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NCT Number: NCT06838754

Effect of Whole Body Vibration on 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.

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole body vibration therapy

Other

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.

Routine physical therapy

Other

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.

Primary outcomes

  1. Step length

    Time frame: 2 months.

    Step length will be measured from consecutive heel contacts in cm.

  2. Posture and postural ability test (PPAS)

    Time frame: 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.

  3. Stride length

    Time frame: 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.

  4. Step width

    Time frame: 2 months.

    Step width will be measured from the mediolateral space between the two feet in cm.

  5. Foot angle

    Time frame: 2 months.

    Foot angle will be measured by the angle between the line of progression and the foot axis in degree.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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