Down SyndromeNCT05969873
Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
A study testing Pilates exercise and Balance training in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. 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?
- Pilates exercise and Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jul 2023to 15 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
- Down's syndrome children with age between 6 and 12 years.
- The ability to execute required motor skill proficiency and executive function tests.
- The capacity to walk and stand by oneself
Who cannot join
- • Children who are not able to comprehend commands.
- Associated cardiovascular and orthopedic condition.
- Loss of functional hearing and vision or a related respiratory disease.
- History of traumatic injury
- History of previous surgery
- Inability of parents to understand the procedure and their unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Down's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. Pilates activities focus on the concept of control of muscles. Pilates increases trunk flexibility, abdominal and core strength and endurance, and deep core muscle activation hence improving balance and posture.
Read the detailed description
The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy+ Pilates.
- Conditions
- Down Syndrome
- Being tested
- Pilates exercise, Balance training
- Keywords
- Balance, Contrology, Down syndrome, Pilates, Pediatric Balance Scale
- 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 exerciseOther
Also called Experimental group
Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.
Balance trainingOther
Also called Control group
Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | In this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased. Receives: Other: Pilates exercise |
| Balance training group | Active comparator | In this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase. Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in <20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk
Measured: 12 weeks
Secondary outcomes (1)
Timed up and go test
TUG is a simple test used to assess a person's mobility and evaluate both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turns around 180 degrees, walk back to the chair and sit down while turning 180 degrees.
Interpretation: ≤ 10 seconds= normal. A score of ≥ 14 seconds has been shown to indicate high risk of fall.
ICC value for interrater reliability between 2 authors' TUG times for 20 randomly selected patients was .96.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start16 Jul 2023
- Primary completion1 Nov 2023
- Study completion15 Nov 2023
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 Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rida Khawar Dar, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969873
- Sponsor's protocol ID
- REC/RCR & AHS/23/0727
- Status last verified
- Dec 2023
- First submitted
- 23 Jul 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28.
PubMed 35272439
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
- ClinicalTrials.gov ID
- NCT05969873
- Acronym / sponsor ID
- REC/RCR & AHS/23/0727
- Conditions
- Down Syndrome
- Keywords
- Balance, Contrology, Down syndrome, Pilates, Pediatric Balance Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 1 Aug 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's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. Pilates activities focus on the concept of control of muscles. Pilates increases trunk flexibility, abdominal and core strength and endurance, and deep core muscle activation hence improving balance and posture.
Detailed description
The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy+ Pilates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates exerciseIn this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased. |
| Balance training group | Active comparator | Other: Balance trainingIn this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Down's syndrome children with age between 6 and 12 years.
- The ability to execute required motor skill proficiency and executive function tests.
- The capacity to walk and stand by oneself
Key exclusion criteria (6 listed)
- • Children who are not able to comprehend commands.
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 exerciseAlso: Experimental groupPatients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment. | Other | Pilates Group |
| Balance trainingAlso: Control groupPatients in this group will be treated with balance training and conventional physical therapy as baseline treatment. | Other | Balance training group |
Primary outcome
Pediatric Balance Scale
Time frame: 12 weeks
This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in <20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk
1 secondary outcome
Timed up and go test
Time frame: 12 weeks
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 27 Dec 2023.
- Background: PubMed 35272439Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28.
- Individual participant dataSharing planned: No
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.
Rida Khawar Dar, MS* principal investigator
Riphah International 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 Pilates exercise and Balance training in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 6 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 27 Dec 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 Pakistan. 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?
Pediatric Balance Scale (time frame: 12 weeks). 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 NCT05969873, 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 27 Dec 2023.