| CTRI Number |
CTRI/2023/07/054957 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Light trainer] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative study on reaction time and neurocognitive training in cricketers using light trainer system |
|
Scientific Title of Study
|
A study on reaction time and neurocognitive training in cricketers using light trainer system |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPIKA DHNAU SHREE A |
| Designation |
INTERN |
| Affiliation |
DR. M.G.R Educational and research institute |
| Address |
Dr.M.G.R Educational and research institute,
Allied health sciences,
Department of optometry,
NH-48,VELAPPANCHAVADI,
Chennai
600077
Tamilnadu
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9150565318 |
| Fax |
|
| Email |
deepikadhanu1801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUDESAN J |
| Designation |
ASSITANT PROFESSOR |
| Affiliation |
DR. M.G.R Educational and research institute |
| Address |
Dr.M.G.R Educational and research institute,
Faculty of Allied health sciences,
Department of optometry,
NH-48,VELAPPANCHAVADI,
Chennai
600077
Tamilnadu
India
Chennai
TAMIL NADU
600077
India |
| Phone |
8056272596 |
| Fax |
|
| Email |
sudesan.opto@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
SUDESAN J |
| Designation |
ASSITANT PROFESSOR |
| Affiliation |
DR. M.G.R Educational and research institute |
| Address |
Dr.M.G.R Educational and research institute,
Faculty of Allied health sciences,
Department of optometry,
NH-48,VELAPPANCHAVADI,
Chennai
600077
Tamilnadu
India
Chennai
TAMIL NADU
600077
India |
| Phone |
8056272596 |
| Fax |
|
| Email |
sudesan.opto@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| ACS ADVANCED MEDICAL RESERACH INSTITUTE, Service road,maduravoyal,adayalampattu,tamilnadu 95 |
|
|
Primary Sponsor
|
| Name |
ACS Advanced Medical Research Institute |
| Address |
DR.M.G.R. Educational and research institute,maduravoyal,chennai-95 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSUDESAN J |
ACS MEDICAL COLLEGE AND HOSPITAL |
Acs Medical College and hospital,
NH-48,VELAPPANCHAVADI,CHENNAI 600077, TAMILNADU,INDIA.
Chennai
TAMIL NADU |
8056272596
sudesan.opto@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INTERVENTION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Light trainer exercise system |
Reaction time will be Measured using light trainer system.
T drill exercise performed 3 days a week for total of 8 weeks using light trainer system |
| Comparator Agent |
Light trainer exercise system between cricketers reaction time |
Reaction time is measured in both control and intervention group before and after 3 days a week for 8 weeks of training using light trainer system |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Cricket players without any prior episodes of concussion.
Cricket players with normal color vision
Cricket players with normal motor balance
Willing to return for required follow up |
|
| ExclusionCriteria |
| Details |
Subjects having visual impairment and abnormal vestibular, neurological conditions like cerebral palsy are not included in this study.
Subjects with any Ocular disorders and Oculomotor Palsy are not included in this study.
Subjects with any current systematic illness is not included.
Subjects with strabismus, amblyopia
BCVA less than 6/9 in either eye, history of eye trauma,
History of intraocular surgery, any pathologic or systemic disease affecting accommodation or binocular vision
In this study, use of any ocular or systemic drugs affecting accommodation or binocular vision.
History of recent brain injuries |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVES REACTION TIME IN CRICKET PLAYERS |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will be the first study with cricket players to improve skills with the Light Trainerâ„¢ system.
By implementing Light Trainerâ„¢ system early detection & training can be given for speed & reaction time.
It can be used as concussion screening tool in cricket players.
Light Trainerâ„¢ used to train peripheral vision, fine motor control and coordination neuromuscular and cognitive processing function. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
26/07/2023 |
| 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 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
|
This is a randomized clinical trial comparing the reaction time and neurocognitive skills in cricketers using light trainer system between intervention group and control group for 8 weeks in 34 participants that trial will be conducted in ACS medical college and hospital in India.The primary outcome will be improved reaction time and neurocognitive skills in cricketers trained by light trainer system.
|