| CTRI Number |
CTRI/2024/09/074091 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the impact of sand vs level ground training on bakance in older adults |
|
Scientific Title of Study
|
Effect of training on sand vs level ground on balance in 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 |
Zahra Punathil |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Deemed to be University |
| Address |
Yenepoya Physiotherapy College, University road, Derlakatte, Mangalore - 575018.
Karnataka
Yenepoya Medical Hospital, Department of Physiotherapy, Derlakatte, Manglore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8921442674 |
| Fax |
|
| Email |
zpunathil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha D |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya 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
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Smitha D |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya 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
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
smithad@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya physiotherapy college, Naringana (Mangalore) Dakshina kannada Karnataka) Pincode 575018 India |
|
|
Primary Sponsor
|
| Name |
Zahra Punathil |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte,Mangaluru, 575018 |
| 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 Smitha D |
Yenepoya medical hospital |
Yenepoya Department of Physiotherapy and occupational therapy ,7th floor, main block (emergency department block)
Dakshina Kannada
KARNATAKA |
9886318394
smithad@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
level ground training |
forward, backward and sidewise training on level ground for 10 meter. Dyration 2 days in 4 week |
| Intervention |
sand training |
forward, backward and sidewise walking on sand for 10 metres. Duration: 2 days in 4 week |
|
Inclusion Criteria
Modification(s)
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age 60 or above
Both gender included
Individuals with montreal cognitive assessment 26 or more
Independent ambulatory without assistance |
|
| ExclusionCriteria |
| Details |
Neurological and musculoskeletal conditions restricting ambulation
Dermatological conditions
Cardiac condition
Non cooperative patient
International fall efficacy score more than 40 score |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
sharpened romberg test
timed up ang go test |
1 week
2 week
3week
4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Recruitment has been completed |