| 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
|
|
|
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
|
|
|
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. |