NCT07757035

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

May 5, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

autismmotor skillssensory integration

Outcome Measures

Primary Outcomes (2)

  • Test for Gross motor function-2 (TGMD-2)

    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)

    8 weeks

  • Sensory profile questionnaire

    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.

    8 weeks

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

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 between each vibration period. Upon completion of each session, the participant will be taken immediately to the observation room. 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.

Other: whole body vibration

Routine physical therapy group

OTHER

10 min session per day. 5 session per week. Walk/Jog session at moderate intensity during the early hours of the day.

Other: Routine physical therapy

Interventions

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.

Whole body vibration group

Walk/Jog session at moderate intensity during the early hours of the day. 10 min session per day. 5 session per week

Routine physical therapy group

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-9 years
  • Clinically diagnosed with mild to moderate Autism Spectrum Disorder according to the childhood autism rating scale (CARS)
  • Able to stand or sit with support on a WBV platform
  • Children able to follow simple verbal commands
  • Children with no visual or auditory defects
  • Parental/legal guardian consent obtained
  • Attending regular therapy sessions at the study site

You may not qualify if:

  • Children with uncontrolled epilepsy and cerebral palsy
  • Severe musculoskeletal or orthopedic impairments
  • Presence of implanted medical devices (e.g., pacemaker)
  • Any recent surgery (\<6 months)
  • Children currently undergoing another experimental therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Monz BU, Houghton R, Law K, Loss G. Treatment patterns in children with autism in the United States. Autism Res. 2019 Mar;12(3):517-526. doi: 10.1002/aur.2070. Epub 2019 Jan 10.

    PMID: 30629336BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hina Manzoor, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

August 11, 2026

Study Start

April 15, 2026

Primary Completion

July 5, 2026

Study Completion

July 10, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations