Clinical trial NCT05953272: A Clinical Trial to Study the Effects of Bobath Therapy With and Without EMG Biofeedback Therapy in Stroke Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
CVA
Bobath therapy
EMG Biofeedback therapy
Lead sponsor: National Institute for Locomotor Disabilities (Divyangjan), India
Sponsor class: OTHER_GOV
First posted: 2023-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, parallel group, active controlled trial.
Primary purpose: TREATMENT

Brief summary: Stroke is a leading cause of disability worldwide. It has a negative impact on the cognitive and sensorimotor functions. Motor recovery becomes essential in rehabilitation phase to make the patient independent in activities of daily living along with improved lower extremity function, balance and gait. Studies show that both EMG Biofeedback therapy and Bobath therapy is effective in improving lower extremity function. Out of those studies, to the best of the investigators knowledge, no study has been conducted to find out the efficacy of EMG Biofeedback therapy along with Bobath therapy on lower extremity functions, balance and gait in 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.

Detailed description: 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 the investigators 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 and Objectives:

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.

Study Variables:

Independent Variables:

1. EMG Biofeedback therapy
2. Bobath therapy

Dependent Variables:

1. Lower extremity function will be measured by - Lower Extremity Subscale of Fugl Meyer Assessment \[FMA\].
2. Balance will be measured by -Timed Up and Go \[TUG\] Test.
3. Gait will be measured by - 10-meter Walk Test \[10mWT\].

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 NILD 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. 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.

Eligibility criteria: Inclusion Criteria:

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 Brunnstrom 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.

Exclusion Criteria:

1. Patient with any sensory deficit of the lower extremity.
2. Problems with vision, like - homonymous hemianopsia, hemiagnosia, 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.

Primary outcomes:
measure: Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks
timeFrame: Baseline, Week 4
measure: Change from Baseline Timed Up and Go Test [TUG] at 4 weeks
timeFrame: Baseline, Week 4
measure: Change from Baseline 10-meter Walk Test [10mWT] at 4 weeks
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Kolkata
country: India
facility: National Institute for Locomotor Disabilities (Divyangjan)
state: West Bengal
Study officials:
affiliation: The West Bengal University of Health Sciences
name: Sanlap Kundu, BPT
role: PRINCIPAL_INVESTIGATOR
References: