| CTRI Number |
CTRI/2024/09/074464 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| 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
|
A study to see which method works better for relieving tight hamstrings- the Hold Relax technique or the Neurodynamic Sliding technique. |
|
Scientific Title of Study
|
A study to compare the effectiveness of proprioceptive neuromuscular facilitation (Hold Relax) Vs neurodynamic sliding technique on hamstring tightness - a randomized controlled 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 |
Joji Jayaraj |
| Designation |
PG student |
| Affiliation |
Narayana Hrudayalaya Institute Of Physiotherapy |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Narayana Hrudayalaya International wing physiotherapy center ,room no- 104.
Bangalore
KARNATAKA
560099
India |
| Phone |
9497413051 |
| Fax |
|
| Email |
jojijayaraj02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Smruti Swagatika Dash |
| Designation |
Professor |
| Affiliation |
Narayana Hrudayalaya Institute Of Physiotherapy |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Narayana Hrudayalaya International wing physiotherapy center ,room no-104
Bangalore
KARNATAKA
560099
India |
| Phone |
9448552026 |
| Fax |
|
| Email |
ssdashpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joji Jayaraj |
| Designation |
PG student |
| Affiliation |
Narayana Hrudayalaya Institute Of Physiotherapy |
| Address |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Narayana Hrudayalaya International wing physiotherapy center ,room no-104
Bangalore
KARNATAKA
560099
India |
| Phone |
9497413051 |
| Fax |
|
| Email |
jojijayaraj02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD - Narayana Hrudayalaya International wing Physiotherapy center room no 104.
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [(.)] |
|
|
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 Joji Jayaraj |
Narayana Hrudayalaya Institute Of Physiotherapy |
258/A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Narayana Hrudayalaya International wing physiotherapy center,room no-104
Bangalore
KARNATAKA |
9497413051
jojijayaraj02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Hrudayalaya Academic Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neurodynamic sliding technique |
This group will undergo neurodynamic sliding technique for the hamstring. The technique will begin with the person lying on their back with both legs extended. Lift the affected leg slightly off the ground to create tension in the hamstring and nerve. While keeping the leg raised , dorsiflex the foot, which helps to tension the sciatic nerve. Slowly extend the knee of the raised leg , maintaining dorsiflexion of the foot. This movement helps to further tension the nerve. With the knee extended, gently flex the hip by bringing the raised leg towards the chest while maintaining dorsiflexion of the foot. This movement should create a sliding sensation along the back of the leg. Slowly reverse the movement, bringing the leg back to the initial position with the knee extended and the food dorsiflexed. Perform the neurodynamic sliding movement 2-3 times, ensuring it is done slowly and gently to avoid causing discomfort. After completing the repetitions, allow the leg to rest in a neutral position to relax the tissues. This should be done for 8 weeks.
|
| Intervention |
Proprioceptive neuromuscular facilitation (Hold Relax) |
This group will undergo Proprioceptive neuromuscular facilitation (Hold Relax) technique for which will be ‘hands-on’ therapy to induce muscle stretching and relaxation. It will be a rehabilitative therapeutic option for hamstring tightness with the aim to restore normal mobility. PNF technique will be applied by positioning the person lying on their back with the leg extended straight on the ground. Gently raise the leg to the point of mild discomfort, stretching the hamstring muscle. The person then contracts the muscle by pushing against the resistance provided by the therapist’s hand for about 7-10 seconds. This contraction should be maximum but comfortable. After the contraction , the person relaxes the muscle completely while the therapist maintains the stretch for around 15-30 seconds. This process is typically repeated 2-3 times , gradually increasing the stretch each time. After the final repetition, allow the muscle to relax complexly before slowly lowering the leg back to the starting position. This should be done for 8 weeks. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-25yrs
With normal joint mobility
AKE(Active knee extension) range between 90°- 125°
|
|
| ExclusionCriteria |
| Details |
Subjects with recent fractures
Low joint mobility
Spinal deformity
Hamstring strain
Metabolic disease
Hamstring tear
Rheumatoid arthritis
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Active Knee Extension Test (AKE) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
10/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
AIMS: To find out the effectiveness of PNF(hold relax) technique in comparison with neurodynamic sliding technique on improving flexibility in patients with hamstring tightness.
PRIMARY OBJECTIVE: To compare the effects of PNF(hold relax) technique in comparison with neurodynamic sliding technique on improving flexibility in patients with hamstring tightness. SECONDARY OBJECTIVE: To evaluate PNF(Hold Relax) technique and the neurodynamic sliding are improving range of motion and flexibility in hamstring tightness.
Hypothesis:
Null Hypothesis [H0]: •There will be no significant effect of PNF(hold relax) technique on flexibility in individuals with hamstring tightness. •There will be no significant effect of neurodynamic sliding technique on flexibility in individuals with hamstring tightness. •There will be no significant difference between PNF(hold relax) and neurodynamic sliding technique on flexibility in individuals with hamstring tightness. Alternate Hypothesis [H1]: •There will be a significant effect of PNF(hold relax) technique on flexibility in individuals with hamstring tightness. •There will be a significant effect of neurodynamic sliding technique on flexibility in individuals with hamstring tightness.
•There will be significant differences between PNF(hold relax) and neurodynamic sliding technique on flexibility in patients with hamstring tightness.
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