| CTRI Number |
CTRI/2024/12/078551 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the effect of Otago Exercise (strength based) program and Task oriented circuit training (task specific) for improving balance in the elder people. |
|
Scientific Title of Study
|
Comparative effect of Otago exercise program versus Task oriented circuit training on balance in elderly. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mishika Joshi |
| Designation |
Postgraduate student |
| Affiliation |
Indian spinal injuries centre - institute of rehabilitation sciences |
| Address |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, 2nd floor, Sector- C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9871632147 |
| Fax |
|
| Email |
mishikajoshiosp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Vijay |
| Designation |
Associate Professor |
| Affiliation |
Indian spinal injuries centre - institute of rehabilitation sciences |
| Address |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, 2nd floor, Sector- C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9910631430 |
| Fax |
|
| Email |
priyanka_vijay02@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mishika Joshi |
| Designation |
Postgraduate student |
| Affiliation |
Indian spinal injuries centre - institute of rehabilitation sciences |
| Address |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, 2nd floor, Sector- C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9871632147 |
| Fax |
|
| Email |
mishikajoshiosp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Sector C, Vasant Kunj , New Delhi, South West, Delhi- 110070, India |
|
|
Primary Sponsor
|
| Name |
N/A |
| Address |
N/A |
| Type of Sponsor |
Other [N/A] |
|
|
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 Priyanka Vijay |
PMR department, Ground floor, Indian Spinal Injuries center |
Sec-C, Vasant Kunj, New Delhi
South West
DELHI |
9910631430
priyanka_vijay02@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Otago Exercise Program |
Otago Exercise Program (strength and balance exercise) will be given for 50 mins per sessions, 3 time times per week for 4 weeks. |
| Comparator Agent |
Task Oriented circuit Training |
Task Oriented circuit Training will be given for 50 mins per sessions, 3 time times per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Person is able to follow single commands, Community balance & Mobility scale should be greater than 85 points, Barthel index should be greater than 91 points and mini mental state examination should be greater than 24 points. |
|
| ExclusionCriteria |
| Details |
Person with affected verbal communication skills, person with diagnosed with any symptomatic orthopedic & cardiac and neuro conditions. person with diagnosed neuro psychiatric disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance using Berg Balance Scale, Walking ability using Timed Up and Go Test |
pre test will be taken before intervention and post test after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aging leads to the decline of balance ability and
posture control ability of elderly, which increases the risk of falls. Balance impairment is common among older adults and estimates of its prevalence range between 20 and 50%. About
300,000 people worldwide die from falls every year. Among different balance training regimens, Otago exercise program and Task Oriented Circuit Training have shown significant improvement in balance in Elderly. We find that both protocols effective in improving balance separately. However, to best of our knowledge, no study has been conducted in order to compare the effectiveness of these two protocols. People will be screened based on inclusion and exclusion criteria. selected people will then be divided into two groups using random allocation software: group A (Otago exercise program) and group B (Task Oriented Circuit Training).There will be pre-intervention assessment. participants will undergo a four week intervention consisting of 3 sessions per week, followed by a post-intervention assessment. The outcome measures will be done by using Berg Balance Scale and Timed Up and Go test. Variation in the pre and post outcome measure will help us to find out which exercise regimen is more effective in improving balance in Elderly. |