| CTRI Number |
CTRI/2024/03/064141 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
This backward walking training will improve balance , stride length and gait speed and it prevents the common cause of fall in elderly population. |
|
Scientific Title of Study
|
Effectiveness of Backward Walking Training In Improving Balance In 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 |
DEEPTHI S |
| Designation |
MPT STUDENT |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of Physiotherapy-OPD
No 1 Ramachandra Nagar
Sri Ramachandra Nagar
Chennai Sri Ramachandra Institute of Higher Education and Research
Department of Physiotherapy-OPD
Chennai TAMIL NADU 600116 India |
| Phone |
8939555735 |
| Fax |
|
| Email |
t0322010@sriher.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
ARAJARAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Physiotherapy-OPD
1, , Ramachandra Nagar Department of Physiotherapy-OPD
1, , Sri Ramachandra Nagar, Chennai TAMIL NADU 600116 India |
| Phone |
9865802903 |
| Fax |
|
| Email |
rajarajeswari@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
ARAJARAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of Physiotherapy-OPD
Sri Ramachandra Institute of Higher Education and Research
Department of Physiotherapy-OPD
Chennai TAMIL NADU 600116 India |
| Phone |
9865802903 |
| Fax |
|
| Email |
rajarajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
Department of Physiotherapy-OPD. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Sri Ramachandra Institute of Higher Education and Research
(Deemed to be University),
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu |
| Type of Sponsor |
Other [No sponsor] |
|
|
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 DEEPTHI S |
Sri Ramachandra Institute of Higher Education and Research |
Department of Physiotherapy-OPD
No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu Chennai TAMIL NADU |
8939555735
t0322010@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students projects DHR/ICMR reg no:EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Special population(Elderly people) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACKWARD WALKING TRAINING |
Backward Walking is trainned for 3metres for Alternative days Total intervention of 8days and Therapist will be Guarding Backside |
| Comparator Agent |
Contol Group |
Tandem Standing
Tandem Walking
Marching Onspot
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Ability to maintain upright standing posture-independedly
2. Oriented and comprehending
3. Berg Balance Scale more than 45/56 scoring should be included |
|
| ExclusionCriteria |
| Details |
1. Shouldn’t have any Orthopedic problems
2. Inability to follow two step command
3. No Vestibular disorder. |
|
|
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
|
8 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dynamic Gait index |
8 days |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
21/03/2024 |
| 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="6" 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 is defined as the ability to maintain an
upright posture during both static and dynamic tasks. Maintaining Balance
involves a complex interaction between intrinsic factors that include
peripheral, visual, and vestibular sensation and muscle factors, as well as the
interplay between the neural network and motor output, that are processed and
mediated centrally. All of these factors are affected by normal aging
processes.The Patterns of muscle use change as an individual ages. Strength and
power decline, and the speed of neural processing and number of sensory
receptors both decrease. These changes result in alterations to both volitional
and reflexive motion because neural processing and sensory receptors are major
contributors to effective control of postural balance. Backward walking
Training to improve stride length and dynamic balance is a more recent
application.Backward walking training is benefited for balance performance
among high risk of fall. It improves training and Rehabilitation compared to
Forward walking,Backward walking training is
recommended toimprove Balance,Stride length,Gait and quality of
life .The participants will be recruited according to the inclusion and
exclusion criteria. Participants will be explained about the procedure of the
study and upon their individual’s willingness informed consent will be
obtained. Later, participants will be alloted into two groups (Interventional
and control group) by random allocation. The participants of interventional
group will be given therapy as backward Walking training for specific metres
and period of 8 day of treatment. Control group will be given conventional
balance exercises such as Marching onspot , tandem standing and tandem walking. Participants will be
expected to follow this protocol for the 2-week time period. The participants will be tested Pre and post
test using the following outcome measure-Berg balance scale, Dynamic gait Index
|