A clinical trial to study the effects of Bobath therapy with and without EMG Biofeedback therapy in stroke patients
- Conditions
- Sequelae of unspecified cerebrovascular diseases,
- Registration Number
- CTRI/2023/04/051999
- Lead Sponsor
- SANLAP KUNDU
- Brief Summary
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|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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Both male and female patients aged between 40 – 65 years.
- Patients with first attack of stroke, diagnosed by a physician.
- Duration of stroke 3 months to 3 years.
- Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
- Patient is in Brunnstorm lower limb recovery stage 3 and 4.
- Patient can sit independently on a plinth.
- Patient should be ambulatory either independently or with some assistive aid.
- Patient with any sensory deficit of the lower extremity.
- Problems with vision, like – homonymous hemianopsia, hemi agnosia, visual agnosia etc.
- Patients with hearing loss.
- Patients with hemineglect.
- Patients with sensory, conduction or global aphasia.
- Musculoskeletal conditions like – fracture, contracture and deformity in lower extremity.
- Diagnosed neurological diseases like – Parkinsonism, Dementia, Peripheral nerve injury in the lower extremity etc.
- Diagnosed systemic diseases like – uncontrolled hypertension etc.
- and/or peripheral vascular disease in lower extremity like – Raynaud’s disease etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Lower extremity function by – Lower Extremity Subscale of Fugl Meyer Assessment [FMA]. 2 times – on day 0 and after 4 weeks of intervention. 2. Balance by –Timed Up and Go [TUG] Test. 2 times – on day 0 and after 4 weeks of intervention. 3. Gait by – 10-meter Walk Test [10mWT]. 2 times – on day 0 and after 4 weeks of intervention.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institute for Locomotor Disabilities (Divyangjan)
🇮🇳Parganas, WEST BENGAL, India
National Institute for Locomotor Disabilities (Divyangjan)🇮🇳Parganas, WEST BENGAL, IndiaSanlap KunduPrincipal investigator9123065908misanlapkundu@gmail.com