| CTRI Number |
CTRI/2024/01/061241 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Detecting Fear of Fall in the Elderly with the Help of a Sweating Response |
|
Scientific Title of Study
|
Association of Fear of Fall and Galvanic Skin Response (GSR) in Older Adults: A Case-Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani Iyer |
| Designation |
Postgraduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Biofeedback Room,
Center for Rehabilitation, Department of Physiotherapy, Basement Floor,
Ramaiah Memorial Hospital
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramiah Nagar,
MSRIT Post,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
9167691464 |
| Fax |
|
| Email |
jananiiyer0312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ramesh Debur |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Biofeedback Room,
Center for Rehabilitation, Department of Physiotherapy, Basement Floor,
Ramaiah Memorial Hospital
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramiah Nagar,
MSRIT Post,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ramesh Debur |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Biofeedback Room,
Center for Rehabilitation, Department of Physiotherapy, Basement Floor,
Ramaiah Memorial Hospital,
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramiah Nagar,
MSRIT Post,
Banglore
Bangalore
KARNATAKA
560054
India |
| Phone |
9845544848 |
| Fax |
|
| Email |
rameshdebur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biofeedback Room,
Center for Rehabilitation, Department of Physiotherapy, Basement Floor,
Ramaiah Memorial Hospital
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramiah Nagar,
MSRIT Post,
Banglore - 560054,
India |
|
|
Primary Sponsor
|
| Name |
Janani Iyer |
| Address |
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramaiah Nagar,
MSRIT Post,
Banglore - 560054 |
| 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 |
| Mr Ramesh Debur |
M S Ramaiah Hospitals |
Biofeedback Room,
Center for Rehabilitation, Department of Physiotherapy, Basement Floor,
Ramaiah Memorial Hospital,
Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
MS Ramiah Nagar,
MSRIT Post,
Bangalore
KARNATAKA |
9845544848
rameshdebur@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults between the age of 60-75 years with no known autonomic dysfunction. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Community Ambulators without Assistive Aid
2. Individuals who can Visualise Guided Movements
3. Presence of a Stable Baseline GSR at Rest
4. Cognitively Intact [Mini-Mental State Examination Score>24] |
|
| ExclusionCriteria |
| Details |
1. Known Autonomic Dysfunction
2. Refusing to participate in the Study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mini-Mental State Examination Scale (MMSE)
2. Fall Efficacy Scale-International (FES-I)
3. Galvanic Skin Response (GSR) |
1. Screening
2. Baseline
3. Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
13/01/2024 |
| 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
|
Fear of Fall (FOF) defined as a phobic reaction to standing or walking, also encompasses a decrease in balance self-efficacy, frightened anticipation of falling and deleterious avoidance of activity. FOF is highly prevalent in older adults and a predictor of future falls. Current instruments for measuring FOF range from asking a single dichotomous question to administering scales like the Fall Efficacy Scale, Activity Specific Balance Confidence Scale, etc. These self-reported instruments are susceptible to subjective measurement error and bias. Fear is associated with Autonomic Nervous System (ANS) activation. Galvanic Skin Response (GSR) is a type of electrodermal response which detects changes in the electrical conductivity of the skin due to an increase in sweat gland activity, seen in fearful individuals due to increased Sympathetic Nervous System (SNS) activity. The use of an objective outcome measure like GSR may aid in the identification of FOF and in turn, facilitate the potential use of SNS activity as a biomarker of recovery as well as for evaluating the effectiveness of various types of interventions. |