| CTRI Number |
CTRI/2024/11/077258 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
CORRELATION STUDY |
| Study Design |
Other |
|
Public Title of Study
|
The connection between thinking ability and balance while moving in older adults. |
|
Scientific Title of Study
|
Association between cognition and dynamic balance among elderly population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HISHAM P |
| Designation |
Master of Physiotherapy College: Yenepoya Physiotherapy College (Deemed to be University) |
| Affiliation |
Yenepoya Physiotherapy College (Deemed to be University) |
| Address |
Yenepoya Physiotherapy College,University
road,Deralakatte,Mangaluru ,575018
Yenepoya Medical Hospital
,Department of Physiotherapy ,Deralakatte,Mangaluru ,575018
Dakshina Kannada
KARNATAKA
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7012133180 |
| Fax |
|
| Email |
hishampalathingal833@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha D |
| Designation |
AdditionalProfessor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Vice principal room, Staff Division, Physiotherapy department,
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA
575018 India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
HISHAM P |
| Designation |
Master of Physiotherapy College: Yenepoya Physiotherapy College (Deemed to be University) |
| Affiliation |
Yenepoya Physiotherapy College (Deemed to be University) |
| Address |
MPT 2nd year classroom, MPT Division, Physiotherapy department,Yenepoya Physiotherapy College. Naringana, Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7012133180 |
| Fax |
|
| Email |
hishampalathingal833@gmail.com |
|
|
Source of Monetary or Material Support
|
| Elderly Population, Rehabilitation Center, Olavinahalli, Kinya, Mangaluru |
| Elderly Population, Yenepoya Medical Hospital, Deralakatte, Mangaliru |
|
|
Primary Sponsor
|
| Name |
Hisham. P |
| Address |
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA
575018 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hisham P |
Olavinahalli |
Old age home,Olavinahalli,ground floor,Dakshina Kannada,KARNATAKA
Dakshina Kannada
KARNATAKA |
7012133180
hishampalathingal833@gmail.com |
| Hisham P |
Yenepoya Medical College hospital (YMCH) |
Yenepoya Department
of Physiotherapy and
occupational therapy
,5th floor, main block
(Geriatric department
block)
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7012133180
hishampalathingal833@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Olavinahalli permission Letter |
Approved |
| Yenepoya Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Elderly Population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are independent (able to walk independently without any assistance).Both males and females are included.
Participants who are able to obey simple commands.Cognition assured by MOCA. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tug up and go examination. MOCA test for
cognition |
Tug up and go examination which takes about 10min
MOCA test for cognition which takes about 10min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Four Square Step Test for the assessment of dynamic balance |
Four Square Step Test for the assessment of dynamic balance which takes about 10min |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
25/11/2024 |
| 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
|
Total of 84 elderly population of age group 60and above are taken for the study, excluding population with any other kind of health problems. The aim of this study to know the association between the cognition amd dynamic balance. |