Vestibulo-Ocular Reflex for Balance and Stimming in Autism Spectrum Disorder

NCT06340139 | Recruiting DMC

• 1 other identifier: Riphah/RCRAHS-ISB/REC/01742
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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,

  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

  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).

  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

  week 6

Study Arms (2)

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

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

Other: experimental treatment

Interventions

conventional treatment OTHER

conventional treatment with Trampoline jumping, gym ball exercises, sensory diet (joint compressions, deep pressure, head massage

Conventional Treatment

experimental treatment OTHER

1 being a fixation point and phase 2 including head and eye movements

Experimental treatment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13-18 years
• Both male and female
• Diagnosed Autism Spectrum disorder.
• Visual and/or Vestibular stimming diagnosed by physician.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

zamam autism Centre

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ayesha Afridi, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahim Hussain, MS-NMPT

CONTACT

03408368837; rahimzzac@gmail.com

Ayesha Afridi, PhD*

CONTACT

03325962212; afridi.ayesha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: August 20, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)