Concomitant Application of TENS and NMES on Chronic Stroke

NCT06619262 | Terminated FDA Device

• 1 other identifier: University of Health Sciences
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis; Stroke

Keywords

Stroke; Exercise program; TENS; NMES

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Electrical stimulation side effects

  up to 4 months

Study Arms (4)

TENS+NMES Group

EXPERIMENTAL

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

Device: Transcutaneous Electrical Nerve Stimulation; Device: Neuromuscular and Muscular Electrical Stimulation; Other: Exercise program

TENS Group

ACTIVE COMPARATOR

The group in which TENS is applied concomitantly in the treatment

Device: Transcutaneous Electrical Nerve Stimulation; Other: Exercise program

NMES Group

ACTIVE COMPARATOR

The group in which NMES is applied concomitantly in the treatment

Device: Neuromuscular and Muscular Electrical Stimulation; Other: Exercise program

Control

SHAM COMPARATOR

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

Other: Exercise program

Interventions

Transcutaneous Electrical Nerve Stimulation 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.

TENS Group; TENS+NMES Group

Neuromuscular and Muscular Electrical Stimulation 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.

NMES Group; TENS+NMES Group

Exercise program OTHER

Specific exercise program for patients with lower extremity hemiparesis after stroke

Control; NMES Group; TENS Group; TENS+NMES Group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

University of Health Sciences

Istanbul, 34450, Turkey (Türkiye)

Location

Related Publications (1)

• Basar B, Alp OF. The effects of concomitant application of TENS and NMES on chronic stroke patients: a prospective randomized controlled study. BMC Sports Sci Med Rehabil. 2025 Apr 24;17(1):91. doi: 10.1186/s13102-025-01155-w.

  PMID: 40275398 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcutaneous Electric Nerve Stimulation; Resistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective randomized assessor-blind comparison study.

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TU (1)