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NCT Number: NCT06725069

Effects of Neuromuscular Electrical Stimulation on Flexor Spasticity and Function in Stroke Patients

In this study, the investigators aimed to determine the effects of botulinum neurotoxin type A injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Hemiplegia Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SBÜ Gaziler Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

About this study

Neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type A injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, To determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with ischemic or hemorhagic stroke after imaging with CT/MRI
  • First time stroke survivor
  • between 45-75 years old
  • Stroke duration > 3 months
  • Neurologically stable
  • Affected wrist and finger flexor muscle spasticity with MAS≥2
  • Patients whose cognitive status is at a level to understand the study instructions MMT> 23)

Exclusion criteria

  • Presence of another neurological disorder other than stroke causing motor impairment/spasticity
  • Fixed contracture in the hand-wrist
  • Use of medical treatment for spasticity
  • Having received neurolytic therapy, BoNT-A injection or NMES treatment in the last 3 months
  • Skin problem (disease, allergy, infection, etc.) on the contact surface of the NMES
  • Complex regional pain syndrome (CRPS), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity
  • Having a pacemaker
  • Epilepsy
  • Malignancy

Treatment and study plan

Neuromuscular electrical stimulation

Other

NMES was performed using the Enraf Nonius Myomed 632X device. Both applications were performed 5 days/week for 4 weeks. NMES was performed with the patients in a sitting position and the affected arm resting on a table with the forearm supinated (Agonist group) / forearm pronated (Antagonist group). Surface electrodes (50x50 mm self-adhesive) were placed on the wrist and finger flexor/extensor muscle group. NMES parameters; Symmetric biphasic, pulse width 200 μs, on time 6 seconds (ramp up 1 second, ramp down 2 seconds), off time 12 seconds, stimulation intensity according to the patient's tolerance (not exceeding 90 mA), frequency 50 Hz and was adjusted to elicit contraction in the flexor and extensor muscles of the wrist and fingers.

Control (Standard treatment)

Other

In addition to conventional treatment, participants were included in an occupational rehabilitation program for 20 minutes to improve upper extremity functions.

Primary outcomes

  1. The Modified Ashworth Scale (MAS)

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    The Modified Ashworth Scale (MAS) is a clinical tool used to assess spasticity, which is characterized by increased muscle tone and resistance to passive movement. It is commonly applied in individuals with neurological conditions such as stroke, multiple sclerosis, or cerebral palsy. The scale involves passively moving a limb through its range of motion and evaluating the resistance felt. The scoring ranges from 0 to 4, where 0 indicates no increase in muscle tone, 1 represents a slight increase with a catch or minimal resistance at the end of the range, and 1+ reflects a catch followed by minimal resistance through less than half of the movement. A score of 2 denotes a more marked increase in tone through most of the range, but the limb remains movable. 3 indicates considerable resistance, making movement difficult, and 4 signifies a rigid limb with severe spasticity. This scale is widely used in rehabilitation to monitor spasticity and guide treatment interventions.

  2. Brunnstrom

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    The Brunnstrom Stages of Recovery describe the six stages of motor recovery following a stroke or brain injury. In Stage 1, there is flaccidity, with no voluntary movement or reflex activity in the affected limb. Stage 2 marks the beginning of spasticity, with the emergence of basic limb synergies and minimal voluntary movement. In Stage 3, spasticity reaches its peak, and voluntary control is limited to synergy patterns. Stage 4 involves a decrease in spasticity, with the appearance of some voluntary movements outside of synergy patterns. By Stage 5, spasticity continues to decline, and more complex and isolated movements become possible. Finally, in Stage 6, normal movement patterns are largely restored, with minimal or no spasticity and full control of isolated joint movements.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Effects of Neuromuscular Electrical Stimulation Applied to Agonist or Antagonist Muscles of the Upper Extremity on Flexor Spasticity and Function in Patients With Stroke

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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