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CTRI Number  CTRI/2026/02/103024 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 01/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “Effect of Awareness-Based Functional Training on Everyday Activities in People with Alzheimer’s Disease” 
Scientific Title of Study   Effectiveness of Functional Awareness Training on reducing Anosognosia and its impact on Daily Living Skills for Persons with Alzheimer’s Disease 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poovizhi S 
Designation  Post graduate Student MOT (Neurology)  
Affiliation  Sri Ramachandra Institute of Higher education and Research 
Address  Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Chennai
TAMIL NADU
600116
India 
Phone  9025043860  
Fax    
Email  poovizhi278@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Loganathan S  
Designation  Assistant Professor Sri Ramachandra Faculty of Occupational Therapy 
Affiliation  Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) 
Address  Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Chennai
TAMIL NADU
600116
India 
Phone  9841958099  
Fax    
Email  loganathanot@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Loganathan S  
Designation  Assistant Professor Sri Ramachandra Faculty of Occupational Therapy 
Affiliation  Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU) 
Address  Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (SRIHER) No:1 Sri Ramachandra Nagar Porur Chennai Tamil Nadu
Chennai
TAMIL NADU
600116
India 
Phone  9841958099  
Fax    
Email  loganathanot@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Poovizhi S 
Address  No 7 a tholkappiyan street anna nagar chitlappakkam chrompet chennai 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Poovizhi  Sri Ramachandra Institute of Higher Education and Research (SRIHER).   no 1 ramachandra nagar porur chennai Tamilnadu 600116
Chennai
TAMIL NADU 
9025043860

poovizhi278@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G301||Alzheimers disease with late onset,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  functional awareness training   The Functional Awareness Training program includes: Guided performance of selected activities of daily living (ADLs) Structured self-monitoring and verbal self-reflection during task performance Error identification and correction with therapist-guided feedback Feedback-based video reflection to enhance task awareness Perspective-taking strategies to improve insight into performance Training in intellectual, anticipatory, and emergent awareness 
Comparator Agent  Standarad Occupational Therapy Care  Task-oriented ADL training Functional mobility and transfer training Caregiver education lesiure training 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of Alzheimers disease as per standard diagnostic criteria
Individuals aged sixty years and above
Persons with mild stage Alzheimers disease as determined through clinical assessment
Presence of anosognosia or impaired awareness of functional deficits identified through clinical evaluation
Ability to follow simple instructions and participate in task based training
Medically stable individuals with no acute illness at the time of recruitment
Availability of a primary caregiver who is willing to provide information and support participation in the study
Individuals who provide written informed consent either self consent or consent obtained from a legally acceptable representative 
 
ExclusionCriteria 
Details  Presence of potentially confounding medical neurological psychiatric and orthopedic conditions
Any disabilities that are limiting participation in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in level of functional awareness
Outcome Description:
Improvement in functional awareness as measured by the Self-Evaluation of Daily Functioning (SED-11Q) score. 
Baseline and end of 5 weeks of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in activities of daily living (ADL) performance

Outcome Description:
Improvement in independence in daily living activities measured using the Barthel Index. 
Baseline and end of 5 weeks of intervention. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   20/02/2026 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Anosognosia, or impaired awareness of deficits, is commonly observed in individuals with Alzheimer’s disease and can negatively influence participation in daily activities and rehabilitation outcomes. Reduced functional awareness may limit the effectiveness of conventional occupational therapy interventions aimed at improving activities of daily living (ADLs).

This study aims to evaluate the effect of a structured Functional Awareness Training program on anosognosia and daily living skills in persons with mild Alzheimer’s disease. The study is designed as a randomized, parallel-group interventional behavioral study with pre- and post-intervention assessments.

Participants meeting the eligibility criteria will be randomly allocated into an experimental group or a control group. The experimental group will receive Functional Awareness Training in addition to conventional occupational therapy, while the control group will receive conventional occupational therapy alone. The intervention will be delivered over a period of five weeks, with sessions conducted three times per week.

Primary outcome will be change in level of anosognosia assessed using the Self-Evaluation of Daily Functioning (SED-11Q). Secondary outcome will include change in performance of activities of daily living measured using the Barthel Index. Outcomes will be assessed at baseline and at the end of the intervention period.

The findings of this study are expected to contribute to evidence regarding behavioral and rehabilitation-based approaches targeting functional awareness and daily functioning in individuals with Alzheimer’s disease.


 
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