| CTRI Number |
CTRI/2025/04/084498 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Developement and Validation of scale |
| Study Design |
Other |
|
Public Title of Study
|
Developing a scale for assessment of memory loss and learning problems and testing the scale how accurate it will be for older age people |
|
Scientific Title of Study
|
Development of assessment scale for cognitive functions in dementia & testing its validity and reliability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Sharma |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar Haryana India |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 India
Hisar
HARYANA
125001
India |
| Phone |
8890969023 |
| Fax |
|
| Email |
rashmisharma9884@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Sharma |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar Haryana India |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 India
Hisar
HARYANA
125001
India |
| Phone |
8890969023 |
| Fax |
|
| Email |
rashmisharma9884@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jaspreet Kaur |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar Haryana |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 India
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_physio@gjust.org |
|
|
Source of Monetary or Material Support
|
| Rashmi Sharma MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Prof Jaspreet Kaur |
Department of Physiotherapy |
Room number 04 Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana 125001 India
Hisar
HARYANA |
9466092657
jaspreet_physio@gjust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of GJUS &T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F039||Unspecified dementia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Having symptoms of cognitive impairment |
|
| ExclusionCriteria |
| Details |
Below the age of 50
Severely affected neurological condition patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Memory
2. Spatial Awareness
3.Language
4.Attention
5.Behavior
6.ADLs |
Reliability and validity will assess within limit not less than 7 days and not more than 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Behavior
ADLs
Attention |
Reliability and validity will assess within limit not less than 7 days and not more than 14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2025 |
| 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="0"
Months="0"
Days="28" |
|
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
|
Developing a scale for cognitive functions in dementia and testing its validity and reliability in the Hindi & English language. The procedure of scale development will consist major phases items and domain generation , grouping items in domains, content validation by panel of experts then first draft and scoring criteria will finalize and then final draft of scale ,give a appropriate name and editing and modifications will do on the aggrement of level of experts and then final revision of the scale and then translate the scale from the Hindi department of GJUS&T and then testing the validity by pilot testing study design and then also testing its validity by test -retest method by giving the scale to the old age population of dementia on two different occasion at the interval of seven days. |