- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340139
Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder
March 25, 2024 updated by: Riphah International University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rahim Hussain, MS-NMPT
- Phone Number: 03408368837
- Email: rahimzzac@gmail.com
Study Contact Backup
- Name: Ayesha Afridi, PhD*
- Phone Number: 03325962212
- Email: afridi.ayesha@gmail.com
Study Locations
-
-
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Islamabad, Pakistan
- Recruiting
- zamam autism Centre
-
Contact:
- Rahim Hussain
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 13-18 years
- Both male and female
- Diagnosed Autism Spectrum disorder.
- Visual and/or Vestibular stimming diagnosed by physician.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Treatment
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
|
conventional treatment with Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage
|
Experimental: Experimental treatment
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
|
1 being a fixation point and phase 2 including head and eye movements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, |
week 6
|
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
|
week 6
|
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).
|
week 6
|
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
|
week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayesha Afridi, PhD*, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2024
Primary Completion (Estimated)
July 20, 2024
Study Completion (Estimated)
August 20, 2024
Study Registration Dates
First Submitted
March 25, 2024
First Submitted That Met QC Criteria
March 25, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/RCRAHS-ISB/REC/01742
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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