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CTRI Number  CTRI/2024/01/061860 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of computer based step exercise on balance and quality of life in elderly. 
Scientific Title of Study   Effect of Nintendo Wii Stepping Exercise on Balance and Quality of Life among Elderly Population. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RICHA JHA 
Designation  Student (Masters of Physiotherapy) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Neuro-physiotherapy lab, 2nd Floor, ISIC Hospital, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8851430944  
Fax    
Email  richajha902@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RICHA JHA 
Designation  Student (Masters of Physiotherapy) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Neuro-physiotherapy lab, 2nd Floor, ISIC Hospital, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8851430944  
Fax    
Email  richajha902@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RICHA JHA 
Designation  Student (Masters of Physiotherapy) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Neuro-physiotherapy lab, 2nd Floor, ISIC Hospital, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8851430944  
Fax    
Email  richajha902@gmail.com  
 
Source of Monetary or Material Support  
Neuro-physiotherapy lab, 2nd Floor, ISIC Hospital, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070  
 
Primary Sponsor  
Name  None 
Address  None  
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shefali walia  Indian Spinal Injuries Centre  Neuro-physiotherapy lab, 2nd Floor, ISIC Hospital, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070.
South
DELHI 
9891770151

shef0604@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries CentreInstitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Community dwelling elders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  controlled group (walking exercise group)  walking exercise 30 minutes 5 times in week for 4 weeks 
Intervention  Nintendo Wii Stepping Exercise  30 minutes Nintendo Wii Stepping Exercise sessions 5 times per week for 4 weeks 2.5 min stepping exercise over 9 times and 1 minute rest period.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Willing to participate and sign inform consent
Either gender having age group sixty to seventy five years
Able to stand at least for ten minutes without assistance
Able to walk a minimum of six meters without aid
Berg Balance Scale Scores forty one out of fifty six and above
Mini mental state examination score above twenty four
Geriatric Depression Scale score less than five
 
 
ExclusionCriteria 
Details  Any Neurological condition stroke Parkinson’s disease epilepsy Alzheimer disease dementia etc
Any orthopaedic disorder osteoarthritis, rheumatoid arthritis, fracture etc and lower extremity joint pain that limits the participation of subject
Visual problem that impeded their participation. [20]
Hearing problem that limits participation. [11]
Unstable cardiorespiratory condition which may affect training procedure
Unstable diabetes mellitus
Uncontrolled hypertension

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale
Mini Balance Evaluation System Test scale
Time up and go test 
At baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Short Form - 36 quality of life scale  4 weeks 
 
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)   05/02/2024 
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="4"
Days="0" 
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  

Balance refers to an individual ability to maintain their line of gravity within their base of support, it may deteriorate with the natural ageing. Globally, people are living longer as they become older; by 2030, 1 in 6 individuals will be 60 years of age or older. The world’s population is gradually aging as a result of demographic trends. Age-related physiological decline in elderly may result in a decline in balance. Estimates of the prevalence of balance impairment in older persons range from 20% to 50%. 

It has been demonstrated that a variety of balance exercises regime, including resistance with aerobic activities, T-Bow training, balance training, wobble board training, stability ball training, adapted physical activity, and a revolutionary stepping exercise, are effective in improving balance.

In order to retain balance during the critical stage of slipping or tripping, older people commonly use a change-in-support strategy known as stepping which involves adaptive increases and decreases in the base of support. To adjust movement and proactively prevent slipping, such appropriate timed and targeted steps can be started voluntarily. Balance in elderly may benefit greatly from training strategies that emphasize performing precise, quick, and well-directed steps.

Beginning with mats, stepping interventions have evolved and Few proofs that it has been combined with the Nintendo Wii are currently accessible.

Previous studies have found that focused on repetitive training, reality-related training, motivational interventions involving active participation, visual and auditory exercise feedback, goal-oriented training, and task-oriented training are more effective at improving balance ability than general and passive interventions .

Evidence suggests that the Nintendo Wii Fit has a lot of potential to expand as a rehabilitation tool for different population group, Therefore, this research will help us to determine the effect of stepping exercises utilizing with Nintendo Wii among elders to see the effect of training in balance ability which is important age related deteriorating factor among elders.

Subjects will be screened and will enrolled on the basis of inclusion and exclusion criteria. They will be divided into two groups with the help of random allocation software. One group (Experimental 1) will made to perform Nintendo Wii Stepping exercise (placing feet on Wii Board and floor as per the given directions in TV screen) in standing position for 5 times a week for 4 weeks for 30 minutes. Second group will receive balance exercise and walking in a form of pamphlet advised for home.

Outcome Measures will be used for assessment.

•       Time-up and go Test, Mini BEST test, activity-specific balance confidence for balance.

•       Short Form-36 V2 Health survey questionnaire (SF-36) For quality of life.

 
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