| CTRI Number |
CTRI/2024/06/069067 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying relationship between how well older people can remember things and their ability to move both their lower extremities smoothly. |
|
Scientific Title of Study
|
Correlation of working memory with lower limb motor coordination in elderly. |
| 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 Saraswati Iyer |
| Designation |
Professor and HOD |
| Affiliation |
P.T School and centre, Seth GSMC and KEM Hospital |
| Address |
P.T School and centre, Seth GS Medical College and KEM Hospital, physiotherapy department OC Bldg,
Acharya Dhonde Marg, Parel(E), Mumbai-12
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
9sarasiyer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saraswati Iyer |
| Designation |
Professor and HOD |
| Affiliation |
P.T School and centre, Seth GSMC and KEM Hospital |
| Address |
P.T School and centre, Seth GS Medical College and KEM Hospital, 402 physiotherapy department OC bldg,
Acharya Dhonde Marg, Parel(E), Mumbai-12
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
9sarasiyer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Thakkar |
| Designation |
Master of Physiotherapy |
| Affiliation |
P.T School and centre, Seth GSMC and KEM Hospital |
| Address |
P.T School and centre, Seth GS Medical College and KEM Hospital, 402 physiotherapy department OC bldg
Acharya Dhonde Marg, Parel(E), Mumbai-12
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
thakkarkhushi2405@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Saraswati Iyer |
| Address |
P.T School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 |
| 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 Saraswati Iyer |
P.T School & Centre ,Seth GS Medical College and KEM Hospital. |
402 physiotherapy department OC bldg,KEM Hospital,Acharya Dhonde Marg,Parel(E),Mumbai-12,Mumbai
MAHARASHTRA.
Mumbai
MAHARASHTRA |
02224143435
9sarasiyer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
60-80 years of normal elderly people |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 60-80 years
Both males and females
Community dwelling
Comprehends English, Hindi or Marathi
Montreal Cognitive Assessment (MoCA) score more than 25
Geriatric depression scale (GDS) score less than 9 |
|
| ExclusionCriteria |
| Details |
Any neurological, musculoskeletal or
cardiovascular conditions
Uncontrolled diabetes mellitus and hypertension
Uncorrected visual impairments
Use of any psychotropic drugs
• Visual Analogue Scale (VAS) score more
than 3 (for bilateral lower limb) on activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Digit span test score-working memory |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| lower extremity motor coordination test |
once |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
26/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/08/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Coordination is the execution of precise movement to perform a desired action. The cerebellum is the primary centre in the brain for coordination. Working memory is the small amount of information that can be held in mind and used in the execution of cognitive tasks and is controlled by fronto-parietal cortex. Functional imaging studies demonstrate cerebellar involvement indicating a cognitive role of the cerebellum. Cerebellum has connections with regions involved in cognitive functions-has anatomical connections with prefrontal and parietal association cortex. Functional neuroimaging analysis implicate that performance of cerebellum declines with age. Therefore disruption in cognitive processes can result in errors in motor planning and execution, impacting lower limb coordination. Well-functioning working memory is essential for the efficient coordination of motor activities, and any impairment in working memory can disrupt this coordination. A better understanding of the correlation between cognitive and motor function in elderly could help accurately detect the motor risk factors associated with cognitive decline in early stage. Studying correlation between working memory and lower extremity coordination which will help us to develop rehabilitation strategies and improve quality of life in elderly. To assess working memory digit span test will be used and for lower limb coordination, lower limb motor coordination test will be used. In this study we aim to find the correlation of working memory and lower limb motor coordination in elderly. 51 subjects in the population group of 60-80 years, who fulfil the inclusion criteria will be included in this study. These participants will be assessed for lower limb motor coordination and working memory. The data collected will be analysed according to the distribution of data using Pearson’s Correlation test or Spearman’s Correlation test. |