| CTRI Number |
CTRI/2024/05/067420 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Postural balance in elderly individuals |
|
Scientific Title of Study
|
Correlation of postural balance with reaction time in elderly individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Gore |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082621220 |
| Fax |
|
| Email |
nilarch17@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Samruddhi Sonawane |
| Address |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai |
| Type of Sponsor |
Other [Self funded student study ] |
|
|
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 Archana Gore |
Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
402, Physiotherapy School and Centre, Seth G. S. Medical College and KEM Hospital, OC Building, E Borges Road, opposite Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA |
9082621220
nilarch17@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Seth G. S. Medical College and KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric population between 60-80 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Elderly individuals - both males and females between the age group of 60-80 years 2. Individuals who are: 1) willing to participate in the study 2) providing signed informed consent form 3) able to walk with or without walking aids 3. Individuals able to read, write, and understand either Hindi, Marathi, or English
|
|
| ExclusionCriteria |
| Details |
Individuals with:
Severe orthopedic, neurologic, or uncontrolled cardiorespiratory conditions including uncontrolled diabetes and Hypertension in whom independent ambulation not possible with or without aids
Impairment of vision and hearing
Cognitive impairments
Psychiatric disorder
Any systemic disease
Amputation and having a prosthetic limb
Pain greater than or equal to 7/10 on Numerical Rating Scale (NRS)
Diabetic neuropathy
Absent tactile localisation in the index and middle fingers of Upper limbs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CTSIB score |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reaction time |
Once |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/07/2024 |
| 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
Modification(s)
|
Years="0"
Months="8"
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
|
Falls in elderly individuals are serious and significant problems being a leading cause of injury and related morbidity and mortality in this age group. Impaired balance and slowed reaction time are profound contributors to falls in elderly individuals. Therefore, assessing balance and reaction time is crucial for understanding an individual’s ability to maintain equilibrium and respond to challenges in the environment. The aim of the study is to investigate the correlation between postural balance and reaction time in elderly individuals, recognising the significance of these factors in the prevalence of falls in this age group. This is a descriptive observational study. Participants will be screened in the geriatric OPD and Physiotherapy OPD of tertiary care centre. Inclusion and exclusion criteria will be used to select appropriate participants. Informed consent will be obtained from willing participants. The study will require only one visit, approximately 30 minutes in duration, during one of the routine sessions of the participant. Assessments will include the Clinical Test of Sensory Interaction on Balance (CTSIB) and Deary Liewald Reaction Time task. The collected data will be subjected to normality tests to assess the distribution of data. Statistical analysis will be performed by either Pearson’s or Spearman’s correlation test based on the distribution of data using IBM SPSS v26 (statistical package for social sciences) software.
|