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HemiplegiaNCT04913506

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

A study testing Group Mirror, Group NMES and Group Mirror+NMES in people with Hemiplegia and Upper Extremity Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hemiplegia, Upper Extremity Dysfunction
What is being tested?
Group Mirror, Group NMES and Group Mirror+NMES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    Bursa, 16320

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Being tested
Group Mirror, Group NMES, Group Mirror+NMES
Keywords
hemiplegia, mirror theraphy, NMES
Medical subject headings
Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group MirrorOther

    Also called Mirror theraphy

    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)

  • Group NMESDevice

    Also called NMES (neuromuscular electrical stimulation)

    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)

  • Group Mirror+NMESOther

    Also called Mirror therapy+NMES

    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)

Study groups in NCT04913506
Study groupRoleWhat they receive
Group MirrorActive comparatorAlong with conventional rehabilitation techniques, patients will be given ROM exercises in all directions, in front of the real mirror, by the practitioner on the healthy upper extremity for 30 minutes.
Receives: Other: Group Mirror
Group NMESActive comparatorAlong with conventional rehabilitation techniques, NMES will be applied to the hemiplegic arm for 30 minutes by the practitioner while the patients are sitting in a chair.
Receives: Device: Group NMES
Group Mirror+NMESActive comparatorIn addition to conventional rehabilitation techniques, patients will be given ROM exercises for 30 minutes in all directions in front of the real mirror to the healthy extremity, which the practitioner will synchronize with visual or auditory stimuli, and NMES treatment for 30 minutes to the paretic upper extremity.
Receives: Other: Group Mirror+NMES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Upper Extremity Motor Rating Scale

    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.

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

Secondary outcomes (6)

  1. Mini-Mental Test

    for cognitive functions

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

  2. Numeric Rating Scale

    for pain

    Measured: Change from Baseline Numeric Rating Scale at 3rd week

  3. Pain Detect Questionnaire

    for neuropathic pain

    Measured: Change from Baseline Pain Detect Questionnaire at 3rd week

  4. Functional Independence Scale (FIM)

    for daily life activities

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

  5. Modified Tardieu Scale

    Score, Description 0, No resistance during movement.

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

    Measured: Change from Baseline Modified Tardieu Scale at 3rd week

  6. Brunnstrom stages

    For improvement of upper limb motor function

    Measured: Change from Baseline Brunnstrom stages at 3rd week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Oct 2022
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, Randomized, Controlled, Single-Blinded Study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913506
Sponsor's protocol ID
BYIEAH-H
Status last verified
Feb 2026
First submitted
26 May 2021
Last updated
11 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Mirror, Group NMES and Group Mirror+NMES in people with Hemiplegia and Upper Extremity Dysfunction, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Upper Extremity Motor Rating Scale (time frame: Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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