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CTRI Number  CTRI/2025/08/092942 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
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   EFFECT OF ACTIVITY BASED EXERCISES TO IMPROVE HAND STRENGTH AND HAND FUCTION IN PATIENTS WITH ELBOW PAIN 
Scientific Title of Study   EFFECT OF TASK ORIENTED EXERCISES ON HAND GRIP STRENGTH AND DEXTERITY IN PATIENTS WITH LATERAL EPICONDYLITIS- A RANDOMISED CONTROL 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  SAKSHI DILIP CHATURE 
Designation  MUSCULOSKELETAL PHYSIOTHERAPY RESIDENT 
Affiliation  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMEDNAGAR PIN 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8888162755  
Fax    
Email  sakshichature@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SUKHPREET PABLA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMEDNAGAR PIN 413736
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMEDNAGAR PIN 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9638299273  
Fax    
Email  pablasukhpreet@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SUKHPREET PABLA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMEDNAGAR PIN 413736
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI BK TALUKA RAHATA DISTRICT AHMEDNAGAR PIN 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9638299273  
Fax    
Email  pablasukhpreet@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES 
Address  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL RAHATA DIST AHMEDNAGAR LONI BK PIN 413736  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SAKSHI DILIP CHATURE  DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY  OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY FOURTH FLOOR DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY AHMADNAGAR MAHARASHTRA
Ahmadnagar
MAHARASHTRA 		 8888162755

sakshichature@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. APJ AK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M771||Lateral epicondylitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional group  3 Days/Week 10 repetitions× 2 Sets • Active range of motion for Elbow • Active range of motion for Wrist 3 Days/Week 10 repetitions× 2 Sets with 10 sec Hold • Stretching for Wrist Flexors 3 Days/Week 10 repetitions× 2 Sets with 10 sec Hold • Stretching for Wrist Extensors 3 Days/Week 10 repetitions×2 Sets • Strengthening for Wrist Flexion • Strengthening for Wrist Extension  
Intervention  Task Oriented exercises  1 Phase 1 (Week 0-2) 3Days/Week • Wrist Extension Isometrics • Active Elbow and Wrist Flexion and Extension • Active Supination and Pronation • Opening A Cap of Bottle • Stacking A Block Over Another • Scrunching Of Paper • Folding A Paper into Different Shapes Phase 2 (Week 2-3)• Wrist Extension Dumbbell Curl • Elbow Flexion and Extension Using Dumbbell • Resisted Exercises for Wrist Flexion and Extension Using Thera band(red) • Gently Throwing and Catching a Foam Ball Phase 3 (Week 3-4) 3Days/Week 10 Repetitions×2 Sets • Resisted Exercises for Wrist Flexion and Extension Using Thera Band (Green) • Forearm Rotation Strengthening 10 Repetitions×2 Sets • Writing A Paragraph • Tying A Shoe Lace • Cutting A Paper with Scissors • Pop Bubble Wrap with Thumb and Index Finger • Screw And Unscrew Nut Bolts  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Both males and females
Adult aged 30 to 50 years
Patients diagnosed with lateral epicondylitis.
Mills Test positive
VAS score more than or equal to 4
 
 
ExclusionCriteria 
Details  Patients with other orthopedic conditions of upper extremity
Patients with Neurological conditions
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Sphygmomanometer
2.Jebson Taylor hand function scale 		 All outcomes are measured at baseline and after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   23/08/2025 
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="2"
Months="0"
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  

EFFECT OF TASK ORIENTED EXERCISES ON HAND GRIP STRENGTH AND DEXTERITY IN PATIENTS WITH LATERAL EPICONDYLITIS- A RANDOMISED CONTROL TRIAL

Dr. Sakshi Chature1 Musculoskeletal Physiotherapy Resident Dr APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India Email sakshichature@gmail.com

Dr. Sukhpreet Pabla2 Associate Professor, Department of Orthopaedic Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India Email pablasukhpreet27@gmail.com

AIM – To find efficacy of Task oriented Exercises on Hand grip strength and dexterity in Patients with Lateral Epicondylitis.

OBJECTIVES OF THE STUDY

To find the effect of Task-oriented exercises on Hand grip Strength by Sphygmomanometer and Dexterity by Jebson Taylor hand function test in Patients with Lateral Epicondylitis

SELECTION CRITERIA

INCLUSION CRITERIA

·   Both males and females

·   Adult aged 30 to 50 years

·   Patients diagnosed with lateral epicondylitis.

·   Mills Test positive

·   VAS score more than or equal to 4

EXCLUSION CRITERIA

·  Patients with other orthopaedic conditions of upper extremity

·  Patients with Neurological conditions

METHODOLOGY

Source of data: Department of Orthopedics, Dr. APJ Abdul Kalam College of Physiotherapy, PIMS

Study setting: This study will be conducted in the Department of OPD of Orthopedic Physiotherapy, Dr. APJAK College of Physiotherapy.

Type of Study: Experimental study

Intervention Period: Participants will be receiving intervention for 4weeks, for 3days per week  each session of 45mins

Study design: A Randomized control trial

Sample size: 66

Participants: Patients with Lateral epicondylitis

Sampling method: Simple random sampling

Study duration: 2 Year

Materials to be used: Consent form, sphygmomanometer, scale, paper, Stopwatch, pen

 Outcome Measures

1.      Hand grip strength measured with Sphygmomanometer

2.      Dexterity measured by Jebson Taylor hand function scale

PROCEDURE

After receiving ethical clearance by the Institutional Ethical Committee of Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS-DU.  The participants were selected on the basis the inclusion and exclusion criteria mentioned above. The consent of the participants will be taken, the ones willing to participate in the project will be selected. All information, procedure of the study, how it will be beneficial to the participants will be explained. Patient with Lateral epicondylitis aged 30 to 50 will be selected. The participants will be randomly distributed into two exercise groups:

Group A Task Oriented Exercises

Group B Conventional exercises

All groups received training for 45 minutes three times a week for four weeks

STUDY VARIABLES

NAME OF VARIABLE

MEASUREMENT SCALE

MEASUREMENT METHOD

AGE

NOMINAL

VERBALLY

GENDER

NOMINAL

OBSERVATION

HAND GRIP STRENGTH

INTERVAL

SPHYGMOMANOMETER

DEXTERITY

INTERVAL

JEBSON HAND FUNCTION SCALE

 STATISTICAL ANALYSIS

Statistical Analysis will be done using appropriate test.

STUDY PERIOD

2 years from the time of approval of the study.

 AMENDMENT OF PROTOCOL

 No change in the study procedure shall be affected without the mutual agreement of investigator, physician and ethical committee.

CONFIDENTIALITY

The identity of patient generated in the study will be bounded in strict confidence. The remaining data will be available only to the investigator involved in the study and to the regulatory authorities.

 
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