Suspension Therapy Effects on Mobility and Balance in Down Syndrome (STOMP)

Effects of Suspension Therapy on Mobility and Balance in Children With 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.

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome (DS)
• Intervention / Treatment: Other: suspension Therapy; Other: Routine Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Asif Javed, MS; Phone Number: 03224209422; Email: a.javed@riphah.edu.pk
• Study Contact Backup: Name: Imran Amjad Dr, PhD; Phone Number: 9233224390125; Email: Imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Riphah International University
      • Contact: Muhammad Asif Javed, MS; Phone Number: 03224209422; Email: a.javed@riphah.edu.pk
      • Contact: IMRAN AMJAD, PhD; Phone Number: 9233224390125; Email: imran.amjad@riphah.edu.pk
      • Principal Investigator: Sidra Rukhsar, MS
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Riphah international universiy
      • Contact: IMRAN AMJAD, PHD; Phone Number: +9233224390125; Email: imran.amjad@riphah.edu.pk
      • Contact: Muhammad Asif Javed, MS; Phone Number: 03224209422; Email: a.javed@riphah.edu.pk
      • Principal Investigator: Sidra Rukhsar, MS*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suspension therapy; Universal Exercise Unit also named Spider cage and Monkey cage. This device will used in this study. This system helps the children to weight shift, more independent movement and assisted movement such as sit to stand, squats and jumping.	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, 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
Other: Routine Treatment; 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.	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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 Minute Walk Test	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.	1 minute
Four Square Step Test	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.	15 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric balance scale	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.	15 to 20 minutes
Timed Up and Go Test	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.	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.

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sidra Rukhsar, MS, Riphah International University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Down syndrome; Pediatric Balance Scale; Suspension Therapy; Universal Exercise Unit; four Square Step Test; 1min Walk Test; Timed up and go test
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Genetic Diseases, Inborn; Disease; Neurobehavioral Manifestations; Congenital Abnormalities; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: REC/RCR/AHS/24/Sidra Rukhsar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No