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CTRI Number  CTRI/2023/06/054543 [Registered on: 28/06/2023] Trial Registered Prospectively
Last Modified On: 09/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of two therapies on the improvement of hand functions in stroke patients. 
Scientific Title of Study   Comparative efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia: a randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranu Mukherjee 
Designation  Post Graduate Resident  
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room no. 120 , Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), B T Road, Bonhooghly, Kolkata -700090

Kolkata
WEST BENGAL
700090
India 
Phone  7908480207  
Fax    
Email  phulmukherjee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sourov Saha 
Designation  Senior physiotherapist cum junior lecturer 
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room no. 124 , Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), B T Road, Bonhooghly, Kolkata - 700090

Kolkata
WEST BENGAL
700090
India 
Phone  9433845886  
Fax    
Email  sourov.saha.pht@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sourov Saha 
Designation  Senior physiotherapist cum junior lecturer 
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room no. 124 , Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), B T Road, Bonhooghly, Kolkata - 700090

Kolkata
WEST BENGAL
700090
India 
Phone  9433845886  
Fax    
Email  sourov.saha.pht@gmail.com  
 
Source of Monetary or Material Support  
National Institute for Locomotor Disabilities (Divyangjan) 
 
Primary Sponsor  
Name  Ranu Mukherjee 
Address  Flat 4c, Block 1, Katyayani apartment, 31 Italgacha road, Near airport gate no. 1, Kolkata - 700079 
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 Sourov Saha  National Institute for Locomotor Disabilities (Divyangjan)  Room no. 124, Department of Physiotherapy, B T Road, Bonhooghly, Kolkata - 700090
Kolkata
WEST BENGAL 
9433845886

sourov.saha.pht@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of National Institute for Locomotor Disabilities (Divyangjan)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EMG Biofeedback Therapy   EMG Biofeedback Therapy with task oriented training, Standardized exercise program and home care advice for 4 weeks.  
Comparator Agent  Modified Constraint Induced Movement Therapy  Modified Constraint Induced Movement Therapy with task oriented training, Standardized exercise program and home care advice for 4 weeks.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Both male and female patients aged between 45-65 years.
2. The first attack of stroke diagnosed by Physician.
3. Three months to three years post stroke cases.
4. Patient with no cognitive deficit (Mini Mental State Examination score 24 or higher).
5. Brunnstrom hand recovery stage 4 and 5.
6. Patient should have the initiation of active wrist extension.
7. Spasticity grade up to 2 on Modified Ashworth Scale in upper extremity. 
 
ExclusionCriteria 
Details  1. Severe pain in the affected arm (Numeric Pain Rating Scale score above 6).
2. Shoulder subluxation grade more than 2.
3. Patients diagnosed with aphasia, auditory and visual defect.
4. Diagnosed Neurological disorder like Parkinson’s Disease, CRPS, Peripheral
Neuropathies etc. affecting upper extremity.
5. Musculoskeletal conditions like fracture, contracture or deformities affecting upper
extremity.
6. Any sensory impairment in the involved upper extremity.
7. Patients with hemineglect. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Active Range of Motion of wrist extension measured by Universal Goniometer.
2.Maximum Voluntary Isometric Contraction (MVIC) value of wrist extensor
measured by EMG.
3.Functional Performance measured by Fugl-Meyer Assessment Scale. 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   10/07/2023 
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)
Modification(s)  
Open to Recruitment 
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
Modification(s)  

PURPOSE OF THE STUDY :


There are various studies available which have found that the EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy are effective individually in improving the functional performance of hand in patients with hemiplegia. However, to the best of our knowledge there are no studies which have compared the efficacy of EMG Biofeedback Therapy and Modified  Constraint Induced Movement Therapy on hand functions in patients with hemiplegia. Therefore, the purpose of this study is to compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia


AIM:


The aim of this study is to compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.


OBJECTIVES:


1. To find out the efficacy of EMG Biofeedback Therapy on hand functions in patients with hemiplegia.


2. To find out the efficacy of Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.


3. To compare the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia



HYPOTHESIS:


NULL HYPOTHESIS (H0) -

There is no statistically significant difference between the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.


ALTERNATIVE HYPOTHESIS (H1) -

There is statistically significant difference between the efficacy of EMG Biofeedback Therapy and Modified Constraint Induced Movement Therapy on hand functions in patients with hemiplegia.


PROCEDURE:


Approval from the Institutional Ethical Committee (IEC) will be taken before the commencement of the study. All patients diagnosed with hemiplegia after stroke, referred to the Department of Physiotherapy from the Assessment Clinic of the National Institute for Locomotor Disabilities (Divyangjan) will be approached with the proposal of the study. A minimum of 30 patients with hemiplegia after stroke will be assessed and selected according to the inclusion and exclusion criteria. Those fulfilling the inclusion criteria will be informed and explained in detail about the study in their preferable and most communicable language. Informed consent written in their preferred language will be obtained from the patients who are willing to participate. Then the patients will be randomly divided into two groups with a minimum of 15 patients in each group using block randomization method by computer generated random block. The demographic data and outcome measure data will be collected from each patient for Active Range of Motion of the wrist extension by Universal Goniometer, Maximum Voluntary Isometric Contraction value of wrist extensor measured by EMG and Functional Performance using Fugl-Meyer Assessment Scale will be taken at baseline and the end of 16 sessions of intervention. In ‘Group-A’ (n≥15) EMG Biofeedback Therapy with Task Oriented Training and Standardized Exercise Program will be given for 16 sessions (4 sessions

per week for 4 weeks) and in ‘Group-B’ (n≥15) Modified Constraint Induced Movement Therapy with Task Oriented Training and Standardized Exercise Program will be provided for 16 sessions (4 sessions per week for 4 weeks). All the patients of both groups will be given Home Care Advice. Post-intervention data will be collected after 16 sessions from both the groups. Rescue medicines prescribed by the Physician will be continued in both the groups along with a physiotherapeutic approach.


 
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