| 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
|
|
|
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
|
|
|
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. |