| CTRI Number |
CTRI/2025/06/089397 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| 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
|
Effects of Brain Training and Balance Exercises on Memory and Stability in Older Adults |
|
Scientific Title of Study
|
Effectiveness of Computer Based Cognitive and Balance Board Training on Cognition and Static Balance in Elderly |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saif Ahmed |
| Designation |
Post Graduate Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Room No.5, Rehabilitation Centre, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9891471757 |
| Fax |
|
| Email |
saifahmed1714@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 545, 5th Floor, Central Library Building, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachi.tiwari@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 545, 5th Floor, Central Library Building, Department of Physiotherapy, SNSAH, Jamia Hamdard, New Delhi
DELHI
110062
India |
| Phone |
9811644726 |
| Fax |
|
| Email |
prachi.tiwari@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, Hamdard Nagar, New Delhi - 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi - 110062 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prachi Tiwari |
Jamia Hamdard |
Room No.5, Rehabilitation Centre, Department of Physiotherapy, Jamia Hamdard
South
DELHI |
9811644726
prachi.tiwari@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric Population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer Based Cognitive and Balance Training Program |
1. Cognitive Training using Computer based cognitive tasks using Lumosity software.
2. Balance Training using Wobble board exercises with sensor based feedback for static balance.
Frequency is 3 sessions per week and 50 minutes per session. |
| Comparator Agent |
Conventional Intervention Program |
Cognitive tasks which include
1. Card matching
2. Backward counting
3. Mental arithmetic
4. Spelling names backward
5. Remembering images, shapes, colors, etc.
Balance tasks which include
1. Marching
2. Stepping over a bench
3. Sit-to-stand exercises with arms folded
4. Heel-to-toe walking
Frequency: 20 repetitions of each task and 50 minutes per session
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to understand and follow simple instructions.
2. Mini Mental State Examination MMSE score between 19 and 23 indicating mild cognitive impairment.
3. Ability to stand independently without assistive devices.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a presence of visual impairment that may interfere with participation.
2. Subjects diagnosed with severe cardiovascular or respiratory conditions.
3. Subjects with a presence of musculoskeletal disorders affecting the lower limbs.
4. Subjects with a history of neurological disorders such as seizures, multiple sclerosis or Parkinsons disease.
5. Subjects with MMSE score between 0 and 18, indicating moderate to severe cognitive impairment.
6. Subjects currently receiving any form of rehabilitative treatment.
7. Subjects using assistive devices for mobility.
8. Subjects with a history of limb amputation.
9. Subjects with uncooperative behavior or inability to comply with study procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mini Mental State Examination
2.Modified Clinical Test of Sensory Interaction in Balance |
Pre intervention, After 4 weeks and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/07/2025 |
| 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="6"
Days="15" |
|
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
|
A
total of 30 elderly participants will be recruited through convenience sampling
based on predefined inclusion and exclusion criteria. Written informed consent
will be obtained after explaining the study’s objectives, procedures, and
potential benefits. All participants will undergo a pre-intervention assessment
comprising demographic details, cognitive evaluation using the Mini-Mental
State Examination, and balance assessment using the Modified Clinical
Test of Sensory Interaction in Balance. Participants will then be
randomly allocated into two groups. Group A will receive an 8 week intervention
consisting of computer based cognitive training using Lumosity software and
balance board training with sensor based feedback, conducted three times per
week for approximately 50 minutes per session. Group B will receive
conventional cognitive exercises and
traditional balance exercises for 50
minutes per session. Outcome assessments will be repeated at Week 4 and Week 8 using the same tools. Collected data will be
analyzed to determine the effectiveness of the intervention on cognitive
function and static balance.
|