Clinical trial NCT06838754: Effect of Whole Body Vibration on Down Syndrome
Official title: Effects of Whole Body Vibration on Gait Parameters and Postural Control in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
Motor skills
Vibrations
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be randomised control trial in which non probability snowball sampling will be used. Two groups of 5-12 age will be performed in which participants will be randomly divided. Group A will be receive Whole body Vibrations and routine physical therapy and Group B will be receive routine therapy.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Step length
timeFrame: 2 months.
measure: Posture and postural ability test (PPAS)
timeFrame: 2 months.
measure: Stride length
timeFrame: 2 months.
measure: Step width
timeFrame: 2 months.
measure: Foot angle
timeFrame: 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tuba Sameen, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.