Autism Spectrum DisorderASDNCT07061119
Effect of Cawthorne Cooksey Exercises on Balance in Autistic Children With Vestibular Hypofunction.
A study testing Conventional treatment and cawthorne cooksey exercises in people with Autism Spectrum Disorder and Vestibular Hypofunction, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder, Vestibular Hypofunction
- What is being tested?
- Conventional treatment and cawthorne cooksey exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Jan 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders
- Peripheral Vestibular hypofunction.
- Age:7-15years
- Children with mild to moderate autism.
- Children who understand and communicate
Who cannot join
- Central Vestibular.
- Acute Infection of inner ear
- Auditory issues.
- Patients unable to follow exercise plan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Islamabad, Pakistan
Islamabad, Fedral, 04403
About this study
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.
Read the detailed description
The complex neurodevelopmental disorder known as autism spectrum disorder (ASD) affects people in a variety of ways, affecting their ability for social interaction, communication, and repetitive behavior. Typically, ASD is recognized and diagnosed in the early childhood years, although its impact can extend throughout a person's life. Autism Spectrum Disorder (ASD) is a type of condition that affects how a child's brain develops. It appears that they have a somewhat different brain than others, which may have an impact on their behavior, social interactions, and communication. It can involve repetitive actions and a strong focus on specific interests. Symptoms of autism differ from person to person depending on age and ability that's why it is called spectrum disorder. Children with autism spectrum disorder appear to exhibit altered postural control when facing challenging situations. Postural control predominantly relies on the automatic system, necessitates focused attention during various straightforward or intricate tasks, and facilitates the regulation of postural control.
Vestibular functioning refers to operation and effectiveness of vestibular system, which is normally concerned with spatial orientation, movement, and balance. The system is located in the inner ear and comprises of semicircular canals (fluid-filled canals) and sensory receptors. Vestibular dysfunction is another common manifestation is autistic patients. It refers to impaired ability to sense and process sensory information associated with balance, movement, and spatial orientation. The manifestations of vestibular dysfunction include apprehensive behaviors when feet do not touch the ground, avoidance of jumping/climbing, and escaping activities like playing with playground equipment. The children usually exhibit toe walking and take more risks while playing. Interventions to improve balance due to vestibular dysfunction include trampoline Jumping, Gym ball exercises, balance board exercises. Balance issues play a huge role in life of an individual with autism. There is indeed a huge gap and lack of literature on how or if exercise protocols from physical therapy can influence balance in individuals with autism. Although, Previous studies have recommended that Balance issues and autism are directly related and that vestibular dysfunction plays a huge role in maintenance of posture. The aim of the study is to investigate the effects of Cawthorne Cooksey exercises on balance. This study will also influence how a physical therapist can improve quality of life of an individual with autism by improving their balance
- Conditions
- Autism Spectrum Disorder, Vestibular Hypofunction
- Being tested
- Conventional treatment, cawthorne cooksey exercises
- Keywords
- Autism, vestibular rehab in children, Autism and balance
- 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.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Conventional treatment include: Trampoline jumping Gym ball exercise:5reps'Sensory diet: Joint compressions Deeppressure Balance board exercises Receives: Other: Conventional treatment |
| Participant Group | Experimental | Cawthorne cooksey exercises Receives: Other: cawthorne cooksey exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start31 Jan 2025
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- Interventional model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061119
- Sponsor's protocol ID
- Bushra Zahid
- Acronym
- ASD
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31949163Mughal S, Faizy RM, Saadabadi A. Autism spectrum disorder. 2018
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cawthorne Cooksey Exercises on Balance in Autistic Children With Vestibular Hypofunction.
- ClinicalTrials.gov ID
- NCT07061119
- Acronym / sponsor ID
- ASD / Bushra Zahid
- Conditions
- Autism Spectrum Disorder, Vestibular Hypofunction
- Keywords
- Autism, vestibular rehab in children, Autism and balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
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.
Detailed description
The complex neurodevelopmental disorder known as autism spectrum disorder (ASD) affects people in a variety of ways, affecting their ability for social interaction, communication, and repetitive behavior. Typically, ASD is recognized and diagnosed in the early childhood years, although its impact can extend throughout a person's life. Autism Spectrum Disorder (ASD) is a type of condition that affects how a child's brain develops. It appears that they have a somewhat different brain than others, which may have an impact on their behavior, social interactions, and communication. It can involve repetitive actions and a strong focus on specific interests. Symptoms of autism differ from person to person depending on age and ability that's why it is called spectrum disorder. Children with autism spectrum disorder appear to exhibit altered postural control when facing challenging situations. Postural control predominantly relies on the automatic system, necessitates focused attention during various straightforward or intricate tasks, and facilitates the regulation of postural control.
Vestibular functioning refers to operation and effectiveness of vestibular system, which is normally concerned with spatial orientation, movement, and balance. The system is located in the inner ear and comprises of semicircular canals (fluid-filled canals) and sensory receptors. Vestibular dysfunction is another common manifestation is autistic patients. It refers to impaired ability to sense and process sensory information associated with balance, movement, and spatial orientation. The manifestations of vestibular dysfunction include apprehensive behaviors when feet do not touch the ground, avoidance of jumping/climbing, and escaping activities like playing with playground equipment. The children usually exhibit toe walking and take more risks while playing. Interventions to improve balance due to vestibular dysfunction include trampoline Jumping, Gym ball exercises, balance board exercises. Balance issues play a huge role in life of an individual with autism. There is indeed a huge gap and lack of literature on how or if exercise protocols from physical therapy can influence balance in individuals with autism. Although, Previous studies have recommended that Balance issues and autism are directly related and that vestibular dysfunction plays a huge role in maintenance of posture. The aim of the study is to investigate the effects of Cawthorne Cooksey exercises on balance. This study will also influence how a physical therapist can improve quality of life of an individual with autism by improving their balance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional model
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Conventional treatmentConventional treatment include: Trampoline jumping Gym ball exercise:5reps'Sensory diet: Joint compressions Deeppressure Balance board exercises |
| Participant Group | Experimental | Other: cawthorne cooksey exercisesCawthorne cooksey exercises |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both genders
- Peripheral Vestibular hypofunction.
- Age:7-15years
- Children with mild to moderate autism.
- Children who understand and communicate
Key exclusion criteria (4 listed)
- Central Vestibular.
- Acute Infection of inner ear
- Auditory issues.
- Patients unable to follow exercise plan
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 |
|---|---|---|
| Conventional treatmentTrampolinejumping: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. | Other | Conventional treatment |
| cawthorne cooksey exercisesCawthorne 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 | Other | Participant Group |
Primary outcome
Pediatric Balance Scale (PBS)
Time frame: 6 Weeks
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.
CTSIB-M
Time frame: 6 Weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 31949163Lord 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.
- BackgroundMughal S, Faizy RM, Saadabadi A. Autism spectrum disorder. 2018
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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.
Nadia Azhar, MS 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 Conventional treatment and cawthorne cooksey exercises in people with Autism Spectrum Disorder and Vestibular Hypofunction, 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Azhar, MS-NMPT (00923335281431, Nadia.azhar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (PBS) (time frame: 6 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 NCT07061119, which also lists 2 linked publications.
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 Jul 2025.