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Recruiting NCT06748248

Suspension Therapy Effects on Mobility and Balance in Down Syndrome

No phase Interventional Down Syndrome (DS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: suspension Therapy, Routine Treatment.
Who it may be relevant to
Registry conditions: Down Syndrome (DS). Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other suspension Therapy
    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, sta
  • Other Routine Treatment
    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 improv

Primary outcome measures

  • 1 Minute Walk Test [Time frame: 1 minute]
  • Four Square Step Test [Time frame: 15 seconds]
Secondary outcome measures (2)
  • Pediatric balance scale [Time frame: 15 to 20 minutes]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Riphah International University — Lahore
  • Riphah International Universiy — Lahore

Publications

  • Mendez-Martinez M, Rodriguez-Grande EI. Effects of therapeutic exercise on the motor function of adults with Down syndrome: a systematic review and meta-analysis. Sci Rep. 2023 Dec 11;13(1):21962. doi: 10.1038/s41598-023-48179-1. PMID 38081839

Identifiers

NCT: NCT06748248 · REC/RCR/AHS/24/Sidra Rukhsar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗