Clinical trial NCT06619262: Concomitant Application of TENS and NMES on Chronic Stroke
Official title: The Effects of Concomitant Application of TENS and NMES on Chronic Stroke Patients: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Stroke
Exercise program
TENS
NMES
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized assessor-blind comparison study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: up to 4 months
measure: Brunnstrom's Hemiplegia Recovery Staging
timeFrame: up to 4 months
measure: Postural Assessment Scale for Stroke Patients
timeFrame: up to 4 months
measure: Functional Independence Measures
timeFrame: up to 4 months
measure: Modified Ashworth Scale
timeFrame: up to 4 months
Secondary outcomes:
measure: Electrical stimulation side effects
timeFrame: up to 4 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences
Study officials:
References: