Autism Spectrum DisorderNCT07757035
Effects of Low Frequency Whole Body Vibrations on Motor Skills and Sensory Integration in Children With Autism
A study testing whole body vibration and Routine physical therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- whole body vibration and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- whole body vibration, Routine physical therapy
- Keywords
- autism, motor skills, sensory integration
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationOther
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.
Routine physical therapyOther
Walk/Jog session at moderate intensity during the early hours of the day. 10 min session per day. 5 session per week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Apr 2026
- Primary completion5 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hina Manzoor, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757035
- Sponsor's protocol ID
- REC/RCR & AHS/25/0704
- Status last verified
- Aug 2026
- First submitted
- 5 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30629336
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Frequency Whole Body Vibrations on Motor Skills and Sensory Integration in Children With Autism
- ClinicalTrials.gov ID
- NCT07757035
- Acronym / sponsor ID
- REC/RCR & AHS/25/0704
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, motor skills, sensory integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration group | Experimental | Other: whole body vibrationThe 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. |
| Routine physical therapy group | Other | Other: Routine physical therapy10 min session per day. 5 session per week. Walk/Jog session at moderate intensity during the early hours of the day. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibrationThe 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. | Other | Whole body vibration group |
| Routine physical therapyWalk/Jog session at moderate intensity during the early hours of the day. 10 min session per day. 5 session per week | Other | Routine physical therapy group |
Primary outcome
Test for Gross motor function-2 (TGMD-2)
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)
Sensory profile questionnaire
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 30629336Monz 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.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Manzoor, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and Routine physical therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test for Gross motor function-2 (TGMD-2) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.