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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a single-blinded study where the participant is unaware of the group allocation.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
- •Patient is in Brunnstrom lower limb recovery stage 3 and
- •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.
排除标准
- •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.
研究组 & 干预措施
EMG Biofeedback therapy and Bobath therapy
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.
干预措施: EMG Biofeedback therapy and Bobath therapy (Other)
Bobath therapy only
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.
干预措施: Bobath therapy (Other)
结局指标
主要结局
Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks
时间窗: Baseline, Week 4
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.
Change from Baseline 10-meter Walk Test [10mWT] at 4 weeks
时间窗: Baseline, Week 4
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.
Change from Baseline Timed Up and Go Test [TUG] at 4 weeks
时间窗: Baseline, Week 4
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.
次要结局
未报告次要终点
研究者
SANLAP KUNDU
Principal Investigator
National Institute for Locomotor Disabilities (Divyangjan), India