| CTRI Number |
CTRI/2025/07/090334 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to find out effect if a special exercise program can help older adults with walking and thinking abilities. |
|
Scientific Title of Study
|
Effect of Multimodal Cawthorne-Cooksey Exercises on Enhancing Locomotion and Cognitive Functions in Older Adults with
Mild Cognitive Impairment: A Single-Blind Experimental Design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNIGDHA NAYAK |
| Designation |
MPT STUDENT |
| Affiliation |
Abhinav Bindra Sports Medicine and Research Institute |
| Address |
ABSMARI NH-16, Plot No. 273, Pahala, Bhubaneswar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
7008245153 |
| Fax |
|
| Email |
snig2509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Mishra |
| Designation |
ASSOCIATE PROFESSOR, ABSMARI |
| Affiliation |
Abhinav Bindra Sports Medicine and Research Institute |
| Address |
ABSMARI NH-16, Plot No. 273, Pahala, Bhubaneswar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9438150665 |
| Fax |
|
| Email |
priyadarshinimishra@absmari.com |
|
Details of Contact Person
Public Query
|
| Name |
Snigdha Nayak |
| Designation |
MPT STUDENT |
| Affiliation |
Abhinav Bindra Sports Medicine and Research Institute |
| Address |
ABSMARI, NH-16, Plot No. 273, Pahala, Bhubaneswar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
7008245153 |
| Fax |
|
| Email |
snig2509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self- funded by Principal Investigator
Snigdha Nayak
Address- Bamphi Sahi, Post office- Telenga Bazar, Police station- Purighat, Cuttack, Odisha, India, Pin code- 753009 |
|
|
Primary Sponsor
|
| Name |
Snigdha Nayak |
| Address |
Abhinav Bindra Sports Medicine and Research Institute, NH-16, Plot No. 273, Pahala, Bhubaneswar, Odisha 752101 |
| 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 Snigdha Nayak PT |
Community-based setting- Urban Ward 30, Cuttack |
Bamphi Sahi, Post office- Telenga Bazar, Police Station- Purighat, Cuttack, Pin code- 753009
Cuttack
ORISSA |
7008245153
snig2509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABSMARI Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild Cognitive Impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise Program
|
The control group will receive a conventional exercise program, for 50 minutes per session, 2 days a week, for a total duration of 8 weeks.
|
| Intervention |
Multimodal Cawthorne-Cooksey Exercises |
The experimental group will receive an exercise intervention for 50 minutes per session, 2 days a week, for a total duration of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Screening for Mild Cognitive Impairment (MCI) using SLUMS (Saint Louis University Mental Status Examination)
Cut off score 21 to 26 for individuals with high school education and 20 to 24 for individuals with less than high school education
Timed Up and Go with Cognitive task score greater than 15 seconds for balance impairment
Ability to read and understand basic English instructions |
|
| ExclusionCriteria |
| Details |
Any history of psychiatric, neuromuscular, orthopaedic, neurological, and rheumatologic disorder.
Illiteracy or inability to follow study instructions.
Participants unwillingness to continue the study.
Incidence of diseases such as stroke during the study.
Discontinuation or dropout from intervention for any reason. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Gait Assessment (FGA) |
Baseline (Week 0) and post-intervention (Week 8) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TMT PART-A & B; STROOP TEST |
Baseline (Week 0) and post-intervention (Week 8) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2025 |
| 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="3"
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 effect of Multimodal Cawthorne-Cooksey Exercises on cognitive function and gait performance in older adults with mild cognitive impairment. Participants aged 60 to 80 years with mild cognitive impairment and slow gait under cognitive load will be included. The intervention will be delivered over a period of eight weeks. Outcome measures will be assessed before and after the intervention to observe changes in cognitive function and gait. The study seeks to determine the effectiveness of this structured physiotherapy program in improving cognition and gait performance in this population. |