A Clinical Trial to Study the Effects of Bobath Therapy With and Without EMG Biofeedback Therapy in Stroke Patients

NCT05953272 | Completed

• 2 other identifiers: IEC/1610/R&D/08/NIOH/20328CTRI/2023/04/051999
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; CVA; Bobath therapy; EMG Biofeedback therapy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks

  Lower extremity function and motor recovery will be measured by the Lower Extremity Subscale of Fugl Meyer Assessment \[FMA\]. It is a simple, reliable and valid scale. It has 2 parts - E. Lower Extremity and F. Co-ordination Speed. Scoring of both the parts combined will determine the motor function of lower limb. In (E) Lower Extremity, it has 5 sub-parts: Reflex activity, Volitional movement within synergies, Volitional movement mixing synergies, Volitional movement with little or no synergy and Normal Reflex activity which has a maximum score of 4, 14, 4, 4, 2; i.e., a maximum total score of 28. The (F) Coordination and Speed has 3 parts to check - Tremor, Dysmetria and Time which has a maximum score of 2, 2 and 2; i.e., maximum total score of 6. The Total Maximum Score for measuring Lower Extremity Motor Function is 34. Patient will be demonstrated about the scale beforehand.

  Baseline, Week 4

• Change from Baseline Timed Up and Go Test [TUG] at 4 weeks

  TUG Test is a reliable and valid scale which is used to assess balance and mobility. In this test, the patient will stand up from a standard arm chair with his/her regular footwear, walk to the line 3 meters away from him on the floor at his/her normal pace and he/she turns, walk back to the chair again at normal pace to sit down again. The patient can use a walking aid, if needed. The therapist will use a stopwatch to measure the time needed by the patient to do all the activity. Patient will be demonstrated about the scale beforehand.

  Baseline, Week 4

• Change from Baseline 10-meter Walk Test [10mWT] at 4 weeks

  In, 10-Meter Walk Test, an individual walks for 14 meters and time will be measured for the intermediate 10 meters to allow for acceleration and deceleration respectively. The therapist will start the timing when the toes of leading foot cross the 2-meter mark and stops timing when the toes of the leading foot cross the 12-meter mark. This test will be performed at Comfortable Gait Speed \[CGS\] and also the Fast Gait Speed \[FGS\] possible. There will be three trials for each speed with a 30 seconds break in between. The mean of the 3 readings will be taken as final outcome. Both of the speeds will be documented in the form. It is a reliable and valid scale. Patient will be demonstrated about the scale beforehand.

  Baseline, Week 4

Study Arms (2)

EMG Biofeedback therapy and Bobath therapy

EXPERIMENTAL

The experimental 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.

Other: EMG Biofeedback therapy and Bobath therapy

Bobath therapy only

ACTIVE COMPARATOR

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.

Other: Bobath therapy

Interventions

EMG Biofeedback therapy and Bobath therapy OTHER

EMG Biofeedback therapy will be used to up-train the ankle dorsiflexors in stroke patients. It will be given for 15 minutes. Patient will practice 2 blocks of Tibialis Anterior muscle contraction trials (holding for 10 seconds per trial with 10 seconds of rest, 20 trials per block with 1 minute 40 seconds of rest in between the blocks) with the heel contacts the floor for a total of 40 trials. In Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session. Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period.

EMG Biofeedback therapy and Bobath therapy

Bobath therapy OTHER

In Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session. Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period.

Bobath therapy only

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient has no cognitive impairment and has a MMSE Score ≥ 24.
• Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
• Patient is in Brunnstrom lower limb recovery stage 3 and 4.
• Patient should have passive 10° or greater ankle dorsiflexion.
• Patient can sit independently on a plinth.
• Patient should be ambulatory either independently or with some assistive aid.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute for Locomotor Disabilities (Divyangjan), India: lead

Study Sites (1)

National Institute for Locomotor Disabilities (Divyangjan)

Kolkata, West Bengal, 700090, India

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sanlap Kundu, BPT

  The West Bengal University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blinded study where the participant is unaware of the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, parallel group, active controlled trial.

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 20, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)