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
|
|
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
|
|
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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