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

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04913506
Collaborator
(none)
60
3
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group Mirror
  • Device: Group NMES
  • Other: Group Mirror+NMES
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, Randomized, Controlled, Single-Blinded StudyProspective, Randomized, Controlled, Single-Blinded Study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Fugl-Meyer Upper Extremity Motor Rating Scale [Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week]

      To analysis the increase in upper limb motor function

    2. Modified Tardieu Scale [Change from Baseline Modified Tardieu Scale at 3rd week]

      For spasticity

    3. Modified Ashworth Scale [Change from Baseline Modified Ashworth Scale at 3rd week]

      For spasticity

    4. Brunnstrom stages [Change from Baseline Brunnstrom stages at 3rd week]

      For improvement of upper limb motor function

    Secondary Outcome Measures

    1. Hospital Anxiety-Depression Scale (HADS) [Change from Baseline Hospital Anxiety-Depression Scale at 3rd week]

      For depression

    2. Mini-Mental Test [Change from Baseline Mini-Mental Test at 3rd week]

      for cognitive functions

    3. Numeric Rating Scale [Change from Baseline Numeric Rating Scale at 3rd week]

      for pain

    4. Pain Detect Questionnaire [Change from Baseline Pain Detect Questionnaire at 3rd week]

      for neuropathic pain

    5. Functional Independence Scale (FIM) [Change from Baseline Functional Independence Scale (FIM) at 3rd week]

      for daily life activities

    6. Ideomotor Apraxia Test [Change from Baseline Ideomotor Apraxia Test at 3rd week]

      for apraxia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Burcu Metin Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04913506
    Other Study ID Numbers:
    • BYIEAH-H
    First Posted:
    Jun 4, 2021
    Last Update Posted:
    Jun 4, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Burcu Metin Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 4, 2021