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NCT Number: NCT06748248

Suspension Therapy Effects on Mobility and Balance in Down Syndrome

Down syndrome (DS) is one of the most common congenital disorders. 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. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University, Lahore, Punjab Province, Pakistan

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About this study

The current study will be Randomized Controlled Trial. Inclusion criteria for the study will be children with Down syndrome (DS) of mild to moderate mental retardation aged between 3 and 6 years. Patients with any cardiac issue and orthopedic limitation to exercise such as hip, knee, foot or spinal deformities will be excluded from the study. A sample of 26 children with DS will be selected from both genders. Tools used for data collection will be Pediatric Balance scale (PBS), Four square step test (FSST), Timed up and Go test (TUG) and 1Minute Walk Test (1MWT). Participants will be measured before and after treatment to assess changes. Interventions are carried out 5 days in a week for one hour daily. In this study descriptive statistical tools will used to analyze the data. Data will be analyzed through SPSS version 23.00.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

• Diagnosed children with Down syndrome with mild (IQ: 69-50) to moderate (IQ: 50-35) mental retardation

  • Aged between 3 to 6 years
  • Both gender
  • Able to follow the instructions
  • Able to stand and walk

Exclusion criteria

• Any Cardiovascular disease

  • Visual and Hearing impairment
  • Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities

Treatment and study plan

suspension Therapy

Other

suspension therapy for individuals with Down syndrome is an approach that focuses on improving mobility and balance through different activities that will be conducted through universal exercise unit. This method involves organizing individuals with Down syndrome into two groups. Group A will perform Suspension Therapy in addition to routine physical therapy. These routine exercises will consist of stretching exercises (arm raises, chest stretch, leg swings, hamstring stretch, cat-cow poses, starfish stretch), strength and endurance training (like stepping, carrying light weights) and balance training (playing hopscotch and kicking a ball). The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. Suspension Therapy will consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. Repeated corrective movements will be performed.

Other names: universal exercise unit

Routine Treatment

Other

Group B will perform routine physical therapy (RPT) alone. These routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improvement. These exercises will be carried out 5 days in a week for one hour daily.

Data will be assessed by assessor at baseline and at the end of 5th session of treatment (Pre and post).

Other names: routine physical Therapy

Primary outcomes

  1. 1 Minute Walk Test

    Time frame: 1 minute

    The distance covered during the 1 minute walk test was compared with the children gross motor function as assessed by the Gross Motor Function Measure. We concluded that the 1 Minute Walk Test is a valid measure for assessing functional ability in children with bilateral spastic cerebral palsy. Its cost effectiveness and user friendliness make it a potentially useful tool in the clinical setting. The test retest reliability of a 1 minute walk test at a child maximum walking speed was assessed in children with bilateral spastic cerebral palsy. A 1 minute walk test is a reliable method of assessing function in children with Cerebral palsy but care must be taken when interpreting changes in individual patient data.

  2. Four Square Step Test

    Time frame: 15 seconds

    Four Square Step Test is a tool for measuring balance in children with Down syndrome by stepping over four squares. The Four Square Step Test is a balance and mobility assessment that evaluates a persons ability to step quickly and accurately in multiple directions. Participants step in and out of four squares arranged in a cross pattern starting from one of the outer squares and moving through a sequence. The test is timed and results help identify balance impairments and fall risks. A completion time of under 15 seconds is generally considered normal.

Secondary outcomes

  1. Pediatric balance scale

    Time frame: 15 to 20 minutes

    The Pediatric Balance Scale a modification of the Berg Balance Scale will be used as a balance measure for children. The pediatric balance scale measure can be performed without specialized equipment and is quickly and easily administered. The Pediatric balance scale has been used to measure the balance functions for school age children with mild to moderate motor impairment and children with Cerebral palsy. The tasks range from timed sitting balance to standing on one leg. This study confirmed good validity of the Pediatric balance scale and its capability to predict motor function and Activity of daily living at follow up. The Pediatric balance scale static dynamic and total were moderately responsive to change.

  2. Timed Up and Go Test

    Time frame: The Timed Up and Go Test typically takes about 5 to 10 minutes to complete. This includes time for instructions the actual test which usually lasts 10 to 30 seconds depending on the individual and scoring.

    The Timed Up and Go Test is a quick assessment used to evaluate mobility and balance primarily in older adults. It measures the time it takes for a participant to stand up from a chair walk 3 meters or 10 feet turn around walk back and sit down. The total time is recorded with results helping to identify fall risk and assess functional mobility. A completion time under 10 seconds is typically considered normal while over 12 seconds may indicate an increased risk of falls.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad Dr, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS

CONTACT

[email protected]

03224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome

Acronym: STOMP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 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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