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CTRI Number  CTRI/2020/12/030144 [Registered on: 31/12/2020] Trial Registered Prospectively
Last Modified On: 12/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to determine if exercises involving daily tasks improve arm and hand function in those who had stroke recently.  
Scientific Title of Study   Effect of Task-Oriented Training on Upper Extremity Function in Acute Stroke Subjects: An Experimental Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aashish Nepal 
Designation  MPT student 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Institute of Physiotherapy, Narayana Hrudayalaya Foundations, Narayana Health City, Hosur road, Bangalore
Sidappa M, near Mahadevamma Temple, Hennagara Main Road, Kithiganahalli, Bommasandra Industrial Area, Anekal Taluk
Bangalore
KARNATAKA
560099
India 
Phone  7483488921  
Fax    
Email  aashishnep1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smruti Swagatika Dash 
Designation  Associate Professor 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Institute of Physiotherapy, Narayana Hrudayalaya Foundations, Narayana Health City, Hosur road, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9448552026  
Fax    
Email  smruti.dash@hrudayalayafoundation.org  
 
Details of Contact Person
Public Query  
Name  Aashish Nepal 
Designation  MPT student 
Affiliation  Narayana Hrudayalaya Institute of Physiotherapy 
Address  Narayana Hrudayalaya Institute of Physiotherapy, Narayana Hrudayalaya Foundations, Narayana Health City, Hosur road, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  7483488921  
Fax    
Email  aashishnep1996@gmail.com  
 
Source of Monetary or Material Support  
Aashish Nepal, Narayana Hrudayalaya Institute of Physiotherapy, Narayana Hrudayalaya Foundations, Narayana Health City, Hosur road, Bangalore, Karnataka 560099 
 
Primary Sponsor  
Name  Narayana Hrudayalaya Ltd 
Address  258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur road, Bangalore, Karnataka 560099 
Type of Sponsor  Research institution and hospital 
 
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 
Aashish Nepal  Mazumdar Shaw Medical Center  Neurology ward, 2nd floor, Mazumdar Shaw Medical Center, Narayana Health City, 258/A, Bommasandra Industrial Area, Anekal Taluk, Hour road, Bangalore, Karnataka, 560099
Bangalore
KARNATAKA 		 07483488921

aashishnep1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee (NHAEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  i. Positioning ii. Stretching and ROM exercises (PROM/AAROM/AROM). iii. PNF patterns for both upper and lower extremities. iv. Bed mobility training and transfers. v. Ambulation with support. vi. Bronchial hygiene and chest physiotherapy. 
Intervention  Task oriented training (TOT)  Task-oriented training (TOT) also referred as task-based, task-related, activity-based or goal-oriented training which is a clinical therapeutic approach that induces cortical reorganization based on rehabilitation science, grounded in the principles of motor learning, motor control and neuroplasticity. It highlights the importance of active participation and skill acquisition for patient’s recovery. It is recognized that ‘movement emerges from the interaction between the individual, the task and the environment. Therefore, it can also be defined as “repetitive, functional purposeful movement for a specific task in order to improve physical impairments and maximize functional performance abilities.” 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  - Subjects with first diagnosis of stroke by a neurologist and confirmed by CT scan
or MRI.
- Subjects with age > 21 years.
- Both male and female subjects.
- Intact touch, pain and temperature sensations.
- Paresis but no paralysis on the hand and arm item of Scandinavian Stroke Scale (SSS).
- Ability to sit on the bed unsupported.
- Ability to follow commands. (MMSE score ≥ 24)
- Cleared for commencing rehabilitation.
- Ability to provide informed consent 
 
ExclusionCriteria 
Details  - Subjects with residual deficits from previous stroke or CNS lesion.
- Subjects with any cognitive impairment, receptive aphasia or visual difficulties.
- Subjects with neuromuscular and orthopedic disorders.
- Other significant upper limb impairment (pain, frozen shoulder, severe arthritis).
- MMSE < 24. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Motor Evaluation Scale for Upper Extremity in Stroke Subjects (MESUPES)  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Fugl-Meyer Assessment of Sensorimotor Function-Upper Extremity (FMA-UE)  2 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/12/2020 
Date of Study Completion (India) 07/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/02/2021 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The importance of early mobilization after stroke cannot be overemphasized. It is well-established that early and graded mobilization lead to faster recovery and better outcomes. Upper limb function is the most important predictor of independence and almost 70% of stroke patients have some degree of impairment of upper limb. Studies have evaluated task oriented training (TOT) for improvement of upper limb functions in stroke subjects in the subacute and chronic phases. However, there are very few studies where early training of upper limb has been carried out, that too with task-oriented approach of intervention. Hence, this study aims to quantify the gains in upper limb function after upper limb task-oriented training in the acute phase of stroke. Treatment will be delivered soon after 48 hours of the event and outcomes will be assessed at the end of 2 weeks using the MESUPES. 
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