Trials / Terminated

TerminatedNCT06619262

Concomitant Application of TENS and NMES on Chronic Stroke

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

Status: Terminated
Phase: N/A
Study type: Interventional
Enrollment: 60 (actual)

Sponsor: Gaziosmanpasa Research and Education Hospital · Other Government
Sex: All
Age: 35 Years – 85 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2022-11-01
Primary completion: 2023-12-31
Completion: 2024-01-31
First posted: 2024-10-01
Last updated: 2024-10-01

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06619262. Inclusion in this directory is not an endorsement.