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CTRI Number  CTRI/2024/11/077420 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Immediate Effects of Sideways Walking on Treadmill on Reaction Time and Balance in Older Adults 
Scientific Title of Study   Immediate effect of Sideways treadmill task on Reaction time, Response Inhibition and Accuracy of side-stepping strategy in Older adults  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavita P Pawar 
Designation  Post Graduate Student 
Affiliation  Ramaiah College of Physiotherapy  
Address  Ramaiah Medical College and Hospital, Department of Physiotherapy, 3rd floor, Library, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  7349094848  
Fax    
Email  kavitapawarwork@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramesh Debur 
Designation  Associate Professor 
Affiliation  Ramaiah College of Physiotherapy 
Address  Ramaiah Medical College and Hospital, Department of Physiotherapy, 3rd floor, Staff Room, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9845544848  
Fax    
Email  rameshdebur.rcp@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Ramesh Debur 
Designation  Associate Professor 
Affiliation  Ramaiah College of Physiotherapy 
Address  Ramaiah Medical College and Hospital, Department of Physiotherapy, 3rd floor, Staff Room, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054

Bangalore
KARNATAKA
560054
India 
Phone  9845544848  
Fax    
Email  rameshdebur.rcp@msruas.ac.in  
 
Source of Monetary or Material Support  
Ramaiah Medical College and Hospitals, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054 
Ramaiah Memorial Hospital, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore-560054 
 
Primary Sponsor  
Name  Kavita P Pawar 
Address  Ramaiah College of Physiotherapy, New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore- 560054  
Type of Sponsor  Other [self] 
 
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 
Kavita P Pawar  Center for Rehabilitation, Ramaiah Memorial Hospital  New BEL Road, M S Ramaiah Nagara, MSRIT Post, Bangalore- 560054
Bangalore
KARNATAKA 
7349094848

kavitapawarwork@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M S Ramaiah Medical and Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  elderly 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Sideways treadmill task  Sideways walking progresses in mediolateral direction rather than anteroposterior which usually happens in forward walking. Hip abduction and hip adduction are main components of this novel gait. .A warmup session of 10 minutes of side walking on treadmill will be done only on one side. If the participant fails to achieve 50% of gait speed in the warmup session, then the participant is excluded from the study. The participants who achieve 50% of gait speed will be included for the next 10 minutes of sideways treadmill training on the same side. Vitals will be assessed and rests will be provided accordingly  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Community ambulators without any assistive device
2. Mini Cog score 3 to 5
3. Tug score less than 14 sec
 
 
ExclusionCriteria 
Details  1. Diagnosed balance dysfunctions such as Vertigo.
2. History of cardiac arrest and underwent heart surgeries such as CABG.
3. Diagnosed cardiovascular diseases like coronary artery disease and triple vessel disease and congenital heart diseases.
4. Diagnosed cognitive impairment such as Dementia and Alzheimer disease.
5. Diagnosed Neurological conditions such as Parkinson disease and
Stroke and Fibromyalgia.
6. Diagnosed Musculoskeletal conditions such as chronic pain of
lower limb.
7. Diagnosed psychiatric illness such as bipolar disorder.
8. Severe medical illness likely to interfere with study
participants.
9. Significant vision or hearing impairment limiting study
evaluation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Go/No-Go paradigm  For assessing reaction time, response inhibition and accuracy of side stepping strategy Go/No-Go paradigm will be used.
Pre and post sideways treadmill task Go/No-Go paradigm will be used. 
 
Secondary Outcome  
Outcome  TimePoints 
gait speed  pre and post the intervention gait speed will be assessed 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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)   20/12/2024 
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="1"
Months="0"
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  
A fall is an unintentional event where a person ends up on the ground or another lower level. Internal perturbations are voluntary movements that alter the position of one or more body segments, potentially disrupting posture and balance. A video analysis found that 41% of falls among older adults in long-term care were due to inappropriate weight shifts, typically occurring when individuals attempted to quickly adjust during self-imposed changes in planned movements. Response inhibition, or inhibitory control, refers to the ability to regulate attention, behavior, thoughts, or emotions to override impulsive responses and instead act in a more appropriate or needed way. This can be assessed using a Go/No-Go paradigm. Older adults often struggle with response inhibition, which leads to difficulties stopping incorrect movements and selecting appropriate stepping strategies. This challenge may stem from changes in how older adults process stimuli and plan movements, contributing to delayed reaction times. Overground sideways walking has been shown to improve walking speed, reduce timed up-and-go scores, and lessen the fear of falling in healthy older adults, but it reduces the occurrence of anticipatory postural adjustments and stepping task planning. Treadmill training, on the other hand, activates the central gait pattern generator and enhances motor learning, but it doesn’t provide opportunities for APA, making step responses more reliant on higher-order cognitive processes. There is limited research on using treadmill training to assess or improve response inhibition, and even less on its use for improving perturbation performance. This study aims to use treadmill tasks to enhance perturbation responses.
 
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