Suspension Therapy Effects on Mobility and Balance in Down Syndrome

NCT ID: NCT06748248

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-24
• Study Completion Date: 2025-01-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

suspension Therapy

Intervention Type: 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.

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.

Group Type: OTHER

Routine Treatment

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Other Intervention Names

universal exercise unit; routine physical Therapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sidra Rukhsar, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Riphah International Universiy

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad Dr, PhD

Role: CONTACT

Phone: 9233224390125

Email: Imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS

Role: CONTACT

Phone: 03224209422

Email: a.javed@riphah.edu.pk

Facility Contacts

Imran Amjad, PhD

Role: primary

Muhammad Asif Javed, MS

Role: backup

Imran Amjad, PhD

Role: primary

Muhammad Asif Javed, MS

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 38081839 (View on PubMed)

Other Identifiers

REC/RCR/AHS/24/Sidra Rukhsar

Identifier Type: -

Identifier Source: org_study_id