| CTRI Number |
CTRI/2025/11/096790 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Role of Fine Motor Exercises in Enhancing Cognitive Function Among the Elderly |
|
Scientific Title of Study
|
Effect Of Fine Motor Skill Training On Cognitive Function Among Elderly Populations- A Single Group Pre-Post Experimental 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 |
Shivani KN |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University road, Dertakatte, Mangaluru,
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9846658340 |
| Fax |
|
| Email |
shivanikn2018@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs. Anjana S. |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mrs .Anjana S. |
| Designation |
Assistant proffesor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya University (Deemed to be University) |
|
|
Primary Sponsor
|
| Name |
SHIVANI K N |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018 |
| 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 |
| SHIVANI K N |
Yenepoya (Deemed to be university) |
Yenepoya University, university road, dertakatte, mangaluru, 575018 Dakshina Kannada KARNATAKA |
9846658340
shivanikn2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fine motor exercises |
In this study, planned to provide 10 sets of fine motor exercises with specific repetitions for 4 weeks to improve cognition in older adults |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 60 years and older, PGI-MS score 20-40 (mild cognitive impairment),Normal vision (with or without correction),Willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Neurological or musculoskeletal conditions affecting cognition, upper limb function, or fine motor skills, Diagnosed psychological conditions impacting thinking or movement,History of major upper limb surgeries or injuries, Terminal illness or serious systemic disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PGI-MS
Purdue pegboard |
Pre test before intervention
Post test after 3 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="23" Sample Size from India="23"
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)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2025 |
| 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
|
This study aims to evaluate the effects of fine motor training on cognitive functions in the aging population. As cognitive decline in older adults often impacts memory, attention, and executive function, it is crucial to explore non-pharmacological interventions that can help mitigate these effects. Fine motor training may promise in stimulating cognitive improvement, but its specific effects on healthy aging remain under explored. The study will utilise a single-group pre-post experiment study design to assess cognitive changes before and after a structured fine motor training program. Participants aged 60-90, who meet the inclusion criteria, will be recruited from Yenepoya Medical College Hospital. The intervention will involve 3 weeks of fine motor exercises, with participants assessed at baseline and post-intervention using standardised cognitive tests such as the Postgraduate Institute Memory Scale (PGIMS) to measure improvements in memory, attention, and executive functions. Data will be analyzed to determine whether fine motor training results in significant cognitive improvements. Ethical approval will be obtained, and informed consent will be collected from all participants before they begin the study. The expected outcomes of this study are to provide valuable insights into the potential benefits of fine motor training as an accessible and non-invasive method to enhance cognitive function in older adults. The findings may inform future interventions and contribute to promoting healthy aging through improved cognitive health. |