| 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
|
|
|
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. |