Autism Spectrum DisorderNCT06340139
Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder
A study testing conventional treatment and experimental treatment in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- conventional treatment and experimental treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2024to 20 Aug 2024
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-18 years
- Both male and female
- Diagnosed Autism Spectrum disorder.
- Visual and/or Vestibular stimming diagnosed by physician.
Who cannot join
- Patients diagnosed with other neurological diseases
- Tumors or neoplasms
- Visual and auditory impairments
- Inability to respond to verbal command through verbal or non-verbal communication cues.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
zamam autism Centre
Islamabad
Rahim Hussain
About this study
Official title: Additional Effects of Vestibulo-Ocular Reflex Exercises to Improve Balance and Reduce Stimming in Adolescents With Autism Spectrum Disorder.
Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy.
Read the detailed description
Stimming behaviors and balance deficits 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 and reduce stimming behaviors. Although, Previous studies have recommended that Balance and stimming are directly related and that vestibular dysfunction plays a huge role in frequency of stereotyped stimming behaviors. The aim of the study is to investigate the effects of Vestibulo Ocular reflex exercises on balance and frequency of stimming. This study will also influence how a physical therapist can improve quality of life of an individual with autism by reducing their stimming behavior. Earlier studies also mentioned that Vestibular ocular reflex is affected in kids with autism. Hence this study can play an important role in determining the direct connection between these behaviors, Vestibular ocular reflex and balance.
- Conditions
- Autism Spectrum Disorder
- Being tested
- conventional treatment, experimental treatment
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional treatmentOther
conventional treatment with Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage
experimental treatmentOther
1 being a fixation point and phase 2 including head and eye movements
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Conventional treatment group will receive Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage) for 4 days a week for 6 weeks Receives: Other: conventional treatment |
| Experimental treatment | Experimental | the Vestibulo ocular reflex exercises added with conventional treatment will be given to the second group. Vestibulo-ocular reflex exercises will be performed in phases with phase 1 being a fixation point and phase 2 including head and eye movements. Vestibulo ocular reflex exercises will be started from a 5-minute duration and gradually increased to 60 minutes duration Receives: Other: experimental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant behavior checklist
Widely used to assess treatment effects in individuals with developmental disabilities. - Assess emotional and behavioral problems. -
Consists of 58 items categorized into 5 subscales:
social withdrawal, irritability, stereotypic behavior,
Measured: week 6
Berg Balance Scale (BBS)
It is often used to assess balance and mobility as well as identify people who are at risk of falling. 14 different balance-related tasks, including sitting, standing, and transferring, are included in the tool. Each factor is scored from 0 to 4, with 0 suggesting significant impairment and 4 denoting the patient's balance system operating normally
Measured: week 6
Repetitive Behavior Scale - Revised
Structured and standardized tool for assessing and characterizing repetitive behaviors in individuals with ASD. - Consists of six subscales: Stereotyped Behavior, Self- Injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted nterests. - Uses a Likert scale for rating frequency and intensity (0 to 3).
Measured: week 6
Functional Reach Test
A static balance test called the functional reach test is frequently used to evaluate a subject's level of balance when they are standing.The reach distance during this has been used as a measurement for determining fall risk
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start20 Mar 2024
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340139
- Sponsor's protocol ID
- Riphah/RCRAHS-ISB/REC/01742
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Vestibulo-Ocular Reflex Exercises to Improve Balance and Reduce Stimming in Adolescents With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06340139
- Acronym / sponsor ID
- Riphah/RCRAHS-ISB/REC/01742
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 1 Apr 2024 (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.
Autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, Communication and present with Rapid repetitive behaviors. Autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. Autism spectrum disorder can affect the quality of life of an individual to a severe extent. This disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. It is called a developmental disorder because it affects the growth. Milestones are often delayed in individuals with autism. Due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. Rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. Though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. Several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. Rehabilitation protocol of Autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy.
Detailed description
Stimming behaviors and balance deficits 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 and reduce stimming behaviors. Although, Previous studies have recommended that Balance and stimming are directly related and that vestibular dysfunction plays a huge role in frequency of stereotyped stimming behaviors. The aim of the study is to investigate the effects of Vestibulo Ocular reflex exercises on balance and frequency of stimming. This study will also influence how a physical therapist can improve quality of life of an individual with autism by reducing their stimming behavior. Earlier studies also mentioned that Vestibular ocular reflex is affected in kids with autism. Hence this study can play an important role in determining the direct connection between these behaviors, Vestibular ocular reflex and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Other: conventional treatmentConventional treatment group will receive Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage) for 4 days a week for 6 weeks |
| Experimental treatment | Experimental | Other: experimental treatmentthe Vestibulo ocular reflex exercises added with conventional treatment will be given to the second group. Vestibulo-ocular reflex exercises will be performed in phases with phase 1 being a fixation point and phase 2 including head and eye movements. Vestibulo ocular reflex exercises will be started from a 5-minute duration and gradually increased to 60 minutes duration |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-18 years
- Both male and female
- Diagnosed Autism Spectrum disorder.
- Visual and/or Vestibular stimming diagnosed by physician.
Key exclusion criteria (4 listed)
- Patients diagnosed with other neurological diseases
- Tumors or neoplasms
- Visual and auditory impairments
- Inability to respond to verbal command through verbal or non-verbal communication cues.
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 treatmentconventional treatment with Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage | Other | Conventional Treatment |
| experimental treatment1 being a fixation point and phase 2 including head and eye movements | Other | Experimental treatment |
Primary outcome
Aberrant behavior checklist
Time frame: week 6
Widely used to assess treatment effects in individuals with developmental disabilities. - Assess emotional and behavioral problems. - Consists of 58 items categorized into 5 subscales: social withdrawal, irritability, stereotypic behavior,
Berg Balance Scale (BBS)
Time frame: week 6
It is often used to assess balance and mobility as well as identify people who are at risk of falling. 14 different balance-related tasks, including sitting, standing, and transferring, are included in the tool. Each factor is scored from 0 to 4, with 0 suggesting significant impairment and 4 denoting the patient's balance system operating normally
Repetitive Behavior Scale - Revised
Time frame: week 6
Structured and standardized tool for assessing and characterizing repetitive behaviors in individuals with ASD. - Consists of six subscales: Stereotyped Behavior, Self- Injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted nterests. - Uses a Likert scale for rating frequency and intensity (0 to 3).
Functional Reach Test
Time frame: week 6
A static balance test called the functional reach test is frequently used to evaluate a subject's level of balance when they are standing.The reach distance during this has been used as a measurement for determining fall risk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ayesha Afridi, PhD* 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 experimental treatment 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 4 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahim Hussain, MS-NMPT (03408368837, rahimzzac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant behavior checklist (time frame: week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2024.