NCT07248254

Brief Summary

It will be conducted as a Quasi Experimental study across pediatric therapy centers, specialized autism clinics, and special schools. Using non-probability convenience sampling, the study will enroll Autistic children aged 6-10 years who exhibit sensory processing difficulties, motor skill delays, and sleep disturbances. Exclusion criteria include other neurological or developmental disorders and children with major physical problems. Motor skills will be assessed with the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and sleep quality will be measured using the Children's Sleep Habits Questionnaire (CSHQ). Participants will be receiving Wilbarger DPPT along with their usual therapy sessions, which may include general occupational therapy, physical therapy, ABA etc. The DPPT intervention will occur three times per week for six weeks, with each session lasting approximately 30-45 minutes, including brushing, joint compressions, and calming activities. Data will be collected at baseline and post-intervention, focusing on motor skill improvement and sleep quality changes. SPSS version 23 will be used for statistical analysis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Wilbarger Protocol, DPPT, Autism

Outcome Measures

Primary Outcomes (2)

  • Bruininks-Oseretsky test for Motor Proficiency (BOT-2)

    The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) is an individually administered test that uses engaging, goal-directed activities to measure a wide array of motor skills in individuals ages 4 through 21. The BOT-2 uses a subtest and composite structure that highlights motor performance in the broad functional areas of stability, mobility, strength, coordination, and object manipulation.

    Baseline,6 weeks

  • Children Sleep Habits Questionnaire (CSHQ)

    The Children's Sleep Habits Questionnaire (CSHQ) is one of the most commonly used assessment tools for pediatric sleep. It is used both in research and in the clinical field. The CSHQ is a 45-item questionnaire. Each question on the questionnaire is rated on a 3-point scale based on the frequency of occurrence within the past week. Resp Sets are categorized as ''usually'' (5-7 times within the past week), ''sometimes'' (2-4 times within the past week), or ''rarely (never of 1 time within the past week). Some items on the questionnaire are reverse-scored, ensuring that higher scores consistently indicate problem behaviors. All responses are totaled to create a Total Sleep Disturbance index (range from 33 99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder.

    Baseline,6 weeks

Study Arms (1)

Intervention group

OTHER

Participants will receive the Wilbarger Deep Pressure and Proprioceptive Technique (DPPT) along with their usual therapies (OT, PT, ABA) to improve sensory processing, motor skills, and sleep in children with ASD. Sessions will be conducted in a calm setting, with explanations provided to ensure comfort. The DPPT includes 5-10 minutes of deep-pressure brushing using a soft surgical brush on the arms, back, legs, and feet, followed by 5-10 minutes of gentle joint compressions on shoulders, elbows, knees, and ankles (3-5 seconds each). Calming activities like deep breathing or quiet play will follow to aid sensory integration. The intervention will occur thrice weekly for six weeks (30-45 minutes/session). Progress will be measured using BOT-2 for motor skills and CSHQ for sleep at baseline and post-intervention.

Other: Wilbarger Deep Pressure and Proprioceptive Technique (DPPT)

Interventions

Participants will receive the Wilbarger Deep Pressure and Proprioceptive Technique (DPPT). Each session will begin in a calm, quiet environment to reduce distractions, with the therapist explaining the process in simple terms. The brushing protocol involves using a soft surgical brush to apply firm yet gentle deep pressure to the arms, back, legs, and feet for about 5-10 minutes. This is followed by gentle joint compressions to the shoulders, elbows, knees, and ankles, each held for 3-5 seconds, lasting another 5-10 minutes. Afterward, calming activities such as deep breathing or quiet play help the child integrate the sensory input. The DPPT will be administered three times per week for six weeks, with each session lasting approximately 30-45 minutes, including brushing, joint compressions, and calming activities.

Intervention group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with Autism
  • Both Genders Males and Females
  • Age 6-11
  • Autistic children diagnosed with sensory processing disorder and reported with motor skill delays and sleep disturbances.
  • Children scoring within the "Definite Difference" range in sensory processing areas on the Sensory Profile 2.

You may not qualify if:

  • Children with other neurological or Developmental disorders
  • No serious physical or behavioral impairments (blindness and deafness)
  • Children with multiple diagnosis along with ASD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mind Care Therapy Centre

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

  • Schoen SA, Schaaf RC, Mailloux Z, Bundy A, Lane S, May-Benson TA, Parham LD, Roley SS. Response: Commentary: Evaluating Sensory Integration/Sensory Processing Treatment: Issues and Analysis. Front Integr Neurosci. 2022 Jun 7;16:874320. doi: 10.3389/fnint.2022.874320. eCollection 2022. No abstract available.

    PMID: 35747497BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • AIZA ZAMIR, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed,, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A quasi-experimental study will be conducted across pediatric therapy centers, autism clinics, and special schools using convenience sampling. Autistic children aged 6-10 years with sensory processing difficulties, motor delays, and sleep disturbances will be included, excluding those with other neurological or major physical disorders. Motor skills will be assessed using the BOT-2 and sleep quality with the CSHQ. Participants will receive the Wilbarger DPPT along with routine therapies (e.g., OT, PT, ABA) three times weekly for six weeks (30-45 min/session). Data will be collected at baseline and post-intervention to assess motor and sleep improvements. Statistical analysis will be performed using SPSS v23.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

October 29, 2025

Primary Completion

February 20, 2026

Study Completion

February 23, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations