| CTRI Number |
CTRI/2024/10/075416 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A New Device for Reducing Calf Pain and Tightness Through Stretching and Vibration Therapy |
|
Scientific Title of Study
|
Designing, Developing and Testing of an innovative device for calf muscle flexibility and relaxation- A Multiphasic Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Delvadiya Priya Dayabhai |
| Designation |
Post Graduated student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207,School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
9426482969 |
| Fax |
|
| Email |
pdelvadiya022@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Doshi |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207,School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
7405346112 |
| Fax |
|
| Email |
komal.doshi@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Delvadiya Priya Dayabhai |
| Designation |
Post Graduated student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207,School of Physiotherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
9426482969 |
| Fax |
|
| Email |
pdelvadiya022@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Delvadiya Priya Dayabhai, School of Physiotherapy, RK University, kasturbadham, Rajkot-Bhavnagar highway, Rajkot-360020, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy |
| Address |
School of Physiotherapy, RK University, kasturbadham, Rajkot-Bhavnagar highway, Rajkot-360020, Gujarat, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Delvadiya Priya Dayabhai |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy Department Room no.1, opp Meghani rang bhuvan, Bhaktinagar Circle, Rajkot, Gujarat, India
Rajkot
GUJARAT |
9426482969
pdelvadiya022@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified, (3) ICD-10 Condition: M629||Disorder of muscle, unspecified, (4) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Revive CalfX Device |
This Device For Calf Muscle ,Device will be given for 1 week. Intervention given in this device is first 30-180seconds local vibration at posterior compartment of leg in muscle direction and then calf muscle stretching exercise in supine position 30s hold, 3 repetitions and also used for individual intervention also. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Calf Pain with Calf Muscle Tightness
2) Silfverskiold Test Positive |
|
| ExclusionCriteria |
| Details |
1) Lower Limb Fractures
2) Tendon ruptures of Lower Limb
3) Osteoarthritis of Knee
4) Nerve injury of Lower Limb
5) Previous surgeries of Lower Limb
6) Not willing to sign informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Numeric Pain Rating Scale
2) Ankle Dorsiflexion Range of Motion
3) QUEST 2.0 Scale |
Pre outcome at baseline (first day of training)
Post outcome after 1 week(last day of training) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/12/2024 |
| 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="3"
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
|
Title : Designing, Developing and Testing of an Innovative Device For Calf Muscle Flexibility and Relaxation : A Multiphasic Exploratory Device
Investigators : Delvadiya Priya Dayabhai; PT, Dr. Komal Doshi; MPT, School of Physiotherapy, RK University.
Background : The calf muscle namely, gastrocnemius and soleus muscles plays a crucial role in facilitating planter flexion of the foot, essential for various locomotor activities. Insufficient calf muscle flexibility can result in reduce performance, increase risk injury and persistent pain and it commonly affects people with sedentary lifestyle, overuse of calf muscle activities and individuals with condition like planter fascitis and achiilies tendinitis. Conservative treatment for flexibility and relaxation such manual stretching, foam roller, massage gun etc. This clinical trail aim to assess the feasibility and effectiveness of innovative device which is designed for calf flexibility and relaxation by stretching combining with vibration in to one device, cost effective.
Method : Following ethical approval, 60 subjects will be selected as per inclusion criteria and will receive innovative device. Outcome will be assess before treatment ( baseline) and post treatment after 1 week with Numeric Pain Rating Scale and ankle range of motion.
The study is divided into 3 phases:
Phase 1: Designing of an innovative device for calf muscle flexibility and relaxation.
Phase 2: Developing of an innovative device for calf muscle flexibility and relaxation.
Phase 3: Determine feasibility and effectiveness of an innovative device for calf muscle flexibility and relaxation.
|