Down SyndromeNCT06732713
Swiss Ball Versus Frenkel Exercises Effects in Down Syndrome
A study testing Swiss Ball and Frenkel exercise in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Swiss Ball and Frenkel exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Oct 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients diagnosed with Down syndrome.
- Age between 8 to 13 years.
- Patient able to understand instructions necessary for intervention.
- Independent standing and walking abilities.
- Both the genders were included
Who cannot join
- Severe mental retardation.
- Any heart deficit.
- Visual impairments.
- Musculoskeletal or mobility disorder.
- Hearing impairements.
- Signs of epilepsy or instability of atlanto axial joint
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects Of Swiss Ball Versus Frenkel Exercises on Static and Dynamic Balance in Children With Down Syndrome.
Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.
Read the detailed description
Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.
The current study will be randomized clinical trial, data will be collected from Children Hospital and Institute of Child Health, Lahore. The study will include 32 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlanto occipital joint will be excluded. Sample will be divided into two groups.
Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 23.00.
- Conditions
- Down Syndrome
- Being tested
- Swiss Ball, Frenkel exercise
- Keywords
- Down Syndrome, Swiss ball, Frenkel exercises, Static balance, Dynamic balance
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swiss BallOther
Swiss ball exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes , 3 to 4 sessions per week for 8 weeks
Frenkel exerciseOther
Frenkel exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes, 3 to 4 sessions per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Swiss ball group | Experimental | Swiss ball exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes Receives: Other: Swiss Ball |
| Frenkel exercise group | Experimental | Frenkel exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes Receives: Other: Frenkel exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 8 weeks
Timed up and Go test
The 'timed up and go' test (TUG) is a simple, quick and widely used clinical performance- based measure of lower extremity function, mobility and fall risk.
- Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
- On the word "Go," begin timing.
- Stop timing after patient sits back down.
- Record the time. The TUG has demonstrated good test-retest reliability (ICC 0.80-0.99), validity, and sensitivity to change. It has a moderate correlation with fall risk
Measured: 8 weeks
Romberg test
Ask the subject to stand erect with feet together and eyes closed. Stand close by as a precaution in order to stop the person from falling over. Watch the movement of the body in relation to a perpendicular object behind the subject (corner of the room, door, window etc.). A positive sign is noted when a swaying, sometimes irregular swaying and even toppling over occurs. The essential feature is that the patient becomes more unsteady with eyes closed. The essential features of the test are as follows:
- the subject stands with feet together, eyes open and hands by the sides.
- the subject closes the eyes while the examiner observes for a full minute. Romberg's test is positive if the patient falls while the eyes are closed. Swaying is not a positive sign as it shows proprioceptive correction.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start11 Oct 2024
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study will be randomized clinical. The study will include 32 patients aged between 8 to 13 years equally divided into two groups and randomly allocated trial. Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Layba Marrium, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732713
- Sponsor's protocol ID
- REC/RCR & AHS/24/0710
- Status last verified
- Jan 2025
- First submitted
- 3 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shields N. Physiotherapy management of Down syndrome. J Physiother. 2021 Oct;67(4):243-251. doi: 10.1016/j.jphys.2021.08.016. Epub 2021 Sep 10. No abstract available.
PubMed 34511385
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Swiss Ball Versus Frenkel Exercises on Static and Dynamic Balance in Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT06732713
- Acronym / sponsor ID
- REC/RCR & AHS/24/0710
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Swiss ball, Frenkel exercises, Static balance, Dynamic balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 13 Dec 2024 (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 (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.
Detailed description
Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.
The current study will be randomized clinical trial, data will be collected from Children Hospital and Institute of Child Health, Lahore. The study will include 32 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlanto occipital joint will be excluded. Sample will be divided into two groups.
Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 23.00.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The current study will be randomized clinical. The study will include 32 patients aged between 8 to 13 years equally divided into two groups and randomly allocated trial. Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test.
| Arm | Type | Receives |
|---|---|---|
| Swiss ball group | Experimental | Other: Swiss BallSwiss ball exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes |
| Frenkel exercise group | Experimental | Other: Frenkel exerciseFrenkel exercises will be done and intervention period will be of 8 weeks with 3 to 4 sessions per week of about 25 to 30 minutes |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed with Down syndrome.
- Age between 8 to 13 years.
- Patient able to understand instructions necessary for intervention.
- Independent standing and walking abilities.
- Both the genders were included
Key exclusion criteria (6 listed)
- Severe mental retardation.
- Any heart deficit.
- Visual impairments.
- Musculoskeletal or mobility disorder.
- Hearing impairements.
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 |
|---|---|---|
| Swiss BallSwiss ball exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes , 3 to 4 sessions per week for 8 weeks | Other | Swiss ball group |
| Frenkel exerciseFrenkel exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes, 3 to 4 sessions per week for 8 weeks | Other | Frenkel exercise group |
Primary outcome
Pediatric Balance Scale
Time frame: 8 weeks
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Timed up and Go test
Time frame: 8 weeks
The 'timed up and go' test (TUG) is a simple, quick and widely used clinical performance- based measure of lower extremity function, mobility and fall risk. 1. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 2. On the word "Go," begin timing. 3. Stop timing after patient sits back down. 4. Record the time. The TUG has demonstrated good test-retest reliability (ICC 0.80-0.99), validity, and sensitivity to change. It has a moderate correlation with fall risk
Romberg test
Time frame: 8 weeks
Ask the subject to stand erect with feet together and eyes closed. Stand close by as a precaution in order to stop the person from falling over. Watch the movement of the body in relation to a perpendicular object behind the subject (corner of the room, door, window etc.). A positive sign is noted when a swaying, sometimes irregular swaying and even toppling over occurs. The essential feature is that the patient becomes more unsteady with eyes closed. The essential features of the test are as follows: 1. the subject stands with feet together, eyes open and hands by the sides. 2. the subject closes the eyes while the examiner observes for a full minute. Romberg's test is positive if the patient falls while the eyes are closed. Swaying is not a positive sign as it shows proprioceptive correction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 34511385Shields N. Physiotherapy management of Down syndrome. J Physiother. 2021 Oct;67(4):243-251. doi: 10.1016/j.jphys.2021.08.016. Epub 2021 Sep 10. No abstract available.
- Individual participant dataSharing planned: No
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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.
Layba Marrium, 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 Swiss Ball and Frenkel exercise 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 5 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT06732713, 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 Jan 2025.