| CTRI Number |
CTRI/2024/04/065623 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of fully immersive virtual reality and cognitive training on global cognition,quality of life,iadls and brain activities in patients with mild to moderate Alzheimers disease |
|
Scientific Title of Study
|
Efficacy of Immersive Virtual Reality and Cognitive Training on various parameters in patients suffering from Alzheimers Disease:A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reena Kumari |
| Designation |
Research scholar |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar,Haryana |
| Address |
Department of physiotherapy
Guru Jambheshwar University of Science and Technology,Hisar,Haryana
Hisar
HARYANA
125001
India |
| Phone |
8059633556 |
| Fax |
|
| Email |
rs220170090102@gjust.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar,Haryana |
| Address |
Department of physiotherapy
Guru Jambheshwar University of Science and Technology,Hisar,Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology,Hisar,Haryana |
| Address |
Department of physiotherapy
Guru Jambheshwar University of Science and Technology,Hisar,Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Reena Kumari Research scholar,Department of Physiotherapy.GJUS&T,Hisar-125001,Haryana(India) |
|
|
Primary Sponsor
|
| Name |
Reena Kumari |
| Address |
Department of physiotherapy
Guru Jambheshwar University of Science and Technology,Hisar,Haryana |
| 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 |
| Reena Kumari |
Guru Jambheshwar University of Science and Technology,Hisar,Haryana |
Room no.109,Research Lab,Department of physiotherapy,Guru Jambheshwar University of Science and Technology,Hisar-125001
Hisar
HARYANA |
8059633556
kumarireena8221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G300||Alzheimers disease with early onset, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive training |
The intervention will include domain specific tasks for memory training, attention training, and calculation training. The participants will perform tasks thrice a week for Eight weeks. |
| Comparator Agent |
Control group |
Participants in control group will perform cognitive task such as reading newspaper, writing, completing mathematical exercises, puzzles and games. |
| Intervention |
Immersive Virtual Reality
|
Full immersion VR environment will be created for the participants with the help of head mounted device(HMD) which will consists of games involving multidomain cognitive task to assess attention, executive function, ability to perform calculation, visuospatial orientation, verbal and visual memory, working memory etc. Each session will last for 20-30 minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients older than 60 years with diagnosis of AD, consent in participation,absence of vision and hearing impairment likely to effect social life,ability to read and write |
|
| ExclusionCriteria |
| Details |
1)Patients who have major neurological or psychiatric conditions that may affect cognition (e.g., Parkinson’s disease, Stroke, Schizophrenia)
2)Patients who are unable to comply with the training regimen
3)Patients with visual, vestibular, and auditory impairments
4)Severe orthopaedic impairments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global cognitive function measured using montral cognitive scale
Brain activities measured using Electroencephalogram (EEG)
|
at baseline and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Activities of Daily Living measured by Instrumental activities of daily living scale (IADLS)
Quality of Life measured by Quality of Life in Alzheimer’s Disease
|
at baseline and after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="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
|
AD has become a significant problem for the health system, imposing a heavy burden both financially and psychologically on a global scale. Numerous studies have been done to find out the effects of immersive virtual reality on cognitive impairment in conditions such as Stroke, Parkinson’s disease, Traumatic brain injury, and Mild cognitive impairment, but only a few studies have been done on finding feasibility and role of play activities in AD. To my knowledge there is no study to find the efficacy of IVR training for people suffering from AD. Available literature suggests that no studies have been done on the Indian population which needs further investigation. The main Aim of the study is to assess the effect of Immersive Virtual Training and Cognitive Training on the Global cognitive function, Instrumental activities of daily living (IADL’S), Quality of life (QOL) and Brain activities in patients with mild to moderate Alzheimer’s disease. Participants will be recruited from various hospitals and community centres. Participants will be screened on the basis of inclusion criteria. Whole experimental procedure will be explained and informed consent will be obtained from the participants prior to commencement of the study. Participants will be randomly assigned into 2 Experimental groups and 1 Control group. Data will be taken before and after the completion of training protocol. |