Elderly population is expected to have balance problems and are at risk of fall. The study will assess the level of balance problems in elderly and effects of Wii Fit balance training on these subjects.
Design
A concealed, randomized, double blinded trial with 90 participants enrolled July and August 2018.
Settings and conduct
Study will be conducted at Physical Therapy department of Kulsum International hospital, Islamabad Pakistan. Participants and outcome assessor will be blinded in the study.
Participants/Inclusion and exclusion criteria
Vitally stable, physically independent subjects with age 60 years and above without any systemic, neurological or orthopedic disorders.
Intervention groups
Participants will receive Wii Fit training for 30 minutes three times a week for 8 weeks.
Main outcome variables
Activity balance confidence, Berg balance scale, Timed up and go, Fukuda, Euro 5D, 5L
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180417039344N1
Registration date:2018-07-20, 1397/04/29
Registration timing:prospective
Last update:2018-07-20, 1397/04/29
Update count:0
Registration date
2018-07-20, 1397/04/29
Registrant information
Name
Kiran Khushnood
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441750
Email address
kiran_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-31, 1397/05/09
Expected recruitment end date
2018-08-30, 1397/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Wii Fit training on balance, confidence and quality of life on elderly population
Public title
Wii Fit training in elderly population
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Physically independent individuals above 60 years of age without any serious systemic pathology or recent injury
Vitally stable
Exclusion criteria:
Subjects with any type of neurological or orthopedic disorder
Age
From 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
Before and after provision of intervention in both groups
Actual sample size reached:
83
More than 1 sample in each individual
Actual sample size in each individual:
2
Before and after application of intervention
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be by sealed envelop. Concealed allocation
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee, Kulsum International Hospital, Islamabad
Street address
2020 Kulsum Plaza
City
Islamabad
Postal code
44000
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
KIH-EC-PT-002
Health conditions studied
1
Description of health condition studied
Elderly population
ICD-10 code
geriatrics
ICD-10 code description
Elderly population
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, Fukuda scales will be used for balance assessment
2
Description
Confidence level
Timepoint
before and post 8 weeks of intervention
Method of measurement
Activity balance confidence scale
3
Description
Quality of life
Timepoint
before and post 8 weeks of intervention
Method of measurement
Euro 5D-5L
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Wii Fit balance training
Category
Rehabilitation
2
Description
Control group: Balance training exercises including tandem walking, one leg stance, side ways walking, walking with alternative arm raise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical therapy department, Kulsum International hospital
Full name of responsible person
Riafat Mehmood
Street address
2020 Kulsum Plaza
City
Islamabad
Postal code
44000
Phone
+92 51 8446666
Email
kirankhushnood@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self
Full name of responsible person
Kiran Khushnood
Street address
House 40A, Street 39B, I-9/4
City
Islamabad
Postal code
44000
Phone
+92 51 8464215
Email
kirankhushnood@yahoo.com
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shifa Tammer-e-Millat University, Islamabad
Full name of responsible person
Kiran Khushnood
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jafar Khan Jamali road
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8464215
Email
kirankhushnood@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer-r-Millat university, Islamabad
Full name of responsible person
Kiran Khushnood
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jafar Khan Jamali road
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8464215
Email
kirankhushnood@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Kiran Khushnood
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
zafar khan jamali road, Islamabad
City
Islamabad
Province
Federal
Postal code
44000
Phone
+92 51 8464215
Email
kirankhushnood@yahoo.com
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
Wii Fit training in elderly population; data regarding outcome measures will be shared.
When the data will become available and for how long
After completion to one year post completion
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
Data will be provided to health care professionals specially physical therapists
From where data/document is obtainable
From email Id; kirankhushnood@yahoo.com
What processes are involved for a request to access data/document
by sending an email to email to kirankhushnood@yahoo.com