NCT07061119

Brief Summary

The objective of the study is to determine the effects of cawthorne cooksey exercises on balance in autistic children with vestibular hypofunction. The study will be randomized control trial including 2 experimental groups with estimated 22 participants in each group.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

January 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 2, 2025

Last Update Submit

July 2, 2025

Conditions

Autism Spectrum DisorderVestibular Hypofunction

Keywords

Autism, vestibular rehab in children, Autism and balance

Outcome Measures

Primary Outcomes (2)

  • Pediatric Balance Scale (PBS)

    Adapted from the Berg Balance Scale for pediatric use.Assesses flexibility in changing postures and overall postures. - Comprises 14 different balance- related tasks, scored from 0 to 4. Used to assess functional balance skills and motor disorders in school-aged children.

    6 Weeks

  • CTSIB-M

    This test is aimed to asses' sensory input when one or more sensory system is compromised. It Assess balance (either vestibular or non- vestibular). It consists of 4 different conditions; 4 conditions e.g. eye open/ eye close and firm surface. Eyes open/ eye close foam surface. each consist of 3 trials. Total time 30 sec for each trial and total score is 120. Excellent reliability and validity.

    6 Weeks

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Conventional treatment include: Trampoline jumping Gym ball exercise:5reps'Sensory diet: Joint compressions Deeppressure Balance board exercises

Other: Conventional treatment

Participant Group

EXPERIMENTAL

Cawthorne cooksey exercises

Other: cawthorne cooksey exercises

Interventions

Conventional treatmentOTHER

Trampolinejumping:5times. Gym ball exercise:5reps'Sensory diet:- Joint compressions: 1 set x 10reps on limbs, neck, and head region. Deeppressure:1 setx10reps. Balance board exercises.

Conventional treatment
cawthorne cooksey exercisesOTHER

Cawthorne Cooksey exercises * Start with low to moderate intensity. * Gradually increase range, speed, and Complexity over time * Trampoline jumping- Gym ball exercise- Sensory diet * Cawthorne Cooksey exer cise Training Phase1-In bed exerercises:- Eye movements: 1)Up and down 2)Side to side 3)Moving finger away from face * Phase2-Sitting: Eye movements as above. Head movements at firsts low, then quick later with eyes closed * bending forward and backward * turning from side to side. --Shoulder shrugging and circling * Bending forward and picking up objects from the ground * Phase 3 - Standing: * Eye, Head, Shoulder movements * Throwing ball from hand to hand, hand under knee * Switch to sitting to standing and turning around in between. * Phase 4 - Walk: with eyes closed and open: * Across room * Slope and Stairs

Participant Group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both genders
  • Peripheral Vestibular hypofunction.
  • Age:7-15years
  • Children with mild to moderate autism.
  • Children who understand and communicate

You may not qualify if:

  • Central Vestibular.
  • Acute Infection of inner ear
  • Auditory issues.
  • Patients unable to follow exercise plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad, Pakistan

Islamabad, Fedral, 04403, Pakistan

RECRUITING

Related Publications (2)

  • Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.

    PMID: 31949163BACKGROUND

  • Mughal S, Faizy RM, Saadabadi A. Autism spectrum disorder. 2018

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nadia Azhar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Azhar, MS-NMPT

CONTACT

00923335281431Nadia.azhar@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

January 31, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations

PA(1)