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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegia; Upper Extremity Dysfunction
• Intervention / Treatment: Other: Group Mirror; Device: Group NMES; Other: Group Mirror+NMES

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burcu Metin Ökmen, M.D.Assoc. Prof; Phone Number: +902242955000; Email: burcumetinokmen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Mirror; Along 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.	Other: Group 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); Other Names: Mirror theraphy
Active Comparator: Group NMES; Along 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.	Device: Group 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); Other Names: NMES (neuromuscular electrical stimulation)
Active Comparator: Group Mirror+NMES; In 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.	Other: Group 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); Other Names: Mirror therapy+NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Upper Extremity Motor Rating Scale	To analysis the increase in upper limb motor function	Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week
Modified Tardieu Scale	For spasticity	Change from Baseline Modified Tardieu Scale at 3rd week
Modified Ashworth Scale	For spasticity	Change from Baseline Modified Ashworth Scale at 3rd week
Brunnstrom stages	For improvement of upper limb motor function	Change from Baseline Brunnstrom stages at 3rd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety-Depression Scale (HADS)	For depression	Change from Baseline Hospital Anxiety-Depression Scale at 3rd week
Mini-Mental Test	for cognitive functions	Change from Baseline Mini-Mental Test at 3rd week
Numeric Rating Scale	for pain	Change from Baseline Numeric Rating Scale at 3rd week
Pain Detect Questionnaire	for neuropathic pain	Change from Baseline Pain Detect Questionnaire at 3rd week
Functional Independence Scale (FIM)	for daily life activities	Change from Baseline Functional Independence Scale (FIM) at 3rd week
Ideomotor Apraxia Test	for apraxia	Change from Baseline Ideomotor Apraxia Test at 3rd week

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Burcu Metin Ökmen, M.D. Assoc. Prof, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital; Study Chair: Büşra Yeşil, M.D., University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 29, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: hemiplegia; mirror theraphy; NMES
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: BYIEAH-H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No