| CTRI Number |
CTRI/2023/04/051999 [Registered on: 26/04/2023] 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 |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Bobath therapy with and without EMG Biofeedback therapy in stroke patients |
|
Scientific Title of Study
|
Comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke: a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanlap Kundu |
| Designation |
Post Graduate Student |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy
National Institute for Locomotor Disabilities (Divyangjan)
BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9123065908 |
| Fax |
|
| Email |
misanlapkundu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy
National Institute for Locomotor Disabilities (Divyangjan)
BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9815365870 |
| Fax |
|
| Email |
drpravinkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanlap Kundu |
| Designation |
Post Graduate Student |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Room Number 117, Department of Physiotherapy
National Institute for Locomotor Disabilities (Divyangjan)
BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9123065908 |
| Fax |
|
| Email |
misanlapkundu@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE FOR LOCOMOTOR DISABILITIES (DIVYANGJAN) |
|
|
Primary Sponsor
|
| Name |
SANLAP KUNDU |
| Address |
NATIONAL INSTITUTE FOR LOCOMOTOR DISABILITIES (DIVYANGJAN)
BT ROAD, BONHOOGHLY, KOLKATA
WEST BENGAL
PIN CODE - 700090 |
| 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 |
| Sanlap Kundu |
National Institute for Locomotor Disabilities (Divyangjan) |
Room Number 117,
Department of Physiotherapy
BT Road, Bonhooghly, Kolkata
West Bengal
Pin Code - 700090
North Twentyfour Parganas
WEST BENGAL |
9123065908
misanlapkundu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bobath therapy |
This group will receive only Bobath therapy for 45 minutes and home exercise program. The Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. |
| Intervention |
EMG Biofeedback therapy,
Bobath therapy |
The intervention group will receive EMG Biofeedback therapy for 15 minutes along with Bobath therapy for 45 minutes and home exercise program. The EMG Biofeedback therapy and Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients aged between 40 – 65 years.
2. Patients with first attack of stroke, diagnosed by a physician.
3. Duration of stroke 3 months to 3 years.
4. Patient has no cognitive impairment and has a MMSE Score ≥ 24.
5. Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
6. Patient is in Brunnstorm lower limb recovery stage 3 and 4.
7. Patient should have passive 10° or greater ankle dorsiflexion.
8. Patient can sit independently on a plinth.
9. Patient should be ambulatory either independently or with some assistive aid. |
|
| ExclusionCriteria |
| Details |
1. Patient with any sensory deficit of the lower extremity.
2. Problems with vision, like – homonymous hemianopsia, hemi agnosia, visual agnosia etc.
3. Patients with hearing loss.
4. Patients with hemineglect.
5. Patients with sensory, conduction or global aphasia.
6. Musculoskeletal conditions like – fracture, contracture and deformity in lower extremity.
7. Diagnosed neurological diseases like – Parkinsonism, Dementia, Peripheral nerve injury in the lower extremity etc.
8. Diagnosed systemic diseases like – uncontrolled hypertension etc. and/or peripheral vascular disease in lower extremity like – Raynaud’s disease etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Lower extremity function by – Lower Extremity Subscale of Fugl Meyer Assessment [FMA].
2. Balance by –Timed Up and Go [TUG] Test.
3. Gait by – 10-meter Walk Test [10mWT]. |
2 times – on day 0 and after 4 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
|
PURPOSE
OF THE STUDY:
THERE
ARE STUDIES AVAILABLE IN WHICH EMG BIOFEEDBACK THERAPY SIGNIFICANTLY IMPROVES
LOWER EXTREMITY FUNCTIONS. BOBATH THERAPY HAS ALSO SHOWN SIGNIFICANT EFFECT
IN RECOVERY OF LOWER EXTREMITY FUNCTIONS AFTER STROKE. OUT OF THOSE STUDIES,
TO THE BEST OF OUR KNOWLEDGE, NO STUDY HAS BEEN CONDUCTED TO FIND THE
COMPARATIVE EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG WITH BOBATH THERAPY AND
BOBATH THERAPY ALONE ON LOWER EXTREMITY FUNCTIONS, BALANCE AND GAIT IN INDIAN
POPULATION WITH STROKE PATIENTS.
THEREFORE,
THE PURPOSE OF THE STUDY IS TO FIND OUT THE COMPARATIVE EFFICACY OF EMG
BIOFEEDBACK THERAPY ALONG WITH BOBATH THERAPY AND BOBATH THERAPY ALONE ON
LOWER EXTREMITY FUNCTIONS, BALANCE AND GAIT IN PATIENTS WITH STROKE.
AIM:
TO
FIND OUT THE COMPARATIVE EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG WITH
BOBATH THERAPY AND BOBATH THERAPY ALONE ON LOWER EXTREMITY FUNCTIONS, BALANCE
AND GAIT IN PATIENTS WITH STROKE.
OBJECTIVES:
1. TO
FIND OUT THE EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG WITH BOBATH THERAPY ON
LOWER EXTREMITY FUNCTIONS, BALANCE AND GAIT IN PATIENTS WITH STROKE.
2. TO
FIND OUT THE EFFICACY OF BOBATH THERAPY ON LOWER EXTREMITY FUNCTIONS, BALANCE
AND GAIT IN PATIENTS WITH STROKE.
3.
TO COMPARE THE EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG WITH BOBATH THERAPY
AND BOBATH THERAPY ALONE ON LOWER EXTREMITY FUNCTIONS, BALANCE AND GAIT IN
PATIENTS WITH STROKE.
HYPOTHESES:
NULL
HYPOTHESIS: THERE IS NO STATISTICALLY
SIGNIFICANT DIFFERENCE BETWEEN THE EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG
WITH BOBATH THERAPY AND BOBATH THERAPY ALONE ON LOWER EXTREMITY FUNCTIONS,
BALANCE AND GAIT IN PATIENTS WITH STROKE.
ALTERNATIVE
HYPOTHESIS: THERE IS STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE
EFFICACY OF EMG BIOFEEDBACK THERAPY ALONG WITH BOBATH THERAPY AND BOBATH
THERAPY ALONE ON LOWER EXTREMITY FUNCTIONS, BALANCE AND GAIT IN PATIENTS WITH
STROKE.
PROCEDURE:
APPROVAL
FROM THE INSTITUTIONAL ETHICAL COMMITTEE (IEC) WILL BE TAKEN BEFORE
COMMENCEMENT OF THE STUDY. ALL PATIENTS DIAGNOSED WITH HEMIPLEGIC STROKE
REFERRED FROM ASSESSMENT CLINIC OF NATIONAL INSTITUTE FOR LOCOMOTOR DISABILITIES
(DIVYANGJAN) TO THE DEPARTMENT OF PHYSIOTHERAPY WILL BE APPROACHED WITH THE
STUDY PROPOSAL. MINIMUM OF 30 PATIENTS WITH HEMIPLEGIC STROKE WILL BE
INCLUDED AFTER PROPER ASSESSMENT AND SCREENING ACCORDING TO THE INCLUSION AND
EXCLUSION CRITERIA. THOSE FULFILLING THE INCLUSION CRITERIA WILL BE EXPLAINED
IN DETAILS ABOUT THE STUDY IN THEIR MOST COMMUNICABLE LANGUAGE. WRITTEN
INFORMED CONSENT IN THEIR PREFERRED LANGUAGE WILL BE OBTAINED FROM THE
PATIENTS AGREEING TO PARTICIPATE. THE PATIENTS WILL BE RANDOMLY DIVIDED INTO TWO
GROUPS USING BLOCK RANDOMIZATION METHOD BY COMPUTER GENERATED RANDOM
BLOCKS.[32] THE DEMOGRAPHIC DATA AND THE OUTCOME MEASURES DATA WILL BE
COLLECTED FROM EACH PATIENT FOR LOWER EXTREMITY FUNCTION BY LOWER EXTREMITY
SUBSCALE OF FUGL MEYER ASSESSMENT [FMA], BALANCE BY TIMED UP AND GO TEST
[TUG] AND GAIT BY 10-METER WALK TEST [10MWT] AT BASELINE AND AT THE END OF
FOUR WEEKS OF INTERVENTION. IN GROUP-A (N≥15) EMG BIOFEEDBACK THERAPY AND
BOBATH THERAPY WILL BE GIVEN FOR 16 SESSIONS (4 SESSIONS PER WEEK FOR 4 WEEKS).
IN GROUP- B (N≥15) ONLY BOBATH THERAPY WILL BE GIVEN FOR 16 SESSIONS (4
SESSIONS PER WEEK FOR 4 WEEKS). HOME EXERCISE PROGRAM WILL BE GIVEN IN BOTH
GROUPS.
RESCUE MEDICATIONS DULY PRESCRIBED BY PHYSICIAN WILL BE CONTINUED ALONG WITH THE PHYSIOTHERAPEUTIC APPROACH IN BOTH THE GROUPS DURING THE STUDY. | |