FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095167 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Hindi Adaptation and Validation of ASES Shoulder Assessment Form in Frozen Shoulder Patients 
Scientific Title of Study   Hindi Translation, Cross-Cultural Adaptation, Validity and Test-Retest Reliability of American Shoulder and Elbow Surgeons Shoulder Assessment Form in individuals with Frozen Shoulder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Sharma  
Designation  PG Student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8988814484  
Fax    
Email  shweta05006@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ADITI POPLI 
Designation  Assistant Professor  
Affiliation  Maharishi Markandeshwar Deemed to be University  
Address  Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9896461613  
Fax    
Email  aditi.popli@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  ADITI POPLI 
Designation  Assistant Professor  
Affiliation  Maharishi Markandeshwar Deemed to be University  
Address  Maharishi Markandeshwar Deemed to be University, Mullana

Ambala
HARYANA
133207
India 
Phone  9896461613  
Fax    
Email  aditi.popli@mmumullana.org  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India (133207) 
 
Primary Sponsor  
Name  Shweta Sharma 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India, 133207 
Type of Sponsor  Other [(SELF)] 
 
Details of Secondary Sponsor  
Name  Address 
Aditi Popli  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India, 133207 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shweta Sharma  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Room No. S-116, super specialty OPD MM Super specialty Hospital, Mullana
Ambala
HARYANA 
8988814484

shweta05006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee, Maharishi Markandeshwar Intitute of medical Science and Research, Mullana- Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Both male and female
2.Age group : 40-60 years
3.Frozen shoulder
4.Sufficient cognitive ability to comprehend the questionnaire
5.Patient with good knowledge of Hindi
 
 
ExclusionCriteria 
Details  1.Patients have other shoulder pathologies
2.Patients having cognitive behavior problems
3.Patient with fluent English
4.Un-cooperative patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
American Shoulder and Elbow Surgeons Shoulder Assessment Form  Baseline and after 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   03/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
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  

 American Shoulder and Elbow surgeons Shoulder Assessment Form (ASES) is the outcome measure used by the patients to evaluate the function and pain status of the shoulder. This scale was developed in 1994 by the research committee of American Shoulder and Elbow Surgeons (ASES). It is useful in determining the functional and pain status of patients with shoulder conditions like frozen shoulder conditions which usually affect patients’ day-to-day life activities. The purpose of this study is to translate American Shoulder and Elbow surgeons Shoulder Assessment Form (ASES) into the Hindi version and to evaluate its validity and test-retest reliability. A cross-sectional study. The study method includes the translation of the ASES in Hindi language from English by 2 translators i.e.T1 and T2 from medical and non-medical background respectively. The recording observer then takes a seat to create a T12 version of the translated scale. The reverse translation from the T12 form to the previous form is now being done. Then, an expert panel analyses all the stages and all of the scale items that the translated form of the scale is free of errors, allowing it to be field tested. Evaluation of content’s validity is done. The Pre-final form is then fully tested on patients, and the scale’s validity is reported. Finally, the translated scale version will be analyzed by the ethics committee.

 
Close