CTRI Number |
CTRI/2025/06/089037 [Registered on: 18/06/2025] Trial Registered Prospectively |
Last Modified On: |
17/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Other |
Public Title of Study
|
Acute effect of neurodynamic moblisation technique |
Scientific Title of Study
|
Acute Effect of Active Neurodynamic Slider and Tensioner Mobilisation Technique on Hamstring Flexibility and Lower Limb Power in male Recreational Football Players |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prabhat kumar |
Designation |
MPT student |
Affiliation |
Delhi pharmaceutical sciences and research university |
Address |
Delhi Pharmaceutical Sciences and Research University,School of Physiotherapy,Sector-3, Pushp, Vihar, M.B. Road New Delhi 110017
South DELHI
India
South DELHI 110017 India |
Phone |
9582974141 |
Fax |
|
Email |
prakumar103@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prabhat kumar |
Designation |
MPT student |
Affiliation |
Delhi pharmaceutical sciences and research university |
Address |
Delhi Pharmaceutical Sciences and Research University,School of Physiotherapy,Sector-3, Pushp, Vihar, M.B. Road New Delhi 110017
South DELHI
India
South DELHI 110017 India |
Phone |
9582974141 |
Fax |
|
Email |
prakumar103@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jitender munjal |
Designation |
Assistant professor |
Affiliation |
Delhi pharmaceutical sciences and research university |
Address |
Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy, Sector-3, pushp vihar, M.B road new delhi 110017 south delhi india
South DELHI 1100017 India |
Phone |
9899800664 |
Fax |
|
Email |
jitendermunjal80@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Delhi pharmaceutical sciences and research university |
Address |
Delhi Pharmaceutical
Sciences and Research
University, School of
Physiotherapy,Sector-3,
Pushp Vihar, M.B.
Road New Delhi
110017
South
DELHI |
Type of Sponsor |
Research institution |
|
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 |
Prabhat Kumar |
Delhi pharmaceutical sciences and research university |
Room no. 603,School of Physiotherapy , Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy,Sector-3, Pushp Vihar, M.B. Road New Delhi 110017 South DELHI India South DELHI |
9582974141
prakumar103@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
healthy |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control group |
The control group will continue their daily routine activity and Physical activity. |
Intervention |
Neurodynamic slider and tensioner mobilisation technique |
Neurodynamic slider group protocol- A familiarisation session will be conducted for all the participants. Total duration= 9minutes for both legs. Total sets will be 3 for both the legs (60 sec in one set) = 3x60 for right leg and 3x60 for left leg. Repetitions in each set will be 30 reps i.e. 1 rep =2sec. rest period between sets= 30 sec between each set.
Neurodynamic tensioner group protocol-A familiarisation session will be conducted for all the participants. Total duration =9minutes for both legs. Total sets will be 3 for both the legs (60 sec in one set) = 3x60 for right leg and 3x60 for left leg. Repetitions in each set will be 30 reps i.e. 1 rep =2sec. rest period between sets= 30 sec between each set.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
26.00 Year(s) |
Gender |
Male |
Details |
1.Subjects of the Age- 18-26 years
2. BMI- Normal-18.5-24.9 kg/m2
3.Male College going students Competing in college and inter-college competitions (recreational football player), who are not performing any regular soccer-specific training for the last two years.
4. Participants with knee extension angle less than 70° will be included.
5. Subjects who fully understood the study and decided to participate of their own free will and agreed with the written consent document will be included in the study. |
|
ExclusionCriteria |
Details |
Subjects with any history/diagnosed case of-
1.Lower extremity injuries that may have limited their performance or necessitated medical attention in last 12 months
2.Individuals who have had any lower limb or lumbar spine surgery in last six months.
3. Recent hamstring strain or injury.
4.Low back pain in the last 6 months or leg pain.
5. Individuals who are currently enrolled in other flexibility programs or performing regular lower extremity muscle stretching exercises will be excluded from the study.
6. History of neck trauma (whiplash), Neck pain symptoms
7.Any diagnosis of a herniated vertebral disk
8. National level athletes will be excluded.
9.Diabetes mellitus/Hypertension
10.Neuro-physiological disorder
11. Orthopedic disorders
12.medical/systemic/ophthalmologic conditions
13. Acute or chronic respiratory disorder
14.Cardio-vascular disorder
15.Any regular medication, which can affect the outcome of the study.
16. Unwilling to participate. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Hamstring flexibility:Active Knee Extension (AKE) test.
Lower limb power and jump
height:Sargent Jump Test.
|
Baseline
Post -immediately after intervention and 60 minutes after intervention. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Score of International physical activity questionnaire (IPAQ)- Short form |
Baseline
No post readings |
|
Target Sample Size
|
Total Sample Size="81" Sample Size from India="81"
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
|
N/A |
Date of First Enrollment (India)
|
30/06/2025 |
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="0" Months="4" 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
|
Neurodynamic mobilisation is a manual technique that applies
force to neural tissues through posture and multi-joint movements, facilitating
the sliding of neural structures relative to surrounding tissues . This
technique is believed to reduce neural mechanosensitivity through
neurodynamic sliding methods, the use of neurodynamic sliders (NS) and
tensioners (NT) can help alleviate abnormal mechanosensitivity, producing excursion and strain on
the neural tissues.The participants will be formally invited to join the study. Before their involvement, all participants will undergo a general assessment, which will include collecting demographic information, anthropometric data (weight in kg, height in cm², and BMI in kg/m²), IPAQ questionnaire, educational background, and details regarding any current medications they are taking.After explaining the significance, benefits, and purpose of the study in either Hindi or English, informed consent will be obtained from the participants. To ensure fairness, all the selected participants will be randomly assigned to either Group A (NDS slider group) or Group B (NDS tensioner group) or Group C (control group). Prior to any interventions, baseline measurements of all the subjects will be taken, and will be subjected to Active knee extension test, Sargent jump test and the scores will be noted on the Data collection form. • Following the intervention, assessments will be conducted for all subjects at T1(immediately after intervention) and T2 (60 min after intervention). Score from Active knee extension test and Sargent jump test will be collected and analyzed. |