| 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
|
|
|
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
|
|
|
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. |