Clinical trial NCT04913506: Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation
Official title: Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia
Upper Extremity Dysfunction
Keywords: hemiplegia
mirror theraphy
NMES
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Controlled, Single-Blinded Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Motor Rating Scale
timeFrame: Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week
measure: Modified Tardieu Scale
timeFrame: Change from Baseline Modified Tardieu Scale at 3rd week
measure: Modified Ashworth Scale
timeFrame: Change from Baseline Modified Ashworth Scale at 3rd week
measure: Brunnstrom stages
timeFrame: Change from Baseline Brunnstrom stages at 3rd week
Secondary outcomes:
measure: Hospital Anxiety-Depression Scale (HADS)
timeFrame: Change from Baseline Hospital Anxiety-Depression Scale at 3rd week
measure: Mini-Mental Test
timeFrame: Change from Baseline Mini-Mental Test at 3rd week
measure: Numeric Rating Scale
timeFrame: Change from Baseline Numeric Rating Scale at 3rd week
measure: Pain Detect Questionnaire
timeFrame: Change from Baseline Pain Detect Questionnaire at 3rd week
measure: Functional Independence Scale (FIM)
timeFrame: Change from Baseline Functional Independence Scale (FIM) at 3rd week
measure: Ideomotor Apraxia Test
timeFrame: Change from Baseline Ideomotor Apraxia Test at 3rd week
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Burcu Metin Ökmen, M.D. Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Büşra Yeşil, M.D.
role: STUDY_CHAIR
References: