Oct;124(5):1499-1505. doi: 10.1007/s13760-024-02517-w. Epub 2024 Apr 1.
- Individual participant dataSharing planned: No
Related trials for Balance
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruiting
Cerebello-Cortical Connectivity and Balance Adaptation in Younger and Older Adults
Aging, Postural Balance
Recruiting
Effects of Contralateral Gravity Eliminated Gluteus Medius and Ipsilateral Quadratus Lumborum Strengthening on Pelvic Alignment, Balance and Functional Mobility on Subacute Stroke Patients
Stroke
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
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 pilates exercises in people with Balance and Down Syndrome, 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 1 inclusion and 1 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 3 Jul 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 Alaa F AL-Nemr, Phd (01003727467, alaaalnemr28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05928949, which also lists 1 linked publication.
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 3 Jul 2023.