Suspension Therapy Effects on Mobility and Balance in Down Syndrome

NCT06748248 | Recruiting DMC

• 1 other identifier: REC/RCR/AHS/24/Sidra Rukhsar
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pediatric balance scale

  15 to 20 minutes

• Timed Up and Go Test

  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.

Study Arms (2)

suspension therapy

EXPERIMENTAL

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

Routine Treatment

OTHER

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

Interventions

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.

Also known as: universal exercise unit

suspension therapy

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).

Also known as: routine physical Therapy

Routine Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Riphah International Universiy

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Sidra Rukhsar, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad Dr, PhD

CONTACT

9233224390125; Imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS

CONTACT

03224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 27, 2024
• Study Start: September 24, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 15, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)