Effect of Whole Body Vibration on Down Syndrome

NCT06838754 | Completed DMC

• 1 other identifier: REC/RCR & AHS/24/0716
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Down syndrome; Motor skills; Vibrations

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Whole body vibration therapy

EXPERIMENTAL

Experimental group will receive whole body vibrations while sitting. Walking in all directions,

Other: Whole body vibration therapy

Routine physical therapy

OTHER

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

Interventions

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.

Whole body vibration therapy

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.

Routine physical therapy

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 32134586 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Tuba Sameen, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will receive separate treatment protocols and possible effects will be put to mask the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: February 21, 2025
• Study Start: October 28, 2024
• Primary Completion: February 23, 2025
• Study Completion: March 7, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)