| CTRI Number |
CTRI/2024/04/066467 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of perceptual motor exercises on fine motor skills in autism spectrum disorder children. |
|
Scientific Title of Study
|
Effect Of perceptual motor exercises on dexterity fine motor integration and precision in children With autism spectrum disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhargavi Sukey |
| Designation |
PG Student |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Department of Neuropediatric Physical Therapy ,3rd floor,Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune , Maharastra
Pune
MAHARASHTRA
411018
India |
| Phone |
8237625581 |
| Fax |
|
| Email |
bhargavi.sukey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Palekar |
| Designation |
Associate professor |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Department of Neuropediatric Physical Therapy ,3rd floor , Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9689481499 |
| Fax |
|
| Email |
pramod.palekar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Palekar |
| Designation |
Associate professor |
| Affiliation |
Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune |
| Address |
Department of Neuropediatric Physical Therapy ,3rd floor , Dr. D.Y Patil College of Physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9689481499 |
| Fax |
|
| Email |
pramod.palekar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Bhargavi Sukey |
| Dr D Y Patil College Of physiotherapy OPD ,ground floor, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Bhargavi Sukey |
| Address |
Dr. D.Y Patil College Of Physiotherapy, Pimpri, Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Palekar |
Dr. D.Y Patil College of Physiotherapy |
Dr. D.Y Patil College of Physiotherapy OPD,Ground Floor, Pediatric section, Pimpri ,Pune
Pune
MAHARASHTRA |
9689481499
pramod.palekar@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. D.Y Patil College of Physiotherapy,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F845||Aspergers syndrome, (2) ICD-10 Condition: F840||Autistic disorder, (3) ICD-10 Condition: F843||Other childhood disintegrative disorder, (4) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Perceptual Motor exercises. |
Perceptual motor exercises are group of cognitively challenging exercises that collaborates sensory and motor systems. The following intervention program will be given for 4 weeks. (16 sessions, 4 sessions per week)
These exercises include -
TEXTURE
a. Make a set of tactile cards with surfaces varying from rough to soft.
b. Common objects are placed in a bag and the child is asked to feel the objects
c. Objects should be 2 dimensional and 3 dimensional
THERAPUTTY ACTIVITIES
a. Copy shapes made by the instructor.
b. Make various shapes and line then with grains.
c. Remove the grains one by one.
BUTTON ACTIVITY
a. Scatter the buttons the plain surface. Have the child sort the buttons out.
b. Repeat the same activity on a surface that provides more distraction
c. Pick up the buttons and drop in a container with small opening.
d. Repeat the same activity with a container that has narrower opening
BLOCK ACTIVITY
a. Hand the blocks to the child from various angles and positions so that they must look at and reach for them
b. Stack blocks broad to narrow
c. Stack blocks according to the same color or shape.
GEOBOARD ACTIVITY
a. Ask the participants to create make designs using rubber bands i.e. various shapes.
b. Make him copy designs made by the therapist.
PUZZLE ACTIVITY
a. Try to put pieces of puzzle together.
PEGBOARD ACTIVITY
a. Instruct the participants to precisely place the peg in the pegboard.
b. Instruct the child to make horizontal lines, vertical lines
c. Have the child copy more complicated designs
STRING BEAD ACTIVITY
a. Instruct the participant to put beads through the string.
b. Bead according to different colors.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with diagnosis of Autism Spectrum disorder.
2.Children aged between 6 – 12 years of age.
3.IQ level more than or equal to 80 - 110 on 4.Wechsler Intelligence Scale for Children.
5.Normal visual field, acuity and colour vision and auditory acuity confirmed by medical records.Â
6.Functional level 1 or 2 on The Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders.
7.A scale score of below average on all the 3 subsets of fine motor skills of Bruininks-Oseretsky Test of Motor Proficiency- 2nd edition.
|
|
| ExclusionCriteria |
| Details |
1.Children with neurological condition coexisting with Autism Spectrum Disorder.
2.Any co morbid orthopedic conditions.
3.Functional level 3 on The Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bruininks-Oseretsky Test of Motor Proficiency- 2nd Edition
|
Pre 0th week
Post 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Literature reveals that ASD has core deficits that are stereotypical
behaviors, impaired communication, impaired social interaction and motor
impairments.
Motor impairment is
considered a co morbid symptom of ASD. There is substantial risk for motor
impairment or Developmental coordination disorder in the majority of children
with ASD. The relative risk for motor impairment was 22.2 times greater in
children with ASD compared to the general population. Children with ASD did not
outgrow their motor impairments and continue to present with a risk for DCD
even into adolescence. Motor deficits are under-recognized, under-diagnosed,
and under-treated in children with ASD. Addressing fine motor skills, encompassing dexterity, fine motor
integration, and precision is vital as it directly impacts an individual’s
overall quality of life and functional independence. These skills are the
building blocks of daily living, enabling individuals to perform essential
tasks independently.
Visual, vestibular, and tactile sensory dysfunctions all seem to
have an effect on fine motor abilities, with tactile dysfunction having the
most of an effect. Perceptual motor development is closely linked to fine motor
development. The sensory systems (visual, auditory, and tactile) collaborate
with the motor system to execute increasingly complicated tasks. In view of this, this study attempts to explore the effectiveness of
perceptual-motor training dexterity, fine motor integration and precision in
children of ASD. |