| CTRI Number |
CTRI/2023/06/054002 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Inter Rater Reliability and concurrent validity of Stroke Specific Shoulder Disability Index. |
|
Scientific Title of Study
|
Inter Rater Reliability and concurrent validity of Stroke Specific Shoulder Disability Index - A Cross Sectional 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 |
Jatin Sangwan |
| Designation |
MPT Student |
| Affiliation |
MPT Student, MMIPR, MMDU, Mullana, Ambala |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana,India
Ambala
HARYANA
133207
India |
| Phone |
8708502582 |
| Fax |
|
| Email |
sangwanjatin1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Chatterjee |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana,India
Ambala
HARYANA
133207
India |
| Phone |
8708502582 |
| Fax |
|
| Email |
subhasishphysio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Chatterjee |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana,India
Ambala
HARYANA
133207
India |
| Phone |
8708502582 |
| Fax |
|
| Email |
subhasishphysio@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 |
|
|
Primary Sponsor
|
| Name |
Jatin Sangwan |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana,India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jatin Sangwan |
Maharishi Markandeshwar superspeciality Hospital |
Neurological OPD, Maharishi Markandeshwar Deemed to be university
Ambala
HARYANA |
8708502582
sangwanjatin1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMIMSR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individual with stroke
MMSE more than 24 |
|
| ExclusionCriteria |
| Details |
Transient ischaemic attack
Suffering from another neurological disorders
Patient with multiple stroke
History of the trauma to the affected extremity
Systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroke specific shoulder disability index |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fugl meyer assessment of upper extremity |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
29/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Inter rater reliability and concurrent validity of stroke specific shoulder disability index was calculated in this study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are many scales developed for assessment of upper extremity functions in stroke patients. But they could not include the shoulder domains like shoulder pain, subluxation, ROM and quality of life. A validated scale i.e. stroke specific shoulder disability index was developed which covers all domains. There is no specific study until date which calculate the inter rater reliability and concurrent validity of stroke specific shoulder disability index. So it is necessary to conduct a study which shows inter rater reliability and concurrent validity of this scale. |