| CTRI Number |
CTRI/2025/08/092371 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“EFFECT OF BACKWARD WALKING AND SIDE WALKING TRAINING ON GAIT SPEED AND CADENCE IN STROKE SURVIVORS:
A SINGLE GROUP EXPERIMENTAL STUDY” |
|
Scientific Title of Study
|
Impact of Backward and Side Walking Training on Gait speed and cadence in Stroke Survivors: A Single-Group Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmitha K S |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy |
| Address |
MPT Classroom one, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
MPT Classroom one, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
6363830234 |
| Fax |
|
| Email |
nirmithaks67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh M |
| Designation |
Associate professor |
| Affiliation |
cauvery college of physiotherapy |
| Address |
Department of neuro,cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Department of neuro, cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
7795771545 |
| Fax |
|
| Email |
rakeshmanju098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirmitha K S |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy |
| Address |
MPT Classroom one, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
MPT Classroom one, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
6363830324 |
| Fax |
|
| Email |
nirmithaks67@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD cauvery college of physiotherpy KBL layout near deve gowda circle mysore karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Nirmitha K S |
| Address |
Cauvery college of physiotherapy , KBL layout near devegowda circle mysore |
| Type of Sponsor |
Other [private college ] |
|
|
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 |
| Nirmitha K S |
OPD cauvery college of physiotherapy |
Department of neuro, cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
MPT Classroom one, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA |
6363830324
nirmithaks67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee cauvery heart and multispeciality hospital, mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
STROKE SURVIVORS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
backward and side walking training |
backward walking training is given for 15 min and side walking training is given for 15 min and 10 min rest, 3 days a week for 3 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both the genders were included for the study
Age group 35 to 65 years
Patient who had stroke for 6 months and more
Mini Mental State Examination score of at least or more than 25 point
Patient should be able to walk at least 10 meters with or without walking aid or
orthosis
Modified Ashworth Scale one, one plus and two |
|
| ExclusionCriteria |
| Details |
Subjects unable to follow the commands
Patients having cognitive, perceptual, cardio respiratory abnormalities and other
orthopaedic problems of lower limb were also excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 10 meter walk test |
before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| kinovea software version 2023.1.2 |
before & after intervention |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
16/08/2025 |
| 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="1"
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
|
This study will aim to evaluate the effects of backward walking training and side walking training on gait speed and cadence in individuals who have had a stroke. Stroke survivors will commonly experience gait impairments such as reduced walking speed and altered cadence which will hinder their functional mobility and independence. Traditional rehabilitation will predominantly emphasize forward walking, but this study will explore the potential benefits of multidirectional gait training as a novel approach. A single group experimental design will be used participants will undergo a structured program involving BWT and SWT. Gait speed and cadence will be measured using the 10 Meter Walk Test before and after the intervention. Objective motion analysis will be conducted using Kinovea software in order to enhance the accuracy of the gait assessment. |