| CTRI Number |
CTRI/2025/07/091767 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring How The Feeling On The Soles Of Your Feet Influences Balance When Depending On Vision |
|
Scientific Title of Study
|
Relationship Of Plantar Cutaneous Sensation On Visual Reliance Useing Dynamic Balance Test |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hema Biju |
| Designation |
Post Graduate |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8296341589 |
| Fax |
|
| Email |
hemabiju99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amratha G Shetty |
| Designation |
Asso Prof |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8296341589 |
| Fax |
|
| Email |
amrathagshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hema Biju |
| Designation |
Post Graduate |
| Affiliation |
Alvas college of physiotherapy |
| Address |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8296341589 |
| Fax |
|
| Email |
hemabiju99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Monofilament |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| HEMA BIJU |
Alvas College of Physiotherapy |
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA |
8296341589
hemabiju99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reduced Plantar Cutaneous Sensation in Elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Consent to participate in study
Participant who is able complete 8ft tandem walking test within 20sec
Subject who is able to recognize fingers in finger counting test from 20ft away
|
|
| ExclusionCriteria |
| Details |
Individuals with visual and auditory impairment
Individuals who have moderate to severe impairment in balance
Individuals who have severe neurological or cardiovascular or musculoskeletal conditions
Patients who have difficulty in ambulation
Patients who had lower limb surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plantar cutaneous sensation :
Monofilament
Visual reliance: Walking on beam test
|
After recruitment
T0-Monofilament
T1-Walking on beam test
T0-5min T1-15min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI: weight (in kg )/height ( in meter square )
Presence of foot arch : Arch index.
Lower limb muscle strength: 5 times sit to stand.
Flexibility of lower limb : Chair sit & reach test.
Physical activity: Physical activity scale for elderly. |
After recruitment
T0-Bmi
T1-Foot Arch
T2-Flexibility Lower Limb
T3-Lower Limb Muscle Strength
T4-Physical Activity
T0-2min,T1-2 min,T2-5min,T3-5min, T4-5min. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/11/2025 |
| 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="8"
Days="0" |
|
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
|
|
The aim
of the study is to find out how the change in plantar cutaneous sensation
affect the dynamic balance under varying visual condition and this study will also give information about how the the plantar cutaneous sensation affect the age gender flexibility BMI physical activity foot arch lower limb muscle strength . It is done by using the monofilament for the plantar cutaneous sensation and walking on beam test performance under varying visual circumstances for visual reliance 5 times sit to stand for lower limb muscle strength pase scale for physical activity foot arch index for foot arch sit and reach test for flexibility i
|
|