| CTRI Number |
CTRI/2025/08/093564 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of Physical Cognitive Dual Task Training versus Conventional Single Task Training on Balance and Quality of Life among Older Adults |
|
Scientific Title of Study
|
"Effects of Phvsical Cognitive Dual Task Training versus Conventional Single Task training on Balance and Quality of Life among 0lder Adults - A Quasi Experimental Study." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha Yadav |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Sector 17-A, Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Department of Physiotherapy, SAHS
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711147463 |
| Fax |
|
| Email |
meghayadav1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urvashi Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Galgotias University |
| Address |
Sector 17-A, Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Department of Physiotherapy, SAHS
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7982938301 |
| Fax |
|
| Email |
urvashurvi299@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urvashi Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Galgotias University |
| Address |
Sector 17-A, Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Department of Physiotherapy, SAHS
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7982938301 |
| Fax |
|
| Email |
urvashurvi299@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Urvashi Sharma PT |
Galgotias University |
Sector-17A, Yamuna Expressway, Greater Noida, Distt. Gautam Budh Nagar Uttar Pradesh, (India), Physiotherapy OPD,203201
Gautam Buddha Nagar
UTTAR PRADESH |
7982938301
urvashurvi299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
Patients will undergo dual task training for 6 weeks, 3 sessions per week, each session lasting 40 minutes. |
| Comparator Agent |
Single Task Training |
Patients will undergo single task training for 6 weeks, 3 sessions per week, each session lasting 40 minutes. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Community dwelling older adults aged 55-65 years who are able to walk independently with or without assistive device, having MMSE score 24 or greater and BBS score 21-30 and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Individuals with severe cognitive impairment MMSE less than 24, neurological and musculoskeletal problems which affects balance and walking, Cardio-vascular Instability, Hearing and vision impairments
Psychiatric patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale (BBS)
Older People’s Quality of Life (OPQOL) |
At the baseline and at the end of 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
04/09/2025 |
| 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="1"
Days="12" |
|
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
|
This Quasi-Experimental study evaluates the effectiveness of physical cognitive dual task training and conventional single task training on balance and quality of life among older adults. Participants will receive either dual task training or single task training for 6 weeks and 3 sessions per week and outcomes will be assessed pre and post intervention. Aim of the study :- To compare the effectiveness of Physical Cognitive Dual Task Training and Conventional Single Task Training for Balance and Quality of Life among Older Adults. INCLUSION CRITERIA:
1. Age group: 55 –65 years.
2. Mini-mental state examination (MMSE) score of 24 or greater.
3. Berg balance scale (BBS) score of 21-30.
4. Able to understand verbal commands.
5. Able to walk without any assistive devices.
EXCLUSION CRITERIA:
1. Neurological problems which affects balance and walking.
2. Musculoskeletal problems which affects balance and walking.
3. Cardio-vascular Instability.
4. Hearing and vision impairments.
5. Psychiatric patients. INTERVENTION:
66 participants will be selected according to inclusion and exclusion criteria and divided into two groups – Group 1 and Group 2.
Group 1 received physical motor-cognitive dual-task training;
Group 2 received single-task motor training.
Outcome measures will be measured by Berg Balance Scale (BBS) and Older People’s Quality of Life (OPQOL). |