| CTRI Number |
CTRI/2019/04/018638 [Registered on: 16/04/2019] Trial Registered Prospectively |
| Last Modified On: |
17/11/2019 |
| 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 two physiotherapy methods to reduce tightness of ankle muscles. |
|
Scientific Title of Study
|
The Immediate Effect Of Static Stretching And Cupping Therapy on Weight Bearing Lunge Test And Star Excursion Balance Test In Asymptomatic Young Adults With Gastro-Soleus Tightness : A Comparative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANTOSH METGUD |
| Designation |
HOD and Associate Professor ( Department of Orthopaedic Manual Therapy ) |
| Affiliation |
KLE Academy of Higher Education And Research Institute of Physiotherapy. |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy.
Nehru Nagar
Belagavi,Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
metgud_santosh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
RITU RAVI CHHABRA |
| Designation |
MPT STUDENT (ORTHOPAEDIC MANUAL THERAPY) |
| Affiliation |
KLE Academy of Higher Education And Research Institute of Physiotherapy. |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy.
Nehru Nagar
Belagavi,Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9930038570 |
| Fax |
|
| Email |
rrchhabra96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RITU RAVI CHHABRA |
| Designation |
MPT STUDENT (ORTHOPAEDIC MANUAL THERAPY) |
| Affiliation |
KLE Academy of Higher Education And Research Institute of Physiotherapy. |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy.
Nehru Nagar
Belagavi,Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9930038570 |
| Fax |
|
| Email |
rrchhabra96@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH INSTITUTE OF PHYSIOTHERAPY,
NEHRU NAGAR,
BELAGAVAI,
KARNATAKA,
590010 |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
KLE Academy And Higher Education And Research Institute of Physiotherapy.Nehru Nagar.590010.Karnaatka. INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| SANTOSH METDGUD |
KLE Academy of Higher Education And Research |
KLE Academy of Higher Education and Research Institute of Physiotherapy, Nehru Nagar, Belgavi,KARNATAKA .590010
Belgaum
KARNATAKA |
9880088400
metgud_santosh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional Research And Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gastro-Soleus Tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRY CUPPING |
Patient is in Prone position with foot outside the plinth.
Coconut oil will be applied to the Gastro-Soleus prior to the application of
cups.3 plastic valve cups will be placed in vertical line.Using a handheld suction
pump,each cup will be pumped so that skin will be filled up to half of the cup.The cups
will remain in place for 3 minutes .After 3 minutes were up, all but one cup will be
removed.For the remaining minute the Therapist will glide the cup up and down the
Gastro-Soleus with the suction still intact.
Total treatment time :
7 minutes. |
| Comparator Agent |
STATIC STRETCHING |
Position Of the patient is in Stride standing with
Control leg forward and knee flexed.
Test leg is placed behind with knee straight and heel on the ground.
Procedure: Lean forward towards the wall until a stretch sensation is felt at the gastro-soleus (calf ) region .
4 repetition with 30 sec hold with 10 sec rest in between.
Total time : 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and females aged between 19-28 years.
2. Asymptomatic individuals with bilateral Gastro-soleus muscle tightness assessed
according to Silfverskiold test.
3. Those without lower limb muscle pain, restriction in range of motion.
4. Participants willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Injury to the leg in the past year
2. Had an intervention for calf muscle flexibility
in the past three months
3. Blood flow dysfunction
4. Hemorrhagic disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Bearing Lunge Test |
Pre Intervention And Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anterior Direction Star Excursion Balance Test |
Pre Intervention and Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2019 |
| Date of Study Completion (India) |
20/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gastro-soleus tightness and limited ankle dorsiflexion range of motion are related to a number of lower limb disorders like tibial pain,IT band syndrome, Plantarfascitis , knee pain etc. Studies show that static stretching is one of the most widely used intervention to improves the enchancibility and extensibility of Gastro-soleus tightness causing increase in dorsiflexion range of the ankle.
Cupping is an ancient chinese medicine, an alternative medicine to accupunture. There are various types, one being dry cupping. Cupping therapy is used in various diseases,pain, to improve flexibility by releasing the adhesions caused by the soft tissue thereby increasing the range of motion.Studies have been done on cupping therapy effect on hamstring flexibility, IT band syndrome, low back pain, neck pain. etc
Even though cupping therapy on gastro-soleus is done in clinical practise, its research progress is relatively less.
Also to overcome the disorders caused due to gastro-soleus tightness and to enhance flexibility in everyday life ,there is a need to find interventions combacting these restrictions.
and to compare the widely used dry cupping with other conventional techniques like static stretching , there is a need to initiate the study.
Weight bearing lunge test and star excursion balance test have a significant relation with dorsiflexion range of motion and on dynamic balance.
Hence the purpose of the study is to comapre the immediate effect of static stretching and cupping therapy on weight bearing lunge test and star excursion balance test in asymptomatic young adults with gastro-soleus tightness. |