| CTRI Number |
CTRI/2023/02/049977 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trail to study the effect of two exercise program, otago exercise versus otago exercise combine with postural control on balance, mobility and fall in young old individual. |
|
Scientific Title of Study
|
Effects of otago exercise versus otago exercise combine with postural control on balance, mobility and fall in young old individual - A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Viral Gareja |
| Designation |
Mater Of Physiotherapy |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Room no. 232, Parul Sevashram Hospital, Parul University, Waghodia Road, Limda, Vadodara
Waghodia Road, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8980701111 |
| Fax |
|
| Email |
viral.k.gareja1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Shah |
| Designation |
Senior Lecturer |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
room no. 232, Parul Sevashram Hospital, Parul University, Waghodia Road, Limda, Vadodara
Waghodia Road, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998107262 |
| Fax |
|
| Email |
cjshah_04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Viral Gareja |
| Designation |
Mater Of Physiotherapy |
| Affiliation |
Parul Institute Of Physiotherapy |
| Address |
Room no. 232, Parul Sevashram Hospital, Parul University, Limda
Waghodia Road, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8980701111 |
| Fax |
|
| Email |
viral.k.gareja1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Physiotherapy, parul University, Limda, Vadodara, Gujrat |
|
|
Primary Sponsor
|
| Name |
Parul Sevashram Hospital |
| Address |
Parul Institute Of Physiotherapy, Waghodia road, Limda, Vadodara |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Viral Gareja |
Parul Institute Of Physiotherapy |
Parul Institute Of Physiotherapy, Waghodia road, Limda, Vadodara
Vadodara
GUJARAT |
8980701111
viral.k.gareja1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Commitee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young old individual |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Otago exercise |
The Otago exercise is specifically designed to improve mobility and balance of an older healthy individual. The 3 sessions were conducted for 4 weeks. |
| Comparator Agent |
Otago exercise combine with postural correction exercise |
The Otago with postural correction was additional technique and given to enhance the postural stability of an healthy individual . The 3 sessions were conducted for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Older age population age above 65-75
2. Cognitive ability to participate as indicated by mini mental state examination score of 24 or higher.
3. The participants who are willing to participate.
4. Both males and females
|
|
| ExclusionCriteria |
| Details |
1. Any neurological disorders such as , stroke, cerebral disorder, Parkinson disease
2. Any severe cardiovascular disorder such as uncontrolled hypertension.
3. Any speech deficits interfering research
4. Unstable seizure disorders
5. Significant hearing and visual impairment
|
|
|
Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
TIME UP AND GO TEST
FALL EFFICASY SCALE
FOUR STAGE BALANCE SCALE |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
FALL EFFICASY SCALE
FOUR STAGE BALANCE SCALE |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/02/2023 |
| 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="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM The aim of this study is to evaluate the effects of Otago exercises versus Otago exercise combine with postural correction on falls, balance, and mobility in old-aged adults with high fall risk. OBJECTIVES To evaluate the effectiveness of Otago exercise on young old age population using timed up and go. To evaluate the effectiveness of Otago exercise on young old age population using fall efficacy scale. To evaluate the effectiveness of Otago exercise on young old age population using four stage balance tests. To evaluate the effectiveness of Otago exercise combined with postural correction on old young age population using timed up and go scale. To evaluate the effectiveness of Otago exercise combined with postural correction on young old age population using fall efficacy scale. To evaluate the effectiveness of Otago exercise combined with postural correction on young old age population using four stage balance tests. To compare the effectiveness of Otago exercise combined with postural correction on young old population. |