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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: conventional treatment
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
Other: experimental treatment
1 being a fixation point and phase 2 including head and eye movements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings