| CTRI Number |
CTRI/2017/05/008503 [Registered on: 05/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/05/2017 |
| 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 Backward Walking on Balance in Elderly Population |
|
Scientific Title of Study
|
Effect of Retrowalking on Balance in Elderly Population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aafiya |
| Designation |
Student |
| Affiliation |
Nitte University |
| Address |
Nitte University, Department of Neurological Physiotherapy, Nitte Institute of Physiotherapy, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9796111344 |
| Fax |
|
| Email |
afynv786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purushotam Chippala |
| Designation |
Associate Professor |
| Affiliation |
Nitte University |
| Address |
Nitte University, Department of Neurological Physiotherapy, Nitte Institute of Physiotherapy, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purushotam Chippala |
| Designation |
Associate Professor |
| Affiliation |
Nitte University |
| Address |
Nitte University, Department of Neurological Physiotherapy, Nitte Institute of Physiotherapy, Deralakatte, Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala1979@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Nitte University, Department of Neurological Physiotherapy, Nitte Institute of Physiotherapy, Deralakatte, Manglore |
| Type of Sponsor |
Other [] |
|
|
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 |
| Aafiya |
Abhaya Ashram |
Ground floor abhaya ashram ,Assaigoli, Konaje Village, Mangalore, Karnataka, 574199
Dakshina Kannada
KARNATAKA |
9796111344
afynv786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly population who are at risk of fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Conventional Exercises
Education on beneficial effects of these exercises
Total Duration of 30 minutes |
| Intervention |
Experimental Group |
Conventional Exercises
Retrowalking
Total duration of intervention 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
Berg Balance Score more than 21
Mini Mental State Examination more than 21 |
|
| ExclusionCriteria |
| Details |
Individuals with following conditions: Lower limb fracture
Condition that hinders walking
Cardiorespiratory problems
Any neurological disorder affecting balance
Visual impairments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Pre-intervention one month and post intervention at 1st month,second month and third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fall efficacy scale
Dynamic Gait Index |
Pre intervention
Post intervention (1st month, 2nd month, 3rd month) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Retrowalking is believed to have various benefits, one of them being improvement of balance to prevent disability so by incorporating backward walking in the conventional treatment can improve balance in elderly and help them lead a fall free life. Moreover, very few randomized controlled trials were done on effect of retrowalking on balance in elderly population. And there is dearth of literature for Indian elderly population exist. This has led to need of study. |