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CTRI Number  CTRI/2025/07/091041 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Factors affecting movement of the weaker arm after stroke during hospital stay  
Scientific Title of Study   Factors influencing the amount of paretic upper limb use during initial hospitalization after stroke  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditya Kumar Singh 
Designation  Post Graduate Student  
Affiliation  Manipal College Of Health Professions, department of Physiotherapy, MAHE, Manipal  
Address  Room number 215, Department of Physiotherapy, second floor, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Madhav Nagar, Udupi, Karnataka - 567104

Udupi
KARNATAKA
576104
India 
Phone  9911130969  
Fax    
Email  aditya.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr John Solomon M  
Designation  Associate Dean  
Affiliation  Manipal College Of Health Professions, department of Physiotherapy, MAHE, Manipal  
Address  Room number 215, Department of Physiotherapy, second floor, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Madhav Nagar, Udupi, Karnataka - 567104

Udupi
KARNATAKA
576104
India 
Phone  9945670671  
Fax    
Email  john.solomon@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Senthil D Kumaran  
Designation  Additional Professor  
Affiliation  Manipal College Of Health Professions, department of Physiotherapy, MAHE, Manipal  
Address  Room number 215, Department of Physiotherapy, second floor, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Madhav Nagar, Udupi, Karnataka - 567104

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Manipal College Of Health Professions  
Address  Room number 215, Department of Physiotherapy, second floor, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Madhav Nagar, Udupi, Karnataka - 567104 
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 
Dr Aditya Kumar Singh   Kasturba Hospital   Dhanvantari ward, 3rd floor, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9911130969

aditya.mchpmpl2024@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: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Patients hospitalized with first occurrence of acute CVA

2)Patients with mild and moderate amount of UL impairment (Brunnstorm grading more than or equal to 3)

3)Patients with the ability to understand and follow commands

4)Medically stable patients

5)Patients admitted in wards

6)Patients with the ability to read and understand Kannada or English language

7)Duration post stroke - 2-14 days post stroke.

8)Cognitively sound patients  
 
ExclusionCriteria 
Details  1)Presence of any orthopedic conditions limiting upper limb movements prior to stroke

2)Presence of any other neurological deficits apart from stroke which limit the quantity of hand use in the patient

3)Restless patient

4)Patient prescribed with upper limb restraints

5)Patients with any prescribed upper limb orthosis


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Activity counts on wrist worn accelerometers of both hands
(data recorded by the devices on the amount of arm use of both hands)  		 3-5 day recordings of wrist worn accelerometers since the time of recruitment
 
 
Secondary Outcome  
Outcome  TimePoints 
Brunnstorm upper limb grading (voluntary control grading)   At time of recruitment 
FMA - The Fugl-Meyer Assessment Upper Extremity (FMA-UE) score   At time of recruitment 
NSA - The Nottingham Sensory Profile score   At time of recruitment 
Modified Kuppuswamy scale   At time of recruitment 
Generalized self-efficacy questionnaire score   At time of recruitment 
The International Physical Activity Questionnaire - Short Form score   At time of recruitment 
Hospital anxiety and depression scale score   At time of recruitment 
Motivation for rehabilitation scale score   At time of recruitment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/08/2025 
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="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  

This cross-sectional study aims to identify physical, psychological, behavioral, demographic, and clinical factors that influence the amount of paretic upper limb use during the initial hospitalization (2–14 days post-stroke) in acute stroke patients. The study uses wrist-worn accelerometers (ActiGraph wGT3X-BT®) to objectively record upper limb activity over 12-hour sessions across weekdays(3-5 weekdays). Participants will also be assessed using standardized outcome measures like the Fugl-Meyer Assessment, Nottingham Sensory Assessment, Hospital Anxiety and Depression Scale, and others.

Patients aged 18–80 years, medically stable, cognitively sound, and able to follow commands, will be included. Data collection will involve activity counts from accelerometers and administration of clinical assessments, followed by univariate and multivariate statistical analysis to determine influential factors.

The study addresses a research gap: limited evidence about early factors affecting arm use during the initial hospital stay after stroke, which is crucial for promoting early recovery and preventing learned non-use.

 
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