| CTRI Number |
CTRI/2023/11/060319 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Live v/s video action observation for improving balance and cognition in elderly. |
|
Scientific Title of Study
|
Effect of Action Observation Live And Action Observation Video On Balance And Cognition In Elderly - A Randomised 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 |
Nishi Jain |
| Designation |
Pg student |
| Affiliation |
Amar Jyoti Institute of physiotherapy (University of Delhi) |
| Address |
Neuro OPD, 3rd floor Amar Jyoti Rehabilitation and Research Centre
Karkardooma, Vikas Marg, Delhi -92
East
DELHI
110092
India |
| Phone |
9911159611 |
| Fax |
|
| Email |
jain.nishi611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sampada jhagirdar |
| Designation |
Assistant professor |
| Affiliation |
Amar Jyoti Institute of physiotherapy (University of Delhi) |
| Address |
Neuro OPD, 3rd floor, Amar Jyoti Rehabilitation and Research Centre
Karkardooma, Vikas Marg, Delhi -92
East
DELHI
110092
India |
| Phone |
9810991128 |
| Fax |
|
| Email |
s.jahagirdar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nishi Jain |
| Designation |
Pg student |
| Affiliation |
Amar Jyoti Institute of physiotherapy (University of Delhi) |
| Address |
Neuro OPD, 3rd floor,Amar Jyoti Rehabilitation and Research Centre
Karkardooma, Vikas Marg, Delhi -92
East
DELHI
110092
India |
| Phone |
9911159611 |
| Fax |
|
| Email |
jain.nishi611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti institute of physiotherapy, Vikas Marg karkardooma Delhi-92 |
|
|
Primary Sponsor
|
| Name |
Nishi Jain |
| Address |
Neuro OPD, 3rd floor Amar Jyoti institute of physiotherapy, Vikas Marg, karkardooma, Delhi-92 |
| 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 Sampada jhagirdar |
Amar Jyoti institute of physiotherapy |
3rd floor neuro OPD Amar Jyoti institute of physiotherapy
Vikas marg, karkardooma, Delhi -92
East
DELHI |
9810991128
s.jahagirdar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar jyoti institutional review board-ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Action observation therapy live
|
3 session per week for 4 weeks (12 session)
|
| Intervention |
Action observation therapy video |
3 session per week for 4 weeks (12 session ) |
| Comparator Agent |
Dual task therapy |
3 session per week for 4 weeks (12 session) |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.MMSE score 25 or higher
2.Fully independent for activities of daily living, as measured by Barthel index
3.Being able to walk 20m independently without use of walking aid
4.Able to read and write English or Hindi
|
|
| ExclusionCriteria |
| Details |
1.Having any significant neurological, cardiovascular or orthopedic disturbances that might impact their balance and cognition.(such as Stroke, Parkinson’s, epilepsy, recent myocardial infraction, uncontrolled blood pressure, transient ischemic attacks, lower extremity joint replacement, fractures within past 6 months)
2.Having moderate to severe severity levels of depression, defined by a score >9 on the patient health questionnaire – 9 (PHQ-9)
3.Diagnosis of dementia by a neurologist.
4.Dizziness or headache on the assessment day.
5.Uncorrected visual or hearing impairments.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| balance and cognition using Mini BESTest and Trail making test |
At baseline and after 4 weeks (12 session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMSE, Barthel index & patient health questionnaire-9 for the screening of the patients |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2023 |
| Date of Study Completion (India) |
08/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Present study is an interventional study. The purpose of the study is to compare the effect of action observation therapy live and action observation therapy video on balance and cognition in elderly and to explore the efficacy of these techniques in alleviating the age related decline in balance and cognition over conventional dual task therapy among elderly population. Further this study will contribute to the existing literature on observation-based interventions for elderly individuals. By specifically examining the impact of video and live observations on balance and working memory it will enhance the design and implementation of intervention that target these specific domains. Study will be conducted at Amar jyoti institute of physiotherapy (University of Delhi) in Delhi, India. The aim and objectives of the study are to identify the effect of action observation live and action observation video on balance and cognition in elderly and to compare the effect of action observation live and video on balance and cognition. The outcome measures are Mini-BESTest for balance and Trail-making test for cognition. |