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CTRI Number  CTRI/2025/10/095762 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Creating and Testing a New Tool to Measure How Stroke Survivors Move From One Activity to Another During Recovery 
Scientific Title of Study   Development and Validation of Post-Stroke Functional Transition Scale for assessing Mobility Transitions in Stroke Rehabilitation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonika Girsa 
Designation  PhD Research Scholar 
Affiliation  Galgotias University 
Address  B-320 Department of Physiotherapy School of Allied Health Sciences Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8744005925  
Fax    
Email  sonikaphysio1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nidhi Singh 
Designation  Professor 
Affiliation  Galgotias University 
Address  Room no.B-320 Department of Physiotherapy School of Allied Health Sciences Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7042627025  
Fax    
Email  singh.nidhi@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Sonika Girsa 
Designation  PhD Research Scholar 
Affiliation  Galgotias University 
Address  B-320 Department of Physiotherapy School of Allied Health Sciences Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8744005925  
Fax    
Email  sonikaphysio1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  GALGOTIAS UNIVERSITY  
Address  Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201, India 
Type of Sponsor  Research institution 
 
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 Surekha Dabla  Pt. B.D. Sharma Post Graduate Institute of Medical Sciences  Room no. 130,Neurology OPD, New Building, Neurology Department
Rohtak
HARYANA 		 8076941348

surekhadabla@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinically confirmed ischemic or primary intracerebral hemorrhagic stroke (non-traumatic).
Post-stroke duration between 2 weeks and 12 months from onset.
Able to maintain unsupported sitting balance for more than 30 seconds
Cognitive status: Able to understand and follow one-step verbal commands.
6Medically stable and cleared for participation in rehabilitation by a physician.
Willing and able to provide written informed consent.
 
 
ExclusionCriteria 
Details  Severe cognitive or communication impairment
Severe comorbidities affecting mobility
Severe cardiopulmonary disease
Other neurological disorders that may confound motor performance
Unstable medical condition
Severe sensory deficits affecting mobility
Patients with subarachnoid hemorrhage, subdural or epidural hematoma, traumatic intracranial hemorrhage, or traumatic brain injury.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development and validation of Post stroke functional transition scale for assessing functional transitions during stroke rehabilitation  baseline and one month 
 
Secondary Outcome  
Outcome  TimePoints 
Responsiveness of Post stroke functional transition scale to rehabilitation changes.  Baseline and 2 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/11/2025 
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="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   The study focuses on developing and validating the Post Stroke Functional Transition Scale (PFTS) to assess mobility transitions in stroke rehabilitation. Stroke is a leading cause of long term disability and there is currently no standardized tool to evaluate functional transitions such as moving from sitting to walking. The aim of the research is to create and validate PFTS to guide targeted rehabilitation strategies. The methodology involves a prospective cohort study including patients aged 30 to 65 years within three months post stroke. The scale will be developed using expert consensus through the Delphi method, followed by pilot testing and large scale validation. Reliability will be measured using inter rater and intra rater methods, and validity through comparison with existing mobility scales. Expected outcome is that PFTS will provide a reliable and evidence based tool to track progress and improve rehabilitation outcomes for stroke patients. 
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