Concomitant Application of TENS and NMES on Chronic Stroke
- Conditions
- StrokeHemiparesis
- Interventions
- Device: Transcutaneous Electrical Nerve StimulationDevice: Neuromuscular and Muscular Electrical StimulationOther: Exercise program
- Registration Number
- NCT06619262
- Lead Sponsor
- Gaziosmanpasa Research and Education Hospital
- Brief Summary
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. Studies conducted with electrical stimulation have shown that it is safe to use on humans. Today, it is frequently preferred in treatment.
Electrical stimulation are effective for treatment of stroke. Electrical stimulation has been used as transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). Both of them are effective but not sufficient. The concomitant application of TENS and NMES may achieve better results than individually application.
- Detailed Description
Stroke is a cerebrovascular disorder that can lead to permanent disability and a decline in quality of life. Chronic stroke patients often experience decreased balance control, which negatively affects activities of daily living and their ability to walk independently. The most recognized impairments are deficits in motor control and limited mobility. Chronic stroke patients may develop spasticity, which is the main cause of decreased balance and gait. The rate of post-stroke spasticity is 4 - 27% in the 6th week, increasing to 42.6% by the 6th month. Electrical stimulation has been used in numerous studies to decrease spasticity.
Electrical stimulation has been widely used in stroke rehabilitation, including transcutaneous nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). NMES is an effective and conventional therapeutic method for improving motor function in patients with lower extremity paralysis after stroke. During NMES, current pulses are applied to the muscles or motor nerves through surface electrodes to induce muscle contractions to mimic exercise therapy. NMES can help improve muscle strength, joint range of motion, and promote motor relearning. TENS, another electrical stimulation, is used to relieve pain, improve muscle strength and motor function, and reduce spasticity through transdermal output pulses. The motor recovery mechanism of TENS involves the presynaptic inhibition of the hyperactive stretch reflexes in spastic muscles and decreased co-contraction of the spastic antagonist muscles.
Numerous studies have investigated the benefits of TENS or NMES applied to the lower extremities. These studies have revealed that both forms of electric stimulation are effective in the recovery of chronic stroke patients.
However, there is no comparative study on the effect of TENS and NMES applied individually versus their concomitant application. The combined application of TENS and NMES may yield better results. The aim of this study is to compare the effects of TENS and NMES, applied both individually and concomitantly, on posture, lower extremity motor recovery, functional independence, motor function recovery, and spasticity. Hypothesis is that the concomitant application of TENS and NMES will achieve better results than individually application.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
First episode of unilateral stroke with hemiparesis Stroke confirmed by CT and/or MRI Ablity to independently stand up from a chair
Cerebellar or brainstem stroke Severe cognitive and communication impairment Previous surgical treatment history on the affected extremity Complication with severe heart, lung, liver, kidney, or infectious disease Presence of a cardiac pacemaker Orthopedic disease affecting sit-to-stand movement Inability to understand and follow verbal commands Peripheral or central nervous system dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TENS+NMES Group Transcutaneous Electrical Nerve Stimulation The group in which TENS and NMES are applied concomitantly in the treatment TENS+NMES Group Neuromuscular and Muscular Electrical Stimulation The group in which TENS and NMES are applied concomitantly in the treatment TENS+NMES Group Exercise program The group in which TENS and NMES are applied concomitantly in the treatment TENS Group Transcutaneous Electrical Nerve Stimulation The group in which TENS is applied concomitantly in the treatment TENS Group Exercise program The group in which TENS is applied concomitantly in the treatment NMES Group Neuromuscular and Muscular Electrical Stimulation The group in which NMES is applied concomitantly in the treatment NMES Group Exercise program The group in which NMES is applied concomitantly in the treatment Control Exercise program No additional electrical stimulation is applied for treatment in this group.
- Primary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale up to 4 months Disability caused by stroke was evaluated using the National Institutes of Health Stroke Scale (NIHSS). The following domains were assessed with the NIHSS: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Evaluation was based on a total score ranging from 0 to 42, with higher the scores indicating more severe stroke.
Brunnstrom's Hemiplegia Recovery Staging up to 4 months The lower extremity motor recovery was assessed using Brunnstrom's Hemiplegia Recovery Staging. There are six grades in Brunnstrom's Hemiplegia Recovery Staging for the lower extremity. A higher stage indicates better motor function. The Brunnstrom stages were preferred because they reflect the underlying motor control based on clinical assessment of movement quality.
Postural Assessment Scale for Stroke Patients up to 4 months Postural Assessment Scale for Stroke Patients (PASS) was developed specifically for evaluating balance in stroke patients. PASS contains two subheadings for evaluating balance: maintaining posture (static PASS) and changing posture (dynamic PASS). It consists of 12 items to evaluate balance: 5 items (sitting without support; standing with support; standing without support; standing on the non-paretic leg; standing on the paretic leg) for static PASS, and 7 items (supine to affected side lateral; supine to non-affected side lateral; supine to sitting up on the edge of the mat; sitting on the edge of the mat to supine; sitting to standing; standing to sitting down; standing, picking up a pencil from the floor) for dynamic PASS. Evaluation was based on a total score ranging from 0 to 36, with higher the scores indicating more favorable balance in stroke patients.
Functional Independence Measures up to 4 months Functional Independence Measures (FIM) is widely used to assess the independence of stroke patients. It contains 18 items under the following categories: self-care, sphincter control, transfers, locomotion, communication and social cognition. Each item was scored from 1 to 7, with 7 indicating complete independence and 1 indicating complete dependence. Scores below 6 indicate that the patient requires assistance or supervision from another person.
Modified Ashworth Scale up to 4 months The Modified Ashworth Scale (MAS) was used to assess the spasticity of the ankle plantar flexors. The physiotherapist passively moved the ankle from maximal plantarflexion to maximal dorsiflexion. The MAS assigns a grade of spasticity on a scale of 0-4 based on the level of resistance in response to passive movement. A score of 0 represents no increase in muscle tone, while a score of 4 represents rigidity of the affected part in flexion or extension.
- Secondary Outcome Measures
Name Time Method Electrical stimulation side effects up to 4 months Skin lesions, muscle cramps or ruptures, and neurovascular side effects that may occur with the combined application of TENS and NMES will be evaluated.
Trial Locations
- Locations (1)
University of Health Sciences
🇹🇷İstanbul, Turkey