| CTRI Number |
CTRI/2024/12/078768 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Stroboscopic Visual Training - Senaptec strobe glass] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on The Effect of Stroboscopic Visual Training in Collegiate Football Players. |
|
Scientific Title of Study
|
A study on the effect of stroboscopic visual training in collegiate football players |
| Trial Acronym |
effect of stroboscopic visual training in collegiate football players |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudesan Jothi |
| Designation |
Research Scholar |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences(SIMATS )-Deemed To Be University |
| Address |
E.V.R Periyar Salai (NH4 Highway),
Maduravoyal,Chennai -77,tamilnadu.
Saveetha Nagar, Thandalam, Chennai - 602 105. Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
8056272595 |
| Fax |
|
| Email |
sudeshanvetri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudesan Jothi |
| Designation |
Research Scholar and Assistant Professor |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences(SIMATS )-Deemed To Be University |
| Address |
E.V.R Periyar Salai (NH4 Highway),
Maduravoyal,Chennai -77,tamilnadu.
Saveetha Nagar, Thandalam, Chennai - 602 105. Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
8056272595 |
| Fax |
|
| Email |
sudeshanvetri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudesan Jothi |
| Designation |
Research Scholar and Assistant Professor |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences(SIMATS )-Deemed To Be University |
| Address |
E.V.R Periyar Salai (NH4 Highway),
Maduravoyal,Chennai -77,tamilnadu.
Saveetha Nagar, Thandalam, Chennai - 602 105. Tamil Nadu, India
Chennai
TAMIL NADU
600095
India |
| Phone |
8056272595 |
| Fax |
|
| Email |
sudeshanvetri@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.C.S. Avanced Medical Research Institute, NH-48, Velappanchavadi,chennai 600077 Tamil Nadu India |
|
|
Primary Sponsor
|
| Name |
ACS Avanced 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 |
| Sudesan J |
A.C.S.Medical College and Hospital |
A.C.S.Medical college and hospital, NH-4, Chennai 600077, Tamil Nadu India
Chennai
TAMIL NADU |
8056272596
sudeshanvetri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
football players
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of stroboscopic visual training in football players |
A study will be conducted to evaluate the effects of stroboscopic visual training on sensory-motor performance, with a comparator agent included for a comprehensive analysis. Reaction time, eye-hand coordination, balance, foot reaction time, and peripheral awareness will be measured in control, intervention, and comparator groups before and after an 8-week training period. The intervention group will undergo stroboscopic visual training using specialized eyewear, while the control group will engage in traditional training without visual occlusion. The comparator group will utilize an alternative training method, such as neurocognitive drills or non-stroboscopic visual aids, to assess its efficacy relative to the stroboscopic intervention. It is anticipated that the stroboscopic training group will demonstrate the greatest improvements, attributed to enhanced neural efficiency and predictive motor processing, while the comparator group is expected to show intermediate gains between the control and intervention groups.
|
| Intervention |
Stroboscopic visual training using Senaptec Strobe |
The intervention agent for this clinical trial will be the Senaptec Strobe eyewear, a specialized device designed for stroboscopic visual training. The eyewear intermittently disrupts visual input through controlled occlusion, compelling users to adapt by enhancing neural processing and motor planning. The training protocol using this intervention will target measurable improvements in reaction time, eye-hand coordination, balance, peripheral awareness, foot reaction time, and agility-quickness. The intervention group will engage in structured drills incorporating the Senaptec Strobe, progressively increasing strobe intensity over an 8-week period. This novel approach aims to optimize sensory-motor performance and will be rigorously evaluated against traditional training methods and alternative comparator agents. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
1.Footballers age ranging from 18 to 25 years.
2.Male football players.
3.Experience in playing football more than 2 years.
4.Footballers willing to come for follow up. |
|
| ExclusionCriteria |
| Details |
1.Ocular disease.
2.Color vision disorder.
3.Any neurological or cardiovascular conditions.
4.Athletes reporting epilepsy, migraine, or neurological or psychiatric disorders with any current systemic illness, strabismus, amblyopia.
5.BCVA less than 6/9 in either eye, history of eye trauma, intraocular surgery.
6.Use of any ocular or systemic drugs affecting accommodation or binocular vision.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved reaction time,agility,peripheral awareness, eye hand coordination, balance and foot reaction time in football players. |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroboscopic visual training improves fine motor control, neuromuscular coordination & cognitive processing function. |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 effect of 8 weeks of stroboscopic visual training between control group and experimental group in 98 participants conducted in ACS medical college and hospital India. The primary outcome is improved reaction time, agility, peripheral awareness, eye hand coordination, balance and neurocognitive skills in football players trained by stroboscopic visual training using strobe glasses. |