Clinical trial NCT03811106: Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals
Official title: Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia
Keywords: Electrotherapy, Neuromuscular Electrical Stimulation, Stroke
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled
Primary purpose: TREATMENT

Brief summary: Specific clinical tools and treatment variables have a key role on the results to be obtained. Therefore, there is a need for well-planned studies on the effect of Neuromuscular Electrical Stimulation (NMES) on stroke patients. Although NMES is frequently used in patients with stroke, scientific evidence regarding back extensor muscle stimulation, functional capacity, balance and mobility efficiency in this patient group is not sufficient. This study was planned to compare controlled individuals with neurological rehabilitation. According to the definition of World Health Organization (WHO) stroke; It is a rapidly developing clinical condition due to local or general impairment of brain functions, without apparent cause other than vascular causes. In the world, the loss of disability and labor force is known as the first and the second cause of deaths.

Post-stroke intensive care and rehabilitation processes vary between countries. For example, in Australia, $ 2.14 billion is spent each year for the treatment of stroke-diagnosed individuals, while US $ 65 million is spent annually. For these reasons, it is very important to choose low-cost, effective and evidence-based physiotherapy approaches for people with stroke. Hemiparesis, which is characterized by a loss of power on one side of the body, is the most common neurological loss after stroke. Patients with hemiparetic stroke often have impaired balance, mobility and functional capacity. This results in a high economic burden and social problem in this person. Among the functional problems after stroke; impaired balance, abnormal walking pattern with abnormal asymmetry, abnormal body and spinal movement can be shown. The most important problem is the loss of mobility; bed activities include sitting and standing. The most important goal of stroke rehabilitation is the recovery of mobility and balance. Changes in walking pattern and balance abilities occur due to motor control loss, spasticity, muscle weakness, joint motion deficit, abnormal movement patterns and sensory dysfunction. In addition to neurophysiological treatment techniques such as Bobath, conventional exercise programs, Brunnstrom and proprioceptive neuromuscular parasilication, with the aim of improving the quality of movement and maintaining the balance in rehabilitation of stroke-diagnosed patients, electrical stimulation is also used.Although the importance of back extensor muscle strength is documented in the literature, it is observed that studies focusing on back extensor muscle strength in limb rehabilitation are limited.

Control disorders in the posterior extensor muscles after stroke are found to be significantly associated with balance, gait and upper extremity dysfunctions.

Based on this idea, our study was planned to examine the effect of NMEs application on functional capacity, balance and mobility in stroke individuals.

Detailed description: Our study will be carried out in Fırat University Training and Research Hospital. Individuals who are diagnosed with stroke by the Physical Medicine and Rehabilitation Specialist and who are directed to the physiotherapy program will be included. 20 hemiparesis patients who underwent stimulation and conventional physiotherapy and rehabilitation of the back extensors, will constitute 20 volunteer patients who only provided conventional physiotherapy and rehabilitation applications. 20 cases were included in the study and 20 cases as control group. All cases will be informed and approved before they start working.

Inclusion Criteria

1. Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO)
2. At least 3 months after SVO
3. Mini-mental State Examination (MMSE) value ≥ 15
4. Being in the 30 to 80 age range
5. Back extensor muscle spasticity value \<4 according to modified Ashworth Scale

Criteria for Inclusion of Patients in the Study

1. Ataxia, dystonia, dyskinesia
2. The presence of lower motor neuron or peripheral nerve lesion
3. Degraded deep senses
4. Detection disorder and dementia
5. Skin and peripheral circulatory disorder
6. History of CVO, bilateral hemiplegia

As demographic characteristics; age, gender, body weight, height of the patients, the hand (dominant hemisphere), occupation and educational status, as a history of the disease; It will be noted whether the patient has undergone SVO or transient ischemic attack. Our neurological evaluation form; Reflexes, sensory defects, cranial nerve lesion, visual disturbances, speech problem and type will be recorded.

All patients will be evaluated after treatment (TS). Spasticity will be graded from 0 to 5 according to the Modified Ashworth Scale.

Postural Assesment of Stroke Scale (PASS), Short Form-36, Adapted Patient Evaluation and Conference System, Stroke Rehabilitation Assesment of Movement (STREAM), Brunel Balance Assessment (BBA), Functional Ambulation Scale(FAS) and Mini-Mental State Examination (MMSE) surveys and scales will be used.

Stimulation program, symmetrical biphasic waveform, 50 Hz frequency, 400 μs width flow characteristics are used and the duration of treatment should be 30 min.

The current density will be adjusted to give full contraction of the back extensor muscle at each warning. It will be adjusted separately in each session without any discomfort or pain. In cases where contraction is reduced, the intensity of the current will be increased to achieve the same quality contraction. However, the target muscles outside the muscles will spread to the muscles strong enough to be created.

Statistical analysis of the study will be done with Statistical Package for Social Sciences (SPSS) Version IBM Statistic 20. Mann Whitney U test will be used for the differences between the two groups. Comparisons between the pre-treatment and post-treatment values of the patients will be done by Wilcoxon Signed Rank test in dependent groups.

The obtained values will be expressed as mean ± standard deviation (SD). The differences below p \<0.05 would be considered significant.

Eligibility criteria: Inclusion Criteria:

1. Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO)
2. At least 3 months after SVO
3. Mini-mental State Examination (MMSE) value ≥ 15
4. Being in the 30 to 80 age range
5. Back extensor muscle spasticity value \<4 according to modified Ashworth Scale

Exclusion Criteria:

1. Ataxia, dystonia, dyskinesia
2. The presence of lower motor neuron or peripheral nerve lesion
3. Degraded deep senses
4. Detection disorder and dementia
5. Skin and peripheral circulatory disorder
6. History of CVO, bilateral hemiplegia

Primary outcomes:
measure: Effects on Functional Capacity and Mobility
timeFrame: 8 Months
measure: Brunnel Balance Scale:
timeFrame: 8 Months
measure: Stroke Rehabilitation Assesment of Movement (STREAM)
timeFrame: 8 Months
measure: Functional Ambulation Classification
timeFrame: 8 Months
measure: Adapted Patient Evaluation and Conference System
timeFrame: 8 Months
measure: Postural Assesment of Stroke Scale (PASS)
timeFrame: 8 Months
measure: Short Form-36
timeFrame: 8 Months
measure: Mini Mental State Examination Test
timeFrame: 8 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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