| CTRI Number |
CTRI/2024/08/072227 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Improving Balance and Quality of Life in Seniors: The Power of Proprioceptive Training" |
|
Scientific Title of Study
|
Effects of proprioceptive training on balance and quality of life in older adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chorghe Juilee Sunil |
| Designation |
PG student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
University road, Derlakatte, Ullal, Karnataka
Physiotherapy OPD, 7 floor
University road, Derlakatte, Ullal, Karnataka
Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09284417078 |
| Fax |
|
| Email |
chorghejuilee22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha D |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
University road, Derlakatte, Ullal, Karnataka
Physiotherapy OPD, 7 floor
University road, Derlakatte, Ullal, Karnataka
Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
drsmitha82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chorghe Juilee Sunil |
| Designation |
PG student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
University road, Derlakatte, Ullal, Karnataka 575018
Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9284417078 |
| Fax |
|
| Email |
chorghejuilee22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College,Naringana (Mangalore)
Dakshina kannada (Karnataka)
pincode: 575018
India. |
|
|
Primary Sponsor
|
| Name |
Chorghe Juilee Sunil |
| Address |
University road, Derlakatte, Ullal, Karnataka 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Chorghe Juilee Sunil |
Yenepoya Medical College Hospital |
Physiotherapy OPD, 7 floor
Dakshina Kannada
KARNATAKA |
9284417078
chorghejuilee22@gmail.com |
|
|
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 |
| Intervention |
Direct Proprioceptive training |
as one leg balance test, one leg 3 way kick, banded Tri planar toe taps and tree pose.
Duration: 6 weeks |
| Comparator Agent |
indirect proprioceptive training |
passive stretching, active exercise (straight leg raise), active heel slides.
Duration: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Older adults aged 60 years or above
Experienced fall in past years
Participating voluntarily in the study
Walking independently without assistance
|
|
| ExclusionCriteria |
| Details |
Patient with cognitive decline (Score 24 in the Mini Mental Scale) or those unable to understand or take part in the measurement process
Patient unable to tolerate moderate physical activity owing to cardiovascular or respiratory illness
Patient with disorders affecting balance different from those caused by aging such as dizziness or vestibular disorders that require medications with a potential effect on balance
High risk of falls (51 on the Morse Fall Scale [MSF])
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time up and go test
World health organization quality of life - BREF(WHOQOL-BREF) |
2 weeks
4 weeks
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
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 Yet Recruiting |
| 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
|
The study titled "Effects Of Proprioceptive Training on Balance and Quality of life in older adults" will be performed in elderly participants from Geriatric and medicine wards. The participants will be divided into two groups and pre assessment will be taken(TUG and WHOQOL-BREF questionnaire) and treatment will be provided accordingly. The control group will undergo indirect proprioceptive training and experimental group will undergo direct proprioceptive training and after 2 weeks, 4 weeks and 6 weeks post assessment will be taken(TUG and WHOQOL-BREF questionnaire) |