To determine the effect of single task training versus dual task training on balance and cognition in older adults
Design
A concealed, randomized, double blinded trial
Settings and conduct
Study will be conducted at Najjat trust old home Rawalpindi, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: both male and female; age of the participants between 50 years and above; able to walk independently without assistive devices; Mini-Mental State Examination (MMSE) score between 18 to 23; Berg balance scale score less than 50.
Exclusion criteria: participant who had recent history of fall within one year; unstable medical condition; significant visual and auditory impairments; unwillingness for participation in the study; presence of other neurological or musculoskeletal conditions affecting balance.
Intervention groups
Control group: participants will perform functional tasks that require balance like, tandem standing with eyes open and closed, transferring from one chair to another chair, single leg standing on alternate legs, walking with a reduced base of support, obstacle crossing. Participants will perform the training 3 days a week for up to 8 weeks; 5 minutes warm up followed by 30 minutes training session and 5 minutes cool down.
Treatment group: participants will perform balance tasks like, tandem standing with eyes open and closed, transferring from one chair to another chair, single leg standing on alternate legs, walking with a reduced base of support, obstacle crossing simultaneously with cognitive task. Participants will perform the training 3 days a week for up to 8 weeks; 5 minutes warm up followed by 30 minutes training session and 5 minutes cool down.
Main outcome variables
Berg balance scale; Time up and go test; Mini Mental State Examination; Montreal Cognitive Assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210909052419N1
Registration date:2021-09-19, 1400/06/28
Registration timing:registered_while_recruiting
Last update:2021-09-19, 1400/06/28
Update count:0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Hafsah Gul Khattak
Name of organization / entity
University of Lahore, Islamabad campus
Country
Pakistan
Phone
+92 51 4509595
Email address
hafsah.gul@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-02, 1400/02/12
Expected recruitment end date
2021-10-30, 1400/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF SINGLE TASK TRAINING VERSUS DUAL TASK TRAINING ON BALANCE AND COGNITION IN OLDER ADULTS
Public title
EFFECTS OF SINGLE TASK TRAINING VERSUS DUAL TASK TRAINING ON BALANCE AND COGNITION IN OLDER ADULTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female participants of age 50 years and above
Able to ambulate independently walk without assistive devices
Mini-Mental State Examination (MMSE) score between 18 to 23
Berg balance scale score less than 50
Exclusion criteria:
Participant who had recent history of fall within one year
Unstable medical condition
Significant visual and auditory impairments
Presence of other neurological or musculoskeletal conditions affecting balance
Unwillingness for participation in the study
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly divided into 2 groups (experimental and control group) by sealed envelope method using convenient sampling technique and informed consent will be taken from each patient who willing to participate in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants of both control and experimental group as well as the person who will assess the outcomes before and after application of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of University Institute of Physical Therapy University of Lahore.
Street address
6.7 Km Japan road, Sihala zone-5
City
Islamabad
Postal code
44000
Approval date
2021-04-15, 1400/01/26
Ethics committee reference number
UOL/UIPT/ IRB/EC/000100
Health conditions studied
1
Description of health condition studied
Balance and cognition in older adult
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Before intervention and after 8 weeks post intervention.
Method of measurement
Berg balance scale, Timed up and go test.
2
Description
Cognition
Timepoint
Before intervention and after 8 weeks post intervention.
Method of measurement
Mini mental state examination , Montreal Cognitive Assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dual task training group participants will perform balance tasks like, tandem standing with eyes open and closed, transferring from one chair to another chair, single leg standing on alternate legs, walking with a reduced base of support, obstacle crossing simultaneously with cognitive task. Participants will perform the training 3 days a week for up to 8 weeks; 5 minutes warm up followed by 30 minutes training session and 5 minutes cool down.
Category
Rehabilitation
2
Description
Control group: Single task training group participants will perform functional tasks that require balance like, tandem standing with eyes open and closed, transferring from one chair to another chair, single leg standing on alternate legs, walking with a reduced base of support, obstacle crossing. Participants will perform the training 3 days a week for up to 8 weeks; 5 minutes warm up followed by 30 minutes training session and 5 minutes cool down.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Najjat trust old home
Full name of responsible person
Dr. Yaqoob Malik
Street address
P-330, Janglat Road, Banni
City
Rawalpindi
Postal code
46000
Phone
+92 51 5165304
Email
hafsah.gul@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self
Full name of responsible person
Hafsah Gul Khattak
Street address
House 31A, Street 9B, G-9/4
City
Islamabad
Postal code
44000
Phone
+92 51 5470215
Email
hafsah.gul@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University Institute of Physical Therapy University of Lahore, Islamabad campus, Pakistan
Full name of responsible person
Hafsah Gul Khattak
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
6.7 Km Japan road, Sihala zone-5
City
Islamabad
Province
Federal
Postal code
440000
Phone
+92 51 4509595
Email
hafsah.gul@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University Institute of Physical Therapy University of Lahore, Islamabad campus
Full name of responsible person
Hafsah Gul Khattak
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
6.7 Km Japan road, Sihala zone-5
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 4509595
Email
hafsah.gul@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore, Islamabad campus, Pakistan
Full name of responsible person
Hafsah Gul Khattak
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ibn e Sina Road, Islamabad
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 4509595
Email
hafsah.gul@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effect of single task training versus dual task training on balance and cognition in older adults; data regarding outcome measures will be shared.
When the data will become available and for how long
After the publication of the study.
To whom data/document is available
for research and clinical purposes to healthcare
professional working in academic and clinical settings
Under which criteria data/document could be used
On informed request from the investigators
From where data/document is obtainable
via email
What processes are involved for a request to access data/document