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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04913506
Enrollment
42
Registered
2021-06-04
Start date
2021-06-01
Completion date
2023-01-01
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Upper Extremity Dysfunction

Keywords

hemiplegia, mirror theraphy, NMES

Brief 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.

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.

Interventions

OTHERGroup Mirror

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)

DEVICEGroup NMES

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)

OTHERGroup Mirror+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)

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Prospective, Randomized, Controlled, Single-Blinded Study

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Extremity Motor Rating ScaleChange from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd weekTo 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

MeasureTime frameDescription
Mini-Mental TestChange from Baseline Mini-Mental Test at 3rd weekfor cognitive functions
Numeric Rating ScaleChange from Baseline Numeric Rating Scale at 3rd weekfor pain
Pain Detect QuestionnaireChange from Baseline Pain Detect Questionnaire at 3rd weekfor neuropathic pain
Functional Independence Scale (FIM)Change from Baseline Functional Independence Scale (FIM) at 3rd weekfor daily life activities
Modified Tardieu ScaleChange from Baseline Modified Tardieu Scale at 3rd weekScore, 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).
Brunnstrom stagesChange from Baseline Brunnstrom stages at 3rd weekFor improvement of upper limb motor function

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORBurcu Metin Ökmen, M.D. Assoc. Prof

Bursa Yuksek Ihtisas Training and Research Hospital

STUDY_CHAIRBüşra Yeşil, M.D.

Bursa Yuksek Ihtisas Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026