Riphah Rehabilitation Center
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT07757035
This randomized controlled trial aims to evaluate the efficacy of low-frequency Whole Body Vibration therapy on motor skills and sensory integration in children aged 5-9 years diagnosed with mild to moderate ASD.
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Notify Me5 year–9 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social communication and restrictive, repetitive behaviors. While core symptoms often receive priority in diagnosis and intervention, motor coordination difficulties and sensory integration challenges-present in a significant proportion of autistic children- remain underexplored. Research shows that up to 83% of children with ASD struggle with age-appropriate motor skills, and sensory processing abnormalities further hinder their participation in daily routines. Traditional therapies, although beneficial, often fail to address these interconnected domains comprehensively. Whole-body vibration (WBV) therapy, a non-invasive physical intervention that stimulates neuromuscular function through low frequency vibrations, has shown promise in improving motor control, coordination, and even behavioral outcomes in various clinical populations, including children with cerebral palsy and Down syndrome. However, its application in pediatric ASD, particularly for sensory and motor integration, remains limited in empirical evidence. This randomized controlled trial aims to evaluate the efficacy of low-frequency Whole Body Vibration therapy on motor skills and sensory integration in children aged 3-10 years diagnosed with mild to moderate ASD. The study will be conducted over 10 months at two pediatric rehabilitation centers in Pakistan and will involve 36 participants divided into intervention and control groups. The intervention group will receive low-frequency Whole Body Vibration sessions combined with routine physiotherapy, while the control group will engage in routine physical activity. Motor skills will be assessed using the Test of Gross Motor Development-2 (TGMD-2), and sensory processing will be evaluated with the Short Sensory Profile. The vibration protocol includes 3-4 rounds of 30-second sessions with rest intervals, using a platform set at 28 Hz and 0.97 mm amplitude. Data will be analyzed using SPSS 27.0.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants in this group will receive the low-frequency whole-body vibration therapy along with routine physical activity For whole body vibration: Frequency: 5 Hz Amplitude: 2.5 mm Each session will include 5 vibration periods, each lasting 30 seconds. A 1min rest interval will be provided. A 5-minute post-session observation period will be conducted to monitor behavioral or physiological response Each participant will undergo between 10 and 40 individual sessions, depending on their tolerance and the requirement for data stability.
Walk/Jog session at moderate intensity during the early hours of the day. 10 min session per day. 5 session per week
Time frame: 8 weeks
TGMD-2 includes motor exercises that are focused on improving motor performance levels. The first part of the locomotor subtest exercises includes a run, gallop, hop, leap, horizontal jump and slide. The second part of the object control subtest exercises includes striking a stationary ball, stationary dribble, catch, kick, overhand throw and underhand roll. During the test, each child had to perform each exercise twice. A total of 3- 5 performance criteria were used for the evaluation. If the given criterion was not performed correctly, it was marked 0. Conversely, if the given criterion was performed correctly, it was marked 1. The internal consistency of the TGMD-2 was found to be high (alpha = 0.71-0.72) and the interrater, interrater, and test-retest reliability acceptable (ICCs ranging from 0.82 to 0.95)
Time frame: 8 weeks
The Sensory Profile Questionnaire is a 125-item tool designed for use with children aged 3 to 10 years. It employs a 5-point Likert scale and covers eight sensory categories: Auditory, Visual, Taste/Smell, Movement, Body Position, Touch, Activity Level, and Emotional/Social. Scores are calculated individually for three main sections-Sensory Processing, Modulation, and Behavioral and Emotional Responses-as well as for each specific factor. A lower total score on the SPCQ indicates greater sensory processing difficulties.
Riphah International University
Other
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