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Completed

NCT Number: NCT04913506

Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation

In this study, it was aimed to evaluate whether or not NMES in front of the mirror brings an additional benefit to mirror therapy alone or NMES alone on upper extremity motor and functional development, spasticity, anxiety, depression, cognitive function and activities of daily living, and neuropathic pain.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

About this study

Cerebrovascular diseases are the general name given to clinical neurological pictures that occur as a result of pathological changes in the blood vessels of the primary lesion and / or in the properties of the blood passing through them. Many complications develop in the acute and chronic periods in patients with stroke, and the rate of complication development has been reported to vary between 40-96% in different studies. The aim of hemiplegic upper extremity rehabilitation is to prevent complications and improve lost motor-sensory control. Upper limb rehabilitation is less successful than lower limb rehabilitation because the upper limb is more functional and more complex.

For muscle reeducation, NMES is used to strengthen inhibited muscle groups, facilitate voluntary isolated muscle contraction, prevent muscle atrophy, increase metabolism and enzyme activity, change the contractile properties of the muscle, maintain or increase the normal range of motion of the joint, develop voluntary movement and functional gains. NMES has been used in hemiplegia rehabilitation since 1960 for the purpose of functional retraining of muscles. The purpose of this treatment is to enable the muscles with impaired neural function of the electrical current to perform a functional and useful movement.

Applications in front of the mirror are thought to trigger the neuronal connections in the motor cortex associated with the imagined movement. Findings obtained from studies with functional magnetic resonance support this theory. Compared to conventional PR, applications in front of the mirror are thought to have more and longer-lasting effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subacute hemiplegia
  • Patients who can communicate well, are motivated enough and are willing to participate in the study
  • Patients' medical conditions are stable
  • Initiation of voluntary extension movement in the wrist (lower limit)

Exclusion criteria

  • The presence of more than one previous cerebrovascular disease (except transient ischemic attack).
  • Presence of flaccid hemiplegia.
  • Presence of a previous neurological disease causing a decrease in strength in the affected extremity.
  • Presence of deformity due to a previous fracture, inflammatory arthropathy, etc. in the affected extremity.
  • Presence of more than grade 3 spasticity in upper extremity according to Modified Ashworth Scale
  • Use of cardiac pace maker
  • Presence of fatal cardiac arrhythmia
  • Presence of seizure history within 2 years.

Treatment and study plan

Group Mirror

Other

For 30 minutes, ROM exercises will be applied to the solid upper extremity in all directions in front of a real mirror by the practitioner. (3 weeks, 5 days a week, 15 sessions in total)

Other names: Mirror theraphy

Group NMES

Device

NMES will be applied to the hemiplegic arm(deltoid, elbow extensors and forearm) for 30 minutes by the practitioner (3 weeks, 5 days a week, 15 sessions in total)

Other names: NMES (neuromuscular electrical stimulation)

Group Mirror+NMES

Other

The practitioner will be synchronized with visual or auditory stimuli, and ROM exercises in all directions in front of the real mirror for 30 minutes, and NMES therapy for 30 minutes on the paretic upper extremity will be applied together. (3 weeks, 5 days a week, 15 sessions in total)

Other names: Mirror therapy+NMES

Primary outcomes

  1. Fugl-Meyer Upper Extremity Motor Rating Scale

    Time frame: Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week

    To analysis the increase in upper limb motor function Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Divided into 8 points for light touch and 16 points for position sense.

Secondary outcomes

  1. Mini-Mental Test

    Time frame: Change from Baseline Mini-Mental Test at 3rd week

    for cognitive functions

  2. Numeric Rating Scale

    Time frame: Change from Baseline Numeric Rating Scale at 3rd week

    for pain

  3. Pain Detect Questionnaire

    Time frame: Change from Baseline Pain Detect Questionnaire at 3rd week

    for neuropathic pain

  4. Functional Independence Scale (FIM)

    Time frame: Change from Baseline Functional Independence Scale (FIM) at 3rd week

    for daily life activities

  5. Modified Tardieu Scale

    Time frame: Change from Baseline Modified Tardieu Scale at 3rd week

    Score, Description 0, No resistance during movement.

    • There is very slight resistance during movement, but no noticeable "catch".
    • There is a noticeable "catch" at a certain angle, followed by relaxation.
    • Clonus occurring at a certain angle and lasting for seconds (ending with fatigue).
    • Uninterrupted clonus occurring at a certain angle and lasting for more than 10 seconds. 5, The joint is too stiff to move (petrified).
  6. Brunnstrom stages

    Time frame: Change from Baseline Brunnstrom stages at 3rd week

    For improvement of upper limb motor function

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 4, 2021
Registry last updated
Feb 11, 2026

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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