| CTRI Number |
CTRI/2022/02/039977 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effects of Muscle energy technique and Neurodynamic sliding on flexibility of hamstring muscle and balance among athletes. |
|
Scientific Title of Study
|
Comparative effectiveness of Muscle energy technique versus Neurodynamic sliding on hamstring flexibility and balance among athletes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RICHA MAHAJAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GD GOENKA UNIVERSITY |
| Address |
Room no. B-315, B-block, 3rd floor, Department of Physiotherapy, School of Medical and Allied Sciences, GD Goenka University, Sohna - Gurgaon Rd, Sohna, Haryana 122103
Gurgaon
HARYANA
Gurgaon
HARYANA
122103
India |
| Phone |
9818221585 |
| Fax |
|
| Email |
rch_mhjn@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ELINA DEWANJI SEN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GD GOENKA UNIVERSITY |
| Address |
Room no. B-315, B-block, 3rd floor, Department of Physiotherapy, School of Medical and Allied Sciences, GD Goenka University, Sohna - Gurgaon Rd, Sohna, Haryana 122103
Gurgaon
HARYANA
Gurgaon
HARYANA
122103
India |
| Phone |
9811641781 |
| Fax |
|
| Email |
elina.dewanji@gdgu.org |
|
Details of Contact Person
Public Query
|
| Name |
RICHA MAHAJAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GD GOENKA UNIVERSITY |
| Address |
Room no. B-315, B-block, 3rd floor, Department of Physiotherapy, School of Medical and Allied Sciences, GD Goenka University, Sohna - Gurgaon Rd, Sohna, Haryana 122103
Gurgaon
HARYANA
Gurgaon
HARYANA
122103
India |
| Phone |
9818221585 |
| Fax |
|
| Email |
rch_mhjn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GD GOENKA UNIVERSITY, GURGAON, INDIA |
|
|
Primary Sponsor
|
| Name |
RICHA MAHAJAN |
| Address |
Room no. B-315, B-block, 3rd floor, Department of Physiotherapy, School of Medical and Allied Sciences, GD Goenka University, Sohna - Gurgaon Rd, Sohna, Gurgaon HARYANA-122103, India |
| 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 |
| RICHA MAHAJAN |
GD GOENKA UNIVERSITY |
Room no. B-315, B-block, 3rd floor, Department of Physiotherapy, School of Medical and Allied Sciences, GD Goenka University, Sohna - Gurgaon Rd, Sohna, Haryana 122103
Gurgaon
HARYANA |
9818221585
rch_mhjn@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIAN FERTILITY SOCIETY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ATHLETE WITH UNILATERAL HAMSTRING TIGHTNESS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Moist heat pack
|
Moist heat therapy to hamstring muscle on affected (tight) side for 15 minutes will be given to subject. |
| Intervention |
Muscle energy technique
|
Procedure: Subject will be in supine position and the non-treated leg will be either flexed or straight on the table. The treated leg will be flexed at both the hip and knee, and then will be straightened by the therapist until the restriction barrier is identified. Isometric contraction against resistance is introduced at this barrier. Following the 7-10 seconds of contraction, leg will be straightened at the knee towards its new barrier. This slight stretch will be held for up to 30 seconds. 3 sets of this technique will be given.
|
| Intervention |
Neurodynamic sliding
|
Procedure: Subjects will be in supine with their neck and thoracic spine supported in a forward flexed position. Concurrent hip and knee flexion will be alternated dynamically with concurrent hip and knee extension. This combination of movements will be performed for 180 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 – 30 years.
2. Athletes (cricketers, football players, athletics etc)
3. Unilateral hamstring tightness measured by Straight leg raise test : 80 degree or less |
|
| ExclusionCriteria |
| Details |
1. If not willing to participate.
2. Hamstring injury within the past year.
3. Low back pain in the last 6 months.
4. Recent major trauma or fracture of the lumbar spine or lower limb in the last 6 months.
5. Leg length discrepancy.
6. If there are signs of serious pathology such as malignancy, infection, inflammatory disorder, disc prolapse, stenosis, spondylolisthesis, spinal or lower limb deformity. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that Muscle Energy Technique and Neurodynamic sliding will have beneficiary effects on hamstring flexibility and balance among athletes.
Hamstrings flexibility will be assessed by performing passive straight leg raise and active knee extension test. Static and dynamic balance will be assessed by stork stand test and modified star excursion balance test respectively. |
At baseline and immediately post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the prevalence of balance among athletes.
2. To find out the co-relation between hamstrings flexibility and balance. |
At baseline. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hamstring tightness is a common problem and can be a significant health burden to the sufferer. The stiffness and imbalance in hamstrings may affect the individual’s physical functioning including balance, co-ordination, proprioception, agility etc considerably and interfere with athletic performance. A wide variety of treatment protocols for improving hamstrings flexibility are available, however, the most effective management remains an area of debate. Muscle energy technique is claimed to be useful for lengthening a shortened muscle, improving range of motion at a joint and increasing balance. Neurodynamic sliding is thought to decrease neural mechanosensitivity and can be a beneficial technique in the management of hamstring flexibility. As there are no studies found in the literature, there is a need to find the comparative effect of MET and NDS on hamstring flexibility and balance. Finding the comparative effect will clinically provide a guiding stone for therapists on the usage of MET and NDS to make evidence based decisions on the proper use of either mode of treatment. Null hypothesis: There will be no significant difference in effectiveness of Muscle Energy Technique and Neurodynamic sliding in improving hamstring flexibility and balance among athletes. Alternate hypothesis: There will be significant difference in effectiveness of Muscle Energy Technique and Neurodynamic sliding in improving hamstring flexibility and balance among athletes.
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