| CTRI Number |
CTRI/2023/08/056838 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Neurodynamic technique against positional release technique on calf muscle flexibility and performance in kho-kho players. |
|
Scientific Title of Study
|
Immediate effect of Neurodynamic technique versus Positional release technique on calf muscle flexibility and performance in Kho-Kho players- A Randomised Clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Ambadas Tandale |
| Designation |
Master of physiotherapy student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9096665128 |
| Fax |
|
| Email |
akashatandale134@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshwin Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9579076688 |
| Fax |
|
| Email |
drashwinkshirsagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAshwin Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9579076688 |
| Fax |
|
| Email |
drashwinkshirsagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy,Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM SCHOOL OF PHYSIOTHERAPY |
| Address |
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad |
| 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 |
| Dr Akash Ambadas Tandale |
MGM School of Physiotherapy sports OPD ,Aurangabad |
2nd floor,MGM School of Physiotherapy,C Building, N6 Cidco,Aurangabad
Aurangabad
MAHARASHTRA |
9096665128
akashatandale134@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Kho-Kho Players |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neurodynamic Technique |
The participants will be asked to maintain normal curvature of the head and spine and maintain both the hip and knee joints of the superior leg at 90-degree flexion in the supine position. The participant’s knee and thigh will be fixed by the therapist’s arms and torso to control the movement of the hip and knee joints. The participant’s foot will held using the opposite hand of the therapist. Subsequently, knee flexion, dorsiflexion, and eversion of the foot were performed on the subject in order to conduct the neurodynamic technique of the distal tibial nerve. To perform the neurodynamic technique of the proximal tibial nerve, knee extension, plantar flexion, and inversion of the foot were done simultaneously, dosage :- 10 times for a total of 10-15 minutes |
| Comparator Agent |
positional release technique |
For gastrocnemius: Subject will be in prone lying position with the knee flexed to 90 degree and the ankle plantarflexed. Therapist will apply a deep manual pressure over the palpated tender point and maintained it for 90 seconds. This procedure will be repeated 3 times.
Dosage : 90 seconds for 3 times
For soleus : Subject will be in prone lying position with the knee extended and the ankle plantar flexed. Therapist will apply a deep manual pressure over the palpated tender point and maintain it for 90 seconds. This procedure will be repeated 3 times.
Dosage : 90 seconds for 3 times
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Kho- Kho players between age of 18-25 years
Only male Kho - Kho players will be included
Participants who practice regularly since 3 years.
Participants having tightness of calf muscle. Participants having tender point over calf muscle. |
|
| ExclusionCriteria |
| Details |
Participants having history of calf injury within the past 1 year .
Previous ankle fracture and or surgery within last 12 or 6 months.
Recent ankle sprain and any lower limb injury since 1 year .
Players with any lower limb deformities.
Participants having wounds or cuts over plantar aspect .
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Weight bearing lunge test.
2. Pressure algometer.
3. The 5-10-5 test (pro agility or 20-yard shuttle run)
|
pre and post intervention (baseline)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/08/2023 |
| 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="1"
Months="0"
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
|
The Aim of the study is to find out immediate effect of neural mobilization contrast to positional release technique on calf muscle flexibility and performance in kho – kho players in which i will use three outcome measures 1. weight bearing lunge test 2. pressure algometer 3. 5-10-5 agility test |