| CTRI Number |
CTRI/2024/05/067905 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of EMG Biofeedback and Task Oriented Training on upper limb stroke patients |
|
Scientific Title of Study
|
Effects Of EMG Biofeedback and Task oriented training On upper extremity motor function in individuals with sub acute 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 |
R Porkodi |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna College of Physiotherapy |
| Address |
Sri Ramakrishna College Of Physiotherapy 4017 Department of physiotherapy Sri Ramakrishna Institute of Paramedical Sciences #395 Sarojini Naidu Road Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rekha |
| Designation |
Associate Professor |
| Affiliation |
Saveetha College Of Physiotherapy |
| Address |
Saveetha College Of Physiotherapy Saveetha Institute Of Medical and Technical Sciences Thandalam Chennai
Chennai
TAMIL NADU
600128
India |
| Phone |
9840545975 |
| Fax |
|
| Email |
rekha.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Rekha |
| Designation |
Associate Professor |
| Affiliation |
Saveetha College Of Physiotherapy |
| Address |
Saveetha College Of Physiotherapy Saveetha Institute Of Medical and Technical Sciences Thandalam Chennai
Chennai
TAMIL NADU
600128
India |
| Phone |
9840545975 |
| Fax |
|
| Email |
rekha.scpt@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Multispeciality Hospital Room No 4017 Division of Neurology Department Of Physiotherapy 395,Sarojini Naidu Road Coimbatore Tamilnadu 641044
|
|
|
Primary Sponsor
|
| Name |
R Porkodi |
| Address |
Sri Ramakrishna College Of Physiotherapy Room No 4017 Department Of Physiotherapy,Sri Ramakrishna Institute of Paramedical Sciences #395 Sarojini Naidu Road Coimbatore Tamilnadu 641044 |
| 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 V S SEETHARAMAN |
Sri Ramakrishna Multispeciality Hospital |
Room No 4017 Department of physiotherapy Sri Ramakrishna Multispeciality Hospital #395 Sarojini Naidu Road
Coimbatore
TAMIL NADU |
9842744406
seeraman_vs@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Multispeciality Hospital Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMG Biofeedback Therapy and Task Oriented Training |
EMG Biofeedback Therapy for 45 Minutes and Task Oriented Training for 45 Minutes
3 Sessions per Week for 12 Weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Ischemic or hemorrhagic type of MCA
stroke
Cognitively able to follow instructions
Single stroke duration of 3 to 12months
Mini mental state examination MMSE score greater than or equal to 27
Modified Ashworth Scale between 2 to 3
Able to sit in a chair for the duration of the session about 1 hour
Voluntary scale grade greater than 4 |
|
| ExclusionCriteria |
| Details |
Patient with subluxation of
glenohumeral joint
Patient with unilateral neglect
Severe psychiatric disorders
Active implantable devices for example pacemaker
or other metal implants within the stimulation area
Severe or frequent epileptic seizures in the past
Other medical comorbidities
Wounds in the application area of the electrodes placement
Hearing and visual deficits |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upper Limb Motor Function at baseline 4th week 8th week and 12thweek |
Upper Limb Motor Function at baseline 4th week 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Effects of EMG Biofeedback and Task oriented training on upper extremity motor function in individuals with sub acute stroke ABSTRACT
BACKGROUNG: Stroke is a leading cause of long-term disability worldwide, often resulting in significant impairments in upper extremity motor function . Subacute stroke rehabilitation plays a crucial role in maximizing functional recovery and improving the quality of life for stroke survivors. Prevalence of Upper Extremity Motor Impairment: Upper extremity motor impairment is a common consequence of stroke. Studies have shown that approximately 77-88% of stroke survivors experience some degree of upper limb motor impairment (Kwakkel et al., 2003; Nakayama et al., 1994). These impairments can range from mild to severe, affecting activities of daily living and overall quality of life.
AIM OF THE STUDY: Various rehabilitation approaches, including EMG biofeedback, task-oriented training, and conventional therapy, have shown promise in facilitating upper extremity motor recovery.
My research aims to investigate and compare the effects of these interventions on upper extremity motor function in individuals with subacute stroke.
NEED OF THE STUDY: Functional Limitations: Upper extremity motor impairment often leads to functional limitations. According to a study by Nichols-Larsen et al. (2005), about 65% of stroke survivors experience difficulty with basic activities such as feeding, dressing, and toileting due to upper extremity motor impairment Effect on Quality of Life: The impact of upper extremity motor impairment on the quality of life is substantial. A study by Granger et al. (1998) demonstrated that upper limb motor impairment negatively affects multiple domains of the quality of life, including physical, psychological, and social aspects. Improved understanding of effective rehabilitation techniques for subacute stroke patients. Potential for improved motor function and ability to perform daily activities for individuals with stroke.
|