| CTRI Number |
CTRI/2024/04/065996 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare the effects of psychomotor rehabilitation vs tai chi exercises on balance and fall risk in children with autism spectrum disorder |
|
Scientific Title of Study
|
A Comparative Study on Effect of Psychomotor Rehabilitation versus Tai Chi exercises on Postural Control and Risk Of Fall 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 |
Shradha Vadiraj Chanageri |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D Y Patil College of Physiotherapy |
| Address |
Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor,
Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri,
Pune Maharashtra 411018 India
B-301, 3rd floor, Galaxy Avenue Apartment, sector 11, Moshi high street link road, Chikhali Pradhikaran 411019
Pune
MAHARASHTRA
411018
India |
| Phone |
7972974761 |
| Fax |
|
| Email |
shradha.chanageri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhi Shah |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy |
| Address |
Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor,
Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri,
Pune Maharashtra 411018 India
B-304,Rajshree Sunandha
Society,Park Royal Road,Shivrajnagar4, Kokane chowk,
Rajarani,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8149385218 |
| Fax |
|
| Email |
vidhivarun13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhi Shah |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D Y Patil College of Physiotherapy |
| Address |
Department of Neuropediatric Physical therapy, 2nd cabin, 3rd floor,
Dr. D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri,
Pune Maharashtra 411018 India
B-304,Rajshree Sunandha
Society,Park Royal Road,Shivrajnagar4, Kokane chowk,
Rajarani,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8149385218 |
| Fax |
|
| Email |
vidhivarun13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D Y Patil college of physiotherapy OPD, Sant Tukaram Nagar, Pimpri, Pune Maharashtra
411018 |
|
|
Primary Sponsor
|
| Name |
Shradha Vadiraj Chanageri |
| Address |
B-301, 3rd floor, Galaxy Avenue Apartment, sector 11, Moshi high street link road, Chikhali Pradhikaran - 411019 |
| 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 |
| Shradha Vadiraj Chanageri |
Dr. D Y Patil college of physiotherapy OPD |
Dr. D Y Patil college of
physiotherapy, Sant
Tukaram Nagar, Pimpri,
Pune Maharashtra
411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7972974761
shradha.chanageri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth |
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: F848||Other pervasive developmental disorders, (4) ICD-10 Condition: F849||Pervasive developmental disorder,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Psychomotor Exercises |
This is a 6 weeks intervention with 3 sessions per week.
A total of 18 sessions will be done. |
| Intervention |
Tai Chi Exercises |
This is a 6 weeks intervention with 3 sessions per week.
A total of 18 sessions will be done. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with diagnosis of Autism Spectrum disorder by pediatrician and clinical psychologist.
2. Children aged between 8 – 12 years of age with ASD.
3. Children who have the ability to understand and communicate and to perform motor tasks.
4. IQ level more than or equal to 70 on Wechsler Intelligence Scale for Children.(14)
5. Normal visual and auditory acuity confirmed by medical records.
6. A score between 30 and 36.5 on Childhood Autism Rating Scale indicating mild to moderate autism.
7. A scale score of below average on the subset of balance of Bruininks-Oseretsky Test of Motor Proficiency- 2nd edition.
8. Ability to walk at least 10 m independently and ability to sit and stand independently with or without walking aids or orthoses.
|
|
| ExclusionCriteria |
| Details |
1. Children with neurological condition coexisting with Autism Spectrum Disorder
2. Any co morbid orthopaedic conditions.
3. A score above 36.5 on Childhood Autism Rating Scale indicating severe autism
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Bruininks-Oseretsky Test of Motor Proficiency-
2nd Edition
2.Timed Up and Go Test |
ONE, PRE-DATA WILL BE COLLECTED AND
THEN FINAL POST-INTERVENTION
READINGS WILL BE TAKEN AFTER 18
SESSIONS COMPLETION. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Approximately 80% of
children diagnosed with ASD exhibit challenges related to motor coordination,
including deficits in both gross and fine motor skills, clumsiness, reduced
ankle movement, and an abnormal gait pattern (such as walking on tiptoes).These individuals often experience difficulties with both static and
dynamic postural control, with up to 83% struggling to perform age-appropriate
motor skills.
Tai Chi Chuan training concentrates on enhancing balance capability,
proprioceptive functions, and body awareness, potentially contributing to
improvements in cognition, balance, and behavioral challenges in individuals
with autism. The key components of a Tai Chi Chuan schedule encompass slow
motions, gait training, repetitive sit-to-stand movements, balance exercises,
relaxation, mind stimulation tasks, and sensory-motor exercises.
Psychomotor rehabilitation seeks to foster integration between cognition
(psycho) and movement (motor) through targeted activities. Core areas include
body awareness, spatial awareness, directional awareness, temporal awareness,
and rhythm. Consequently, the training program involves a combination of
balancing activities, cognitive stimulation games, fine and gross motor
exercises, as well as jumping and sensory integration activities. |