| CTRI Number |
CTRI/2025/03/083699 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the improvement in balance and walking using EMG Biofeedback with and without Optokinetic Stimulation in patients with stroke |
|
Scientific Title of Study
|
Effectiveness of Electromyography (EMG) Biofeedback With and Without Optokinetic Stimulation on Balance and Gait in Stroke Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avani Nataraj K |
| Designation |
PG Student |
| Affiliation |
R.V. College of Physiotherapy |
| Address |
G02
Department of Neurological Physiotherapy
RV College of Physiotherapy
No.CA 2 83-3 9th Main Rd 4th T Block East 4th Block Jayanagar
Bangalore
KARNATAKA
560011
India |
| Phone |
8971501802 |
| Fax |
|
| Email |
avani.nataraj99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trapthi Kamath |
| Designation |
Associate Professor |
| Affiliation |
R.V. College of Physiotherapy |
| Address |
G02
Department of Neurological Physiotherapy
RV College of Physiotherapy
No.CA 2 83-3 9th Main Rd 4th T Block East 4th Block Jayanagar
Bangalore
KARNATAKA
560011
India |
| Phone |
|
| Fax |
|
| Email |
trapthikamath.rvcp@rvei.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Avani Nataraj K |
| Designation |
PG Student |
| Affiliation |
R.V. College of Physiotherapy |
| Address |
G02
Department of Neurological Physiotherapy
RV College of Physiotherapy
No.CA 2 83-3 9th Main Rd 4th T Block East 4th Block Jayanagar
KARNATAKA
560011
India |
| Phone |
8971501802 |
| Fax |
|
| Email |
avani.nataraj99@gmail.com |
|
|
Source of Monetary or Material Support
|
| G02
Department of Neurological Physiotherapy
RV College of Physiotherapy
No.CA 2 83-3 9th Main Rd 4th T Block East 4th Block Jayanagar
Bengaluru Karnataka 560011 |
|
|
Primary Sponsor
|
| Name |
Avani Nataraj K |
| Address |
#186 2nd A Cross KPSC Layout Nagadevanahalli Bengaluru 560056 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Avani Nataraj K |
RV College of Physiotherapy |
G02 Department of Neurological Physiotherapy RV College of Physiotherapy No.CA 2 83-3 9th Main Rd 4th T Block East 4th Block Jayanagar
Bangalore
KARNATAKA |
8971501802
avani.nataraj99@gmail.com |
| Avani Nataraj K |
Sukino Hospital |
Department of Rehabilitation
5th floor
196 Circle
Bannerghatta Rd Arekere
Bengaluru Karnataka 560076
Bangalore
KARNATAKA |
8971501802
avani.nataraj99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| RV INSTITUTIONAL ETHICAL COMMITTE |
Approved |
| RV INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electromyography (EMG) biofeedback with Optokinetic Stimulation |
Optokinetic stimulation will be given on an electronic device with a velocity of 1cm/s for a duration of 20 minuites (4 minuites with 1 min rest) along with which EMG biofeedback will be given for ankle strengthening for a 20 minuite duration. Both therapies will be given for 2 days weekly for 8 weeks. |
| Comparator Agent |
Electromyography (EMG) biofeedback without Optokinetic Stimulation |
EMG biofeedback will be given for ankle strengthening for a 20 minuite duration. It will be given for 2 days weekly for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate as volunteers and sign the informed written consent.
Subjects diagnosed with one time stroke.
Able to maintain upright standing posture
Subjects who are medically stable
Subjects with MoCA score more than 26
Subjects with FAC score more than than 3 |
|
| ExclusionCriteria |
| Details |
Any other neurological or rheumatic disorders
Recent spinal or lower limb surgery
Any spinal or limb deformities
Uncontrolled hypertension
Skin rashes or allergy
Lower extremity fractures
Amputation of lower extremity
Vestibular disorders
Partial or Complete Blindness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVE BALANCE AND GAIT WITH THE TINETII PERFORMANCE ORIENTED MOBILITY ASSESSMENT SCALE |
2
PRE-INTERVENTION
POST-INTERVENTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVE FALL RISK |
2
PRE-INTERVENTION
POST-INTERVENTION |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title
EFFECTIVENESS OF ELECTROMYOGRAPHY (EMG) BIOFEEDBACK WITH AND WITHOUT OPTOKINETIC STIMULATION ON BALANCE AND GAIT IN STROKE PATIENTS- A COMPARATIVE STUDY
Introduction
Stroke is one of the leading causes of disability worldwide, affecting millions of people each year. Many stroke survivors struggle with balance and walking, making everyday activities challenging and increasing their risk of falls. Traditional rehabilitation methods focus on improving motor control, but newer approaches, like Electromyographic (EMG) Biofeedback and Optokinetic Stimulation (OKS), have shown to be effective in various literature. EMG Biofeedback provides real-time feedback on muscle activity, helping patients regain control, while OKS stimulates the brain using visual motion cues to stimulate and strengthen the vestibulo-ocular reflex to improve stability. This study explores whether combining these two therapies leads to better recovery compared to using EMG Biofeedback alone. Aim and Objectives
Aim: To compare the effectiveness of EMG Biofeedback with and without Optokinetic Stimulation in improving balance and gait in individuals with stroke.
Objectives: To assess the effectiveness of Optokinetic Stimulation combined with EMG Biofeedback on balance improvement in stroke survivors. To evaluate the impact of Optokinetic Stimulation with EMG Biofeedback on gait in stroke patients. To determine the effectiveness of EMG Biofeedback alone in enhancing balance. To analyze the effectiveness of EMG Biofeedback alone in improving gait.
Methodology and Procedure
A non-randomized comparative parallel-arm study will be conducted on 60 stroke patients divided into two groups:
Group A: EMG Biofeedback with Optokinetic Stimulation
Group B: EMG Biofeedback without Optokinetic Stimulation
Participants will undergo an 8-week intervention, with balance and gait assessed using the Tinetti Performance-Oriented Mobility Assessment (POMA) scale. Conventional therapy, including stretching, strengthening, and balance training, will be provided to both groups. The study will be conducted at R.V. College of Physiotherapy and affiliated centers.
Statistical Analysis
Descriptive statistics will summarize categorical variables as frequencies and percentages, and quantitative variables as means and standard deviations. The effectiveness of interventions will be analyzed using paired t-tests or Wilcoxon signed-rank tests for within-group comparisons, and unpaired t-tests or Mann-Whitney U tests for between-group comparisons. A p-value of less than 0.05 will be considered statistically significant.
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