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

Primary Purpose

Hemiplegia, Upper Extremity Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group Mirror
Group NMES
Group Mirror+NMES
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring hemiplegia, mirror theraphy, NMES

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group Mirror

    Group NMES

    Group Mirror+NMES

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer Upper Extremity Motor Rating Scale
    To analysis the increase in upper limb motor function
    Modified Tardieu Scale
    For spasticity
    Modified Ashworth Scale
    For spasticity
    Brunnstrom stages
    For improvement of upper limb motor function

    Secondary Outcome Measures

    Hospital Anxiety-Depression Scale (HADS)
    For depression
    Mini-Mental Test
    for cognitive functions
    Numeric Rating Scale
    for pain
    Pain Detect Questionnaire
    for neuropathic pain
    Functional Independence Scale (FIM)
    for daily life activities
    Ideomotor Apraxia Test
    for apraxia

    Full Information

    First Posted
    May 26, 2021
    Last Updated
    May 29, 2021
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04913506
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    June 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia, Upper Extremity Dysfunction
    Keywords
    hemiplegia, mirror theraphy, NMES

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, Randomized, Controlled, Single-Blinded Study
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Mirror
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group NMES
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group Mirror+NMES
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Group Mirror
    Other Intervention Name(s)
    Mirror theraphy
    Intervention Description
    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
    Device
    Intervention Name(s)
    Group NMES
    Other Intervention Name(s)
    NMES (neuromuscular electrical stimulation)
    Intervention Description
    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
    Other
    Intervention Name(s)
    Group Mirror+NMES
    Other Intervention Name(s)
    Mirror therapy+NMES
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer Upper Extremity Motor Rating Scale
    Description
    To analysis the increase in upper limb motor function
    Time Frame
    Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week
    Title
    Modified Tardieu Scale
    Description
    For spasticity
    Time Frame
    Change from Baseline Modified Tardieu Scale at 3rd week
    Title
    Modified Ashworth Scale
    Description
    For spasticity
    Time Frame
    Change from Baseline Modified Ashworth Scale at 3rd week
    Title
    Brunnstrom stages
    Description
    For improvement of upper limb motor function
    Time Frame
    Change from Baseline Brunnstrom stages at 3rd week
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety-Depression Scale (HADS)
    Description
    For depression
    Time Frame
    Change from Baseline Hospital Anxiety-Depression Scale at 3rd week
    Title
    Mini-Mental Test
    Description
    for cognitive functions
    Time Frame
    Change from Baseline Mini-Mental Test at 3rd week
    Title
    Numeric Rating Scale
    Description
    for pain
    Time Frame
    Change from Baseline Numeric Rating Scale at 3rd week
    Title
    Pain Detect Questionnaire
    Description
    for neuropathic pain
    Time Frame
    Change from Baseline Pain Detect Questionnaire at 3rd week
    Title
    Functional Independence Scale (FIM)
    Description
    for daily life activities
    Time Frame
    Change from Baseline Functional Independence Scale (FIM) at 3rd week
    Title
    Ideomotor Apraxia Test
    Description
    for apraxia
    Time Frame
    Change from Baseline Ideomotor Apraxia Test at 3rd week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Burcu Metin Ökmen, M.D.Assoc. Prof
    Phone
    +902242955000
    Email
    burcumetinokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Burcu Metin Ökmen, M.D. Assoc. Prof
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Büşra Yeşil, M.D.
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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