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

NCT04913506 | Completed

• 1 other identifier: BYIEAH-H
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Upper Extremity Dysfunction

Keywords

hemiplegia; mirror theraphy; NMES

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Motor Rating Scale

  To analysis the increase in upper limb motor function Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Divided into 8 points for light touch and 16 points for position sense.

  Change from Baseline Fugl-Meyer Upper Extremity Motor Rating Scale at 3rd week

Secondary Outcomes (6)

• Mini-Mental Test

  Change from Baseline Mini-Mental Test at 3rd week

• Numeric Rating Scale

  Change from Baseline Numeric Rating Scale at 3rd week

• Pain Detect Questionnaire

  Change from Baseline Pain Detect Questionnaire at 3rd week

• Functional Independence Scale (FIM)

  Change from Baseline Functional Independence Scale (FIM) at 3rd week

• Modified Tardieu Scale

  Change from Baseline Modified Tardieu Scale at 3rd week

Study Arms (3)

Group Mirror

ACTIVE COMPARATOR

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

Group NMES

ACTIVE COMPARATOR

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

Group Mirror+NMES

ACTIVE COMPARATOR

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

Interventions

Group NMES 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)

Also known as: NMES (neuromuscular electrical stimulation)

Group NMES

Group Mirror+NMES 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)

Also known as: Mirror therapy+NMES

Group Mirror+NMES

Group Mirror 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)

Also known as: Mirror theraphy

Group Mirror

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burcu Metin Ökmen, M.D. Assoc. Prof

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Büşra Yeşil, M.D.

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, Randomized, Controlled, Single-Blinded Study

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

TU (1)