Clinical trial NCT06748248: Suspension Therapy Effects on Mobility and Balance in Down Syndrome
Official title: Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome (DS)
Keywords: Down syndrome
Suspension Therapy
Universal Exercise Unit
Pediatric Balance Scale
four Square Step Test
1min Walk Test
Timed up and go test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be randomized control trial in which non probability convenient sampling will be used. two groups of 3-6 age will be formed in which participants will be randomly divided. Group A will be receive Suspension Therapy. Group B will be receive routine therapy.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: 1 Minute Walk Test
timeFrame: 1 minute
measure: Four Square Step Test
timeFrame: 15 seconds
Secondary outcomes:
measure: Pediatric balance scale
timeFrame: 15 to 20 minutes
measure: Timed Up and Go Test
timeFrame: 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.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah International Universiy
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Rukhsar, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.