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CTRI Number  CTRI/2026/02/104958 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exercises for hyperactivity, balance and quality of life in autistic children 
Scientific Title of Study   Effectiveness of Vestibular and Proprioceptive exercises for hyperactivity, balance and quality of life in children with Autism Spectrum Disorder: A randomized controlled trial 
Trial Acronym  Hyperactivity in Autism Spectrum Disorder  
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan 
Designation  Student (neurology) 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Kankrola, Sector 87, Gurugram

Gurgaon
HARYANA
122505
India 
Phone  8882020388  
Fax    
Email  shrivastavmuskan622@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bharti Sharma  
Designation  Assistant professor  
Affiliation  Gurugram university  
Address  Department of Physiotherapy Gurugram university, Kankrola, sector 87, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9899381400  
Fax    
Email  bhartisharma@gurugramuniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Bharti Sharma  
Designation  Assistant professor  
Affiliation  Gurugram university  
Address  Department of Physiotherapy Gurugram university, Kankrola, sector 87, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9899381400  
Fax    
Email  bhartisharma@gurugramuniversity.ac.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Gurugram University  
Address  Department of Physiotherapy, Gurugram university, sector 87, kankrola, Gurugram, Haryana, India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Muskan PT  Sprouts speech and Occupational Therapy Centre   Lower Basement, 1798,BlockA, Greenwood city, Sector 45, Gurugram, Haryana, 122003
Gurgaon
HARYANA 
8882020388

shrivastavmuskan622@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Vestibular and proprioceptive exercises  4 weekS and 5 days a week 
Intervention  Group B General Physiotherapy Intervention  4 Weeks and 5 days a week 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Clinically confirmed autism spectrum disorder (ASD)- mild to moderate as per DSM-5
level 1 or 2 criteria.
2. Children can understand simple verbal commands.
3. Children exhibiting hyperactivity symptoms, confirmed by SNAP-IV parent rating scale
(hyperactivity subscale mean score more than 1.44) 
 
ExclusionCriteria 
Details  1. Patient with complete or uncorrected visual/auditory impairments .
2. History of any other neurological disorders (eg. cerebral palsy, uncontrolled epilepsy,
tethered spinal cord) which may affect participation in the study.
3. History of chronic medical and cardiopulmonary disorders (eg. uncontrolled asthma and
untreated cardiac condition).
4. Patient with severe ASD (level 3 severity). American Psychiatric Association.
5. History of any orthopaedic conditions (eg. Untreated fracture, and fracture or soft
tissue in
jury within past 6 months, club foot (treated or untreated). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Hyperactivity, Balance  Pre 1 week to 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life   Pre 1 week to 4 week  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   09/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Introduction 

Background 

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by persistent deficits in social communication and restricted, repetitive behaviors (American Psychiatric Association, 2013). A substantial proportion of children with ASD exhibit sensory processing dysfunction, particularly involving the vestibular and proprioceptive systems (Ben-Sasson et al., 2009; Tomcheck & Dunn, 2007). These sensory-motor impairments contribute to poor balance, motor incoordination, and behavioral dysregulation, often manifesting as hyperactivity (Jansiewicz et al., 2006; Minshew et al., 2004). Vestibular dysfunction affects postural control and arousal regulation, while proprioceptive deficits impair motor planning and body awareness, thereby limiting participation in daily activities and negatively influencing quality of life (Williams, 2019; Davis, 2018). Although conventional interventions primarily target behavioral and communication skills, emerging evidence suggests that vestibular and proprioceptive-based physiotherapy interventions may improve motor performance and reduce hyperactive behaviors. However, their combined effects on hyperactivity, balance, and quality of life require further systematic evaluation.


Procedure and Protocol 

The study will be conducted after the approval from Departmental Research Committee and the Institutional Ethical Committee of the University. A sample of 32 Autism Spectrum Disorder subjects who met the inclusion and exclusion criteria will be recruited. Their guardians were given a detailed explanation about the motive and procedure of the study. An informed consent was duly obtained from all the subject’s guardians who voluntarily agreed to participate in the study. Demographic details and pre-intervention assessment will be taken.
Group allocation:- Participants will be randomized into two groups using chit pattern.
Group A:- Interventional group (16 participants)
Group B:- Control group. (16 participants)

For conventional group:- 

Vestibular and Proprioceptive exercises 

Week 1 & 2:- 
Standing still with legs apart on both feet . 
Holding an object (toy stick) with legs apart. 
Trying to stand still with legs together. 
Holding an object (toy stick) with legs together. 
Standing up from sitting position on wobble board with the help of a physiotherapist. 
Dribbling a swiss ball with both hands while looking without looking at it. 
Jumping on a trampoline while holding the physiotherapist’s hand.
Trying to jump higher on a trampoline while holding the physiotherapist’s hand. 
Put rings from one end to another while walking on blocks placed closely. 
Walking on sensory pads. 
Rotational and linear swinging in a Svava swing. 
Sit to stand and vice versa while Rotational and linear swinging in a Svava swing
Applying whole body pressure with a Bobath ball after wrapping with a Pilates mat.
Put the rings from one place to another while walking on blocks. 
Put the rings back in holder from right to left side and vice versa while sitting on the Swiss ball.
Climbing on climbing board. 

Week 3&4 :- 
Trying to stand on one leg (separately for left and right legs). 
Trying to stand on a Bosu ball with both feet with the help of the physiotherapist. 
Standing up from sitting position without the help of physiotherapist. 
Trying to toss and catch a swiss ball while jumping on a trampoline. 
Put the rings from one end to another while walking on blocks place slightly apart . 
Animal walking while crossing the hurdles. 
Walking on sensory pads spaced further apart than in previous weeks. 
Trying to climb higher while holding the physiotherapist’s hand with one hand. 
Climbing a climbing board and put soft balls on top part. 
Put soft balls in basket while Rotational and linear swinging in a Svava swing Applying whole body pressure with a Bobath ball after wrapping with a Pilates mat.


For control group:

General physiotherapy intervention
The program included structured exercises targeting both fine and gross motor skills.

WEEK 1–2
(Basic Functional Activities)
Simple walking on flat surface (short distance).
Slow stepping forward–backward.
Sit-to-stand with support.
Gentle trunk rotation & side reaching.
Soft ball rolling to therapist (10–12 repetitions).
Light arm and leg mobility tasks with slow pace.
Simple stepping over line drawn on floor.
All tasks done slowly to ensure familiarization.

WEEK 3–4
(Moderate Progression)
Increase repetitions of all tasks by 20–30%.
Introduce mildly longer walking pathway.
Add soft-surface stepping (soft blocks/cushion).
Controlled stepping over small obstacles (1–2 cm height).
Walking with direction changes.
Introduce low-resistance theraband for simple arm and leg movements.
Replace ball rolling with throwing/catching (short distance).
Increase stepping speed slightly while maintaining safety.
Longer walking paths with 2–3 obstacles.
Walking fast with head-turns (left–right).
Stepping on and off on blocks (height increases).
Ball bouncing or catching while standing.
Introduce slightly challenging step patterns (side–step, cross step).
Improve coordination using simple dual-task activities (e.g., holding ball while walking).
Mostafa, M. et. al. (2014).Anderson-Hanley et. al. (2011). Pan, C.-Y. (2008),Fournier, K. A., et al. (2010).

A post intervention assessment was carried out at the end of 4 weeks (20th session) with the repeated outcome measures of both groups (intervention and control).


Outcome measures 

VADPRS 
The VADPRS was used as the primary outcome measure, specifically focusing on the Hyperactive/Impulsive subscale (questions 10–18). This subscale was selected due to its relevance in capturing hyperactivity-related behaviors in children with ASD, despite not being explicitly validated for this population (Wolraich, 2013). Each item is rated on a scale from 0 (never) to 3 (very often), with higher scores indicating greater symptom severity (Wolraich, 2003; Küçük Dogaroglu et al., 2012).
It is a parent rated scale so all the questions will be asked from subject’s mother or father and according to their answer we will score each question.

PBS 
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. (Franjoine MR, et. al.).

ASQoL
Nine autism-specific (ASQoL) items are listed. Three of the items are negatively phrased, hence are reverse-scored. One of the items was intended as a ‘global’ QoL item about autistic identity. The WHOQoL measures along with the newly developed ASQoL show promise for use with autistic people in clinical settings to elucidate some of the challenging issues they may be experiencing in their lives. (Helen mcConachie et. al. 2017). 
It is a also parent rated scale so all the questions will be asked from subject’s mother or father and according to their answer we will score each question.


 
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