Protocol summary

Study aim
• To assess the effectiveness of Dual task training vs Nintendo Wii-fit among older adults. • To compare the quality of life and physical performance among the older adults in both groups
Design
All participants will be informed about the study and signed written informed consent before interventions. Participants for the study will be recruited from well-known older homes of Islamabad and Rawalpindi. All patients will come about into two groups the experimental group 1 and experiment group 2, keeping the process completely randomized (sealed envelope method will be used
Settings and conduct
Nijat Trust treatment center in Rawalpindi In this study simple random sampling technique is used by sealed envelop method
Participants/Inclusion and exclusion criteria
Inclusion criteria: o Both male and female above 60 yrs. o Able to stand , no use of walking device o Mini mental status Examination those who scored more than 24 will be enrolled in study o Berg balance range 52 or less points out of 56 will be included 9 o Ability to walk 10m without the assistance of another person; Exclusion criteria: o Psychiatric disorder, inability to walk. o Who were unable to ambulate without assistive devices o Musculoskeletal impairment/injury o Medical conditions and medication affecting
Intervention groups
There are 2 groups DTT group (Dual task training ) and NWT group (Nintendo Wii-fit group) 0
Main outcome variables
Berg balance scale, Time up and go.Physical performance test , SF-36 survey, The Activities-Specific Balance Confidence (ABC) Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211022052835N3
Registration date: 2022-02-14, 1400/11/25
Registration timing: prospective

Last update: 2022-02-14, 1400/11/25
Update count: 0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-25, 1400/12/06
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Dual task training vs Nintendo Wii-fit to improve balance among older adults
Public title
Effectiveness of Dual task training vs Nintendo Wii-fit to improve balance among older adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female above 60 yrs. Able to stand , no use of walking device Mini mental status Examination those who scored more than 24 will be enrolled in study Berg balance range 52 or less points out of 56 will be included Ability to walk 10m without the assistance of another person;
Exclusion criteria:
Psychiatric disorder, inability to walk. Who are unable to ambulate without assistive devices Musculoskeletal impairment/injury Medical conditions and medication affecting
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the older adult for their participation in the study, the therapist opens the envelop and give the respective protocol to the individual. The study is single blinded as participants is not aware of the intervention group they are placed in. Elders will be placed either in to the experimental group 1 (Dual task training DTT) or experimental group 2 (NWF Nintendo Wii-fit) keeping the process completely randomized ,sealed envelope method will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to collecting data, participants would be informed about both the treatment techniques used in both groups; experimental group A (DDT) and experimental group B (NWF). Further they are informed that you will get one of these treatment depending upon the group written on the card inside the envelop you choose. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board & Ethics Committee (IRB & EC) Shifa International Hospital Ltd. (SIH), Sh
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44790
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IRB#301-21

Health conditions studied

1

Description of health condition studied
Unsteadiness on feet, Difficulty in balancing
ICD-10 code
R26.81
ICD-10 code description
Unsteadiness on feet

Primary outcomes

1

Description
Balance
Timepoint
Before intervention, 4, 8 week after intervention
Method of measurement
Berg balance test, Time up and go test, Activities-Specific Balance Confidence (ABC) Scale

Secondary outcomes

1

Description
Physical performance
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
Physical performance tests for measuring multiple domains of physical function

2

Description
Quality of life
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
SF-36

Intervention groups

1

Description
Intervention group: Intervention for DDT group:• Week 1-6 (30 – 40minutes )• Warm up 5mintues • Balance training • Dynamic weight shifting , shifting with eyes • Closed/open ,transfer , standing static/• Dynamic , internal and external perturbations with timing and speed , • Reaching and walking forward and backward, tandem sideways walk , up and down stairs (plain and foam obstacles) • Week 6-12 (30-40minutes)• Dual task walking with subtraction n addition • Placing pencil in holes of covered cup , • Walking with fully filled glass of water , transferring objects at different heights , walking with Toss a ball from one hand to the other• Bounce a ball
Category
Rehabilitation

2

Description
Intervention group: Intervention for NWT group • Week 1-6 30 minutes • Warm up for 5 minutes • Soccer heading game• Yoga tree pose (once)• Week 6-12 10+10+10 minutes• Soccer heading• Ski slalom• Table tilt• Yoga tree pose (3 times)
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Nijat Trust treatment center in Rawalpindi
Full name of responsible person
Mehak Kiran
Street address
P-330, Janglat Road، Banni, Rawalpindi,
City
Rawalpindi
Postal code
46000
Phone
+92 51 5542000
Email
mehakfaizan46@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Fouzia Batool
Street address
Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad
City
Islamabad
Postal code
44000
Phone
+92 332 7120385
Email
fouzia_dpt.ahs@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shifa Tameer-e-Millat University
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
Shifa Tameer-e-Millat University
Full name of responsible person
Fouzia Batool
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 332 7120385
Email
fouzia_dpt.ahs@stmu.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Fouzia Batool
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 332 7120385
Email
fouzia_dpt.ahs@stmu.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Shifa Tameer-e-Millat University
Full name of responsible person
Fouzia Batool
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Pitras Bukhari Road, H-8/4, Shifa Tameer-e-Millat University, Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 8441752
Fax
Email
fouzia_dpt.ahs@stmu.edu.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
There is no such plan
When the data will become available and for how long
There is no such plan
To whom data/document is available
There is no such plan
Under which criteria data/document could be used
There is no such plan
From where data/document is obtainable
There is no such plan
What processes are involved for a request to access data/document
There is no such plan
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