Effect of Whole Body Vibration on Down Syndrome

Effects of Whole Body Vibration on Gait Parameters and Postural Control in Children With Down Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Whole body vibration therapy; Other: Routine physical therapy

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54700
      • Riphah International University

Participation Criteria

Eligibility Criteria

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

Description

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 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: Whole body vibration therapy; Experimental group will receive whole body vibrations while sitting. Walking in all directions,	Other: Whole body vibration therapy; Experimental group will get whole body vibrations. WBV will be performed by the patient while seated on the vibrating plate's base. Five series with a 30-second wait will make up each session. Five minutes and thirty seconds will be spent on vibration, and twenty minutes and thirty seconds will be spent on exercise. 5 Hz will be the frequency utilized. Over the course of two months, 16 classes will be held twice a week.
Other: Routine physical therapy; Group B will be the only one performing routine physical therapy (RPT). Stretching exercises will be part of these regular workouts. Walking in all directions,	Other: Routine physical therapy; Group B will only get routine physical therapy. Walking in all directions, advancing past the point of stability in a variety of positions, including half-kneeling, standing on both soft and hard surfaces, stepping up and down, walking and standing simultaneously, and standing on one leg with eyes open and closed were all part of the postural control exercise. There will be a 20-minute session.As each participant's functional improvement progresses, the intensity of the workout program will progressively rise. There will be 16 sessions in total (two days a week), with 8 sessions for each group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	Step length will be measured from consecutive heel contacts in cm.	2 months.
Posture and postural ability test (PPAS)	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.	2 months.
Stride length	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.	2 months.
Step width	Step width will be measured from the mediolateral space between the two feet in cm.	2 months.
Foot angle	Foot angle will be measured by the angle between the line of progression and the foot axis in degree.	2 months.

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Tuba Sameen, MS*, Riphah International University

Publications and helpful links

General Publications

• Yaqoob M, Manzoor J, Hyder SN, Sadiq M. Congenital heart disease and thyroid dysfunction in Down syndrome reported at Children;s Hospital, Lahore, Pakistan. Turk J Pediatr. 2019;61(6):915-924. doi: 10.24953/turkjped.2019.06.013.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): February 23, 2025
• Study Completion (Actual): March 7, 2025

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Down syndrome; Motor skills; Vibrations
• 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/24/0716

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