| CTRI Number |
CTRI/2025/08/092622 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hindi version of Trunk Impairment sacle 2.0 |
|
Scientific Title of Study
|
Hindi Translation, Content Validation and Reliability Testing of Trunk Impairment Scale 2.0 (TIS 2.0) in Patients with Post Stroke Hemiplegia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhashish Chatterjee |
| Designation |
Supervisor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground floor, room no 1, MMDU, Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhashishphysio@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhashish Chatterjee |
| Designation |
Supervisor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground floor, room no 1, MMDU, Mullana, Haryana
HARYANA
133207
India |
| Phone |
8708660994 |
| Fax |
|
| Email |
subhashishphysio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Ruchika |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD,Ground floor, room no 1, MMDU, Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07710454046 |
| Fax |
|
| Email |
ruchikagandotra123@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMIPR , neuro OPD , ground floor , Room no. 1 , MMDU , Mullana , Haryana 133207 |
|
|
Primary Sponsor
|
| Name |
Ruchika |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD,Ground floor, room no 1, MMDU, Mullana, Haryana ,133207 , 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 |
| Dr Subhasish Chatterjee |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Neuro Physiotherapy OPD,Room No. 01,Maharishi Markandeshwar Deemed To be University,Mullana,Ambala,Haryana
Ambala
HARYANA |
8708660994
subhashishphysio@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee of Maharishi Markandeshwar Institute of Medical Sciences and Research,Maharishi Markandeshwar (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Stroke patients with sub-acute more than 7 days and less than or equal to 3 months and chronic more than 3 months suffering from ischemic or hemorrhagic stroke were recruited.
2. Individuals with basic understanding of Hindi.
3. Able to sit independently for 10 seconds.
4. Both males and females are included.
|
|
| ExclusionCriteria |
| Details |
1.Musculoskeletal disorders.
2.Non-native Hindi speakers.
3.Patients with poor general health including neurological conditions
4.Segmentary absence of a limb
5.Uncontrolled comorbidities dementia, any mental deficit, which may affect cognitive performance.
6.Functional limitation as a result of moderate to severe pain, and inability to follow the verbal instructions by the assessor. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale 2.0 |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale 2.0 |
Baseline |
|
|
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)
|
01/09/2025 |
| 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="1"
Months="0"
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
|
The Trunk Impairment Scale 2.0 (TIS 2.0), developed by Verheyden and Kersten in 2010, assesses trunk impairments in stroke patients using two subscales: Dynamic Sitting Balance and Coordination. It improved upon the original 2004 version by removing the static balance item due to ceiling effects and poor validity. While TIS 2.0 has been translated into several languages, no Hindi version exists, limiting accessibility for Hindi-speaking populations. A validated Hindi version is essential to ensure accurate understanding and reliable patient feedback, thereby enhancing clinical assessment and patient well-being. |