An interventional study of Swiss Ball and Frenkel exercise in Down Syndrome, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Riphah International University · Not applicable, Interventional, and Other
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.
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's planned enrollment of 32 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.
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Exclusion Criteria:
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
Other: Swiss Ball
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
Other: Frenkel exercise
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 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
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.
Time frame: 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. 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
Time frame: 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: 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.
Time frame: 8 weeks
Plan to share: No
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Riphah International University