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CTRI Number  CTRI/2022/11/047261 [Registered on: 14/11/2022] Trial Registered Prospectively
Last Modified On: 13/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Activity of leg muscle during crossing obstacle in people with stroke 
Scientific Title of Study   Lower limb muscle activity on anticipatory and reactive postural control during obstacle crossing in people post-stroke  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kritagya Malik 
Designation  Post-graduate student 
Affiliation  Manipal college of Health and Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  9711826043  
Fax    
Email  kritagya.malik@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Senthil D Kumaran 
Designation  Associate Professor Sr. Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Details of Contact Person
Public Query  
Name  John M Solomon 
Designation  Associate Professor Sr. Scale ,Head of Department 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Department of Physiotherapy, Manipal College of Health Professions ,Manipal Academy of Higher Education, Manipal Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  9945670671  
Fax    
Email  john.solomon@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, MAHE , Manipal, Karnataka 576104 
Type of Sponsor  Other [MAHE Student seed money] 
 
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 
Kritagya Malik  Neuro-Physiotherapy OPD  Kasturba hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 9711826043

kritagya.malik@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 ((Student Research))  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Obstacle crossing in people with stroke  Lower limb muscle activity on anticipatory (stepper) and reactive (remote control car) postural control while obstacle crossing in people post-stroke  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Participant diagnosed with stroke
2. Self-paced walking without a walking aid or orthosis
3.Berg Balance Score – 41 to 56

 
 
ExclusionCriteria 
Details  1.Participants with visual field defect
2.Hemineglect
3.Global Aphasia
4.Presence of local infections, wounds or ulcers in the lower limb or foot region
5.other co-morbidities that interfered with walking or motion sickness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
% maximum voluntary contraction of muscles
 		 1 (after each task)
 
 
Secondary Outcome  
Outcome  TimePoints 
Balance perception score

 		 1 (immediately after the task) 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/11/2022 
Date of Study Completion (India) 24/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Study approval will be obtained from Institutional Research Committee (IRC), MCHP Ethical clearance is obtained from Institutional Ethics Committee (IEC), Kasturba Hospital, Manipal, after obtaining approval, the study will be registered under the Clinical Trial Registry- India (CTRI), Screening of people with stroke admitted in Kasturba Hospital, Manipal and those visiting Physiotherapy and Neurology OPDs. selection of participants would be made on the basis of inclusion and exclusion criteria. Identified Potential Participants will be explained the study procedure in detail and written consent will be obtained for their participation in the study.  Detailed history and demographic data will be recorded, and Baseline assessment using Fugl Meyer LE, and Berg Balance component will be done. Anthropometric characteristics will be measured before the gait analysis (Height, Leg length, and body weight) will be noted, Before the placement of the electrodes, the area around the muscles will be cleaned with alcohol and surgical tape will be used as appropriate around the electrode and amplifier to obtain better EMG signals. Subjects will be asked to have enough rest, Then will be instructed to walk at a self-selected speed with comfortable shoes along away. Surface EMG electrodes will be placed over the muscle mass of  the Biceps Femoris, Rectus Femoris, Tibialis Anterior, and Gastrocnemius Medialis. Participants will be instructed to walk at a self-selected speed 8m walkway with height adjusted obstacle kept midway. 2ND Time participants will be asked to walk at a self-selected speed 8m walk away where the remote-control car (obstacle) will be left in the way. Each activity will be performed for 3 trials and EMG ( raw muscle activity ) will be recorded for each condition. Muscle activation in RMS, Co-activation index, and Power Spectrum Analysis,  will be calculated during all tasks. Data Analysis will be done
 
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