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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 


 
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