Effect of Whole Body Vibration on Down Syndrome

Not Applicable

Completed

• Conditions: Down Syndrome

• Registration Number: NCT06838754
• Lead Sponsor: Riphah International University

Brief Summary

A congenital condition known as Down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. Development of the body and brain may be impacted. About 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. Heart disease, hypotonia, ligament laxity, cerebral disabilities, thyroid abnormalities, and metabolic diseases are among the physical, cognitive, and metabolic changes that define it. Reduced performance, increased energy consumption, and altered gait patterns are frequently the results of motor disorders. This study intends to ascertain the effects of whole body vibrations (WBV), an activity that has been recommended for individuals with Down syndrome, on gait parameters and postural control in children with this condition.

Detailed Description

Whole Body Vibration (WBV) and routine physical therapy (RPT) are given to Group A, whereas routine physical therapy is given to Group B as a control. Two sessions of 20 minutes each are given to both groups twice a week. Postural control and gait metrics are the outcomes that will be examined. The present investigation will be conducted over a two-month period and will be a randomized control experiment. Alkhidmat Hospital in Sargodha and Al-Ghafoor Hospital in Bhera will provide the data. 16 participants will participate in the trial; they will be randomly assigned to two equal groups. Children with DS, ages 5 to 12, of both sexes, will be eligible to participate in the study. The condition of improved comprehension of children older than five years was taken into consideration when determining the inclusion criteria.

Study Timeline

• Study Start: 2024-10-28
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-21
• Primary Completion: 2025-02-23
• Status Verified: 2025-03
• Study Completion: 2025-03-07
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Ages 5-12
• Both sexes are chosen
• Children with Down syndrome older than 5 who are more knowledgeable about the exercise to be done are given preference.

Exclusion Criteria

• Children with cardiac conditions and other conditions
• Atlantoaxial instability and prosthesis implantation are excluded.
• DS kids who don't have their parents or legal guardians sign the consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Step length	2 months.	Step length will be measured from consecutive heel contacts in cm.
Posture and postural ability test (PPAS)	2 months.	The PPAS assesses 4 positions. Standing, sitting, supine and prone Each position is assessed according to the postural ability, quality of posture and within postural ability seven levels are designated, ranging from Level 1 = 'Unplaceable in an aligned posture' to 7 = Able to move into and out of position.
Stride length	2 months.	Stride length is the distance between the previous heel strike of the right foot and the new heel strike of the right foot and measured in cm.
Step width	2 months.	Step width will be measured from the mediolateral space between the two feet in cm.
Foot angle	2 months.	Foot angle will be measured by the angle between the line of progression and the foot axis in degree.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan