Swiss Ball Versus Frenkel Exercises Effects in Down Syndrome

NCT06732713 | Recruiting DMC

• 1 other identifier: REC/RCR & AHS/24/0710
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Down Syndrome

Keywords

Down Syndrome; Swiss ball; Frenkel exercises; Static balance; Dynamic balance

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  8 weeks

Study Arms (2)

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

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

Other: Frenkel exercise

Interventions

Swiss Ball OTHER

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

Swiss ball group

Frenkel exercise OTHER

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

Frenkel exercise group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe mental retardation.
• Any heart deficit.
• Visual impairments.
• Musculoskeletal or mobility disorder.
• Hearing impairements.
• Signs of epilepsy or instability of atlanto axial joint

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 34511385 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Layba Marrium, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

9233224390125; Imran.amjad@riphah.edu.pk

Muhammad Asif, MS

CONTACT

03224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 13, 2024
• Study Start: October 11, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)