Concomitant Application of TENS and NMES on Chronic Stroke (TENS NMES)

The Effects of Concomitant Application of TENS and NMES on Chronic Stroke Patients: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation; Device: Neuromuscular and Muscular Electrical Stimulation; Other: Exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34450
    • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS+NMES Group; The group in which TENS and NMES are applied concomitantly in the treatment	Device: 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.; 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.; Other: Exercise program; Specific exercise program for patients with lower extremity hemiparesis after stroke
Active Comparator: TENS Group; The group in which TENS is applied concomitantly in the treatment	Device: 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.; Other: Exercise program; Specific exercise program for patients with lower extremity hemiparesis after stroke
Active Comparator: NMES Group; The group in which NMES is applied concomitantly in the treatment	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.; Other: Exercise program; Specific exercise program for patients with lower extremity hemiparesis after stroke
Sham Comparator: Control; No additional electrical stimulation is applied for treatment in this group.	Other: Exercise program; Specific exercise program for patients with lower extremity hemiparesis after stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale	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.	up to 4 months
Brunnstrom's Hemiplegia Recovery Staging	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.	up to 4 months
Postural Assessment Scale for Stroke Patients	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.	up to 4 months
Functional Independence Measures	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.	up to 4 months
Modified Ashworth Scale	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.	up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical stimulation side effects	Skin lesions, muscle cramps or ruptures, and neurovascular side effects that may occur with the combined application of TENS and NMES will be evaluated.	up to 4 months

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: TENS; Stroke; Exercise program; NMES
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: University of Health Sciences

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes