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NCT Number: NCT06407895

Effects of Lower Limb Fitness Program in Children With DS

Down Syndrome is a congenital disorder resulting from the trisomy of the human chromosome 21, which will determine, among other characteristics, intellectual disability and growth retardation. Reduced muscular strength, cardiovascular capacity, sleep problems, and impaired walking performance are also observed in Down syndrome participants. The estimated global prevalence is around 0.1% of live births. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities are theorized to impair their overall physical health and ability to perform daily activities. Posture, balance, and movement issues are common in children with Down syndrome. The purpose of this study is to examine the effects of Lower Limb Fitness Program on dynamic balance and mobility in children with Down Syndrome. This study explore that Lower Limb Fitness Program could improve the dynamic balance and mobility in children with DS.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

Group A: Experimental group:

Group A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. This intervention aims to get the muscles ready before the actual intervention and improve proprioceptive ability. Exercises will be given three times a week for 6 weeks with session conducting 45 minutes per sessions which involve Squat-to-stand training will repeat 30 times 3 sets for 20 min. 2minute break after 1 set.. Balance training which involves standing activities with support, progressing to unsupported as tolerated for 10 minutes/session.

Group B: Control group:

In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.

Data will be assessed by assessor at baseline by single leg stance test and at the end of 6th session of treatment (Pre and post).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-12 years
  • Both Genders.
  • Single leg stance Test: If unable to stand for 5 seconds or less client at greater risk of injury from fall.
  • Ability to understand and follow basic instructions.
  • Deficits in Balance

Exclusion criteria

  • Children who are unable to engage in a structured fitness program due to behavioral or physical limitations.
  • Children who have undergone lower limb surgery or experienced significant lower limb injuries in the past six months

Treatment and study plan

Lower Limb Fitness Program

Other

the stability of the core area can help to improve dynamic balance, coordinate the upper and lower trunk muscles, and reduce muscles' damage and abnormalities. Physiotherapy had a role in programming training for Down Syndrome children, for example, using squat to stand training that seemed to improving lower extremity muscle power. Squat-to-stand training will stimulate the proprioceptive stimulation on the trunk and lower extremity

routine therapy

Other

In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.

Primary outcomes

  1. Timed up and go test

    Time frame: 6 weeks

    The TUG test assesses the participant's mobility by timing how quickly they can complete the test and dynamic balance by assessing their ability to sit-to-stand, stand-to-sit, walk, and their ability to change directions. The participant stood up from a chair (46 cm seat height) with no armrests, walked 10 feet, turned around, walked back to the chair, and sat back down as quickly as possible

  2. Pediatric Balance scale

    Time frame: 6 weeks

    Pediatric version of balance scale is used to evaluate static and dynamic balance in children aged 3-15 years with mild-to-moderate motor impairment. The scale comprises 14 items including sitting balance, standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, retrieving object from floor, turning, and placing foot on stool items. Each item is scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

  3. Modified Clinical Test of Sensory Interaction in Balance (CTSIB-M)

    Time frame: 6 weeks

    This test is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the older adult must rely on the somatosensory and vestibular systems to balance

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Lower Limb Fitness Program in Children With Down Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 9, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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