| 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
|
|
|
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
|
|
|
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
|
|
|
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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