Concomitant Application of TENS and NMES on Chronic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective randomized assessor-blind comparison study.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TENS+NMES Group

The group in which TENS and NMES are applied concomitantly in the treatment

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

TENS stands for transcutaneous electrical nerve stimulation. Transcutaneous means across the skin. TENS machines pass a small electrical current across your skin to stimulate the nerves.

Neuromuscular and Muscular Electrical Stimulation

Intervention Type DEVICE

Neuromuscular and Muscular Electrical Stimulation (NMES) is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous system.

Exercise program

Intervention Type OTHER

Specific exercise program for patients with lower extremity hemiparesis after stroke

TENS Group

The group in which TENS is applied concomitantly in the treatment

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type DEVICE

TENS stands for transcutaneous electrical nerve stimulation. Transcutaneous means across the skin. TENS machines pass a small electrical current across your skin to stimulate the nerves.

Exercise program

Intervention Type OTHER

Specific exercise program for patients with lower extremity hemiparesis after stroke

NMES Group

The group in which NMES is applied concomitantly in the treatment

Group Type ACTIVE_COMPARATOR

Neuromuscular and Muscular Electrical Stimulation

Intervention Type DEVICE

Neuromuscular and Muscular Electrical Stimulation (NMES) is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous system.

Exercise program

Intervention Type OTHER

Specific exercise program for patients with lower extremity hemiparesis after stroke

Control

No additional electrical stimulation is applied for treatment in this group.

Group Type SHAM_COMPARATOR

Exercise program

Intervention Type OTHER

Specific exercise program for patients with lower extremity hemiparesis after stroke

Interventions

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Transcutaneous Electrical Nerve Stimulation

TENS stands for transcutaneous electrical nerve stimulation. Transcutaneous means across the skin. TENS machines pass a small electrical current across your skin to stimulate the nerves.

Intervention Type DEVICE

Neuromuscular and Muscular Electrical Stimulation

Neuromuscular and Muscular Electrical Stimulation (NMES) is a modality that sends electrical impulses to nerves which causes the muscles to contract mimicking the action potential coming from the central nervous system.

Intervention Type DEVICE

Exercise program

Specific exercise program for patients with lower extremity hemiparesis after stroke

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

First episode of unilateral stroke with hemiparesis Stroke confirmed by CT and/or MRI Ablity to independently stand up from a chair

Exclusion Criteria

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No