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

NCT ID: NCT04913506

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Hemiplegia Upper Extremity Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Randomized, Controlled, Single-Blinded Study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Group Mirror

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Group NMES

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Group Mirror+NMES

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

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)

Intervention Type DEVICE

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)

Intervention Type OTHER

Other Intervention Names

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Mirror theraphy NMES (neuromuscular electrical stimulation) Mirror therapy+NMES

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Burcu Metin Ökmen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Metin Ökmen, M.D. Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Büşra Yeşil, M.D.

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Central Contacts

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Burcu Metin Ökmen, M.D.Assoc. Prof

Role: CONTACT

+902242955000

Other Identifiers

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BYIEAH-H

Identifier Type: -

Identifier Source: org_study_id

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