| CTRI Number |
CTRI/2025/02/079919 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Structured Exercise Training in Adolescent Short Track Roller Skaters with Shin Splint |
|
Scientific Title of Study
|
Effect of Structured Exercise Training Program on Speed, Lower Limb Power, Dynamic Balance and Pain in Adolescent Short Track Roller Skaters with Shin Splint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikhar Singh Thakur |
| Designation |
MPT Student |
| Affiliation |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana |
| Address |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8871158286 |
| Fax |
|
| Email |
physioshikhar95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Anand |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana |
| Address |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9810240409 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Anand |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana |
| Address |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9810240409 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Physiotherapy Research Lab Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana India |
|
|
Primary Sponsor
|
| Name |
Shikhar Singh Thakur |
| Address |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana |
| 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 |
| Shikhar Singh Thakur |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University |
Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University Gurugram Haryana
Gurgaon
HARYANA |
8871158286
physioshikhar95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Shin Splint |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical education and routine warm up and cool down exercise |
physical awareness education class, dynamic stretching, schedule regular rest days, water intake and balanced diet |
| Intervention |
Structured Exercise Training Program |
Stretching exercises, balance exercises, strengthening exercise, speed and agility exercise , plyometric exercises will be delivered for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
atraumatic shin pain
district level skaters with minimum 2 years of experience |
|
| ExclusionCriteria |
| Details |
Underlying systematic disease
History of any lower limb surgery
Neurological disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
pre-intervention & post-intervention after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Countermovement Jump Height
Directional speed test
Y-Balance Test |
pre-intervention & post-intervention after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/02/2025 |
| 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="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
|
Ethical approval of this study will taken from the institutional ethical committee of Faculty of Physiotherapy Shree Guru Gobind Singh Tricentenary University. Study will be done in accordance with Helsinki Declaration Revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017.
This study compares the effect of structured exercise training program on pain, dynamic balance, speed and lower limb power in adolescent short track roller skaters. Treatment will be given for 6 weeks and between and within group Comparison will be done. |