| CTRI Number |
CTRI/2024/07/070680 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Eye muscle training boosts balance and foot pressure distribution for nearsighted college students |
|
Scientific Title of Study
|
Effect of Ocular Muscle Training on Foot Pressure Distribution and balance among college-going students with Myopia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-8698 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jay Shankar Choudhary |
| Designation |
MPT (Scholar) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 03, Neurology OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7879820924 |
| Fax |
|
| Email |
jayshankar.physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nidhi Sharma |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 03, Neurology OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9760835605 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Jay Shankar Choudhary |
| Designation |
MPT (Scholar) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no 03, Neurology OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7879820924 |
| Fax |
|
| Email |
jayshankar.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 03, Neurology OPD, Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation, Maharishi Markandeshwar (Deemed to be university), Mullana, Ambala, Haryana, India, 133207 |
|
|
Primary Sponsor
|
| Name |
Jay Shankar Choudhary |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy & Rehabilitation, Maharishi Markandeshwar (Deemed to be university), Mullana, Ambala, Haryana, India, 133207 |
| 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 Jay Shankar Choudhary |
Room no 03, Neurology OPD,Maharishi Markandeshwar institute of physiotherapy, |
Room no 03, Neurology OPD, Maharishi Markandeshwar institute of physiotherapy, Maharishi markandeshwar (deemed to be univercity), Mullana, Ambala, Haryana, India, 133207
Ambala
HARYANA |
7879820924
jayshankar.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Ocular muscle training |
Study invites myopic participants for voluntary ocular exercises 4 times/week for 4 weeks, with mid-assessment at 2 weeks. Final evaluation assesses balance and foot pressure distribution for analysis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosed case of myopia
-Age- 18-25 years
-Both male and female
-MMSE ≥ 24
-BBS score 35-44
|
|
| ExclusionCriteria |
| Details |
-Individual with hyperopia, emmetropia,
presbyopia.
-Any neurological disorder affecting eyesight, balance and foot pressure distribution
-Any musculoskeletal, metabolic and systematic illness affecting eyesight, balance and foot pressure distribution
-Any fracture, metal implant, wounds of lower limb
-Post surgical intervention
-Congenital deformities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
-Podia Scan
-Harris Mat
-Berg Balance Scale (BBS)
|
At baseline, after 2 weeks, and after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2024 |
| 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)
Modification(s)
|
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
|
Participants who have been diagnosed with myopia will be invited to participate in the study voluntarily, providing their consent. The study will commence with an initial baseline assessment to establish the starting point. Following this, participants will engage in a structured ocular exercise routine, scheduled four times a week over the course of four weeks. At the end of the initial 2-week period, a mid-assessment will take place to monitor progress. The ocular exercises will then continue for an additional 2 weeks. To conclude the study, a final assessment will be conducted to evaluate the effects of the exercise program on balance and foot pressure distribution. Subsequently, a thorough analysis will be carried out using the data collected throughout the study period. This analysis aims to provide insights into the potential benefits of ocular muscle training among college students with myopia. |