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CTRI Number  CTRI/2025/02/079927 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Knowing improvement in hand movement and sensation in patients with one-sided weakness of body 
Scientific Title of Study   Predicting upper limb sensorimotor recovery using data driven models in patients with 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  Siddharth Savadia 
Designation  PhD scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9426228290  
Fax    
Email  siddharth1.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Senthil Kumaran D 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr John Solomon M  
Designation  Associate Dean and Additional Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Karnataka, India, 576104

Udupi
KARNATAKA
576104
India 
Phone  9945670671  
Fax    
Email  john.solomon@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Siddharth Savadia 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education , Manipal, Karnataka, India, 576104 
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 Siddharth Savadia PT  Kasturba Medical College and Hospital  Dhanvatari Ward and Neuromotor Control room, Kasturba Hospital, Manipal, Karnataka, India, 576104
Udupi
KARNATAKA 
9426228290

siddharth1.mchpmpl2023@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  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  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.
 
 
ExclusionCriteria 
Details  1. Individual admitted in hospital after seven days of stroke
2. Individuals who are unable to follow three-step commands and cannot comprehend
3. Individuals who have undergone surgical procedures related to brain
4. Individual with any pre-existing impairment affecting the upper extremity
5. Any other musculoskeletal conditions or significant medical problems or co-morbidities
6 Participants not willing to give consent or Uncooperative
7. Individual with bilateral stroke
8. Individuals with conditions that are restricting the kinematic analysis
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. National Institutes of Health Stroke Scale
2. Motricity index
3. Grip strength
4. Pinch strength
5. Shoulder abduction and finger extension score
6. 3D kinematic analysis of upper limb movement
7. 2D kinematic analysis of upper limb movement
8. Erasmus MC modification of Nottingham Sensory Assessment
9. Hospital Anxiety and Depression Scale (HADS)
10. Montreal Cognitive Assessment (MoCA)
 
Within 7 days post stroke, up to 5 weeks post stroke 
 
Secondary Outcome  
Outcome  TimePoints 
1. Fugl-Meyer Assessment for upper extremity (FMA-UE)
2. Erasmus MC modification of Nottingham Sensory Assessment
3. EQ-5D 
10th-12th week of stroke, 24th to 26th week of stroke  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/02/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 sensorimotor recovery of the upper extremity is an underexplored field, making it complex to develop effective rehabilitation goals and personalized therapy. Predictive models can be crucial in planning rehabilitation strategies, enabling the rehabilitation team to create suitable treatment plans based on these predictions. This prospective cohort study aims to develop and validate data-driven models for predicting upper limb sensorimotor recovery using conventional statistical and machine learning techniques. A physiotherapist will measure the outcome at four different time points, with these outcomes being divided into independent and dependent variables. Newly diagnosed stroke patients admitted to the hospital will be screened for selection criteria, and potential participants will be invited to take part in the study. Those who agree to participate will be informed and asked to provide written consent. Baseline demographic characteristics such as age, gender, dominance, ethnicity, level of education, premorbid status, comorbidities, site and subtype of stroke, CT and MRI findings will be recorded. Assessments, including NIHSS, motricity index, grip, and pinch strength, will be conducted within 7 days of the stroke, along with kinematic analysis of the upper limb functional task. Follow-up sessions will assess dependent variables including motor functions, sensory perception, and quality of life. After data collection, significant factors contributing to predicting sensorimotor recovery will be identified, and a prediction model will be developed and validated.

 
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