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

Hemiplegia Clinical Trial

Official title:

Evaluation of the Effects of Neuromuscular Electrical Stimulation and Mirror Therapy in Hemiplegia Rehabilitation; Prospective, Randomized, Controlled, Single-Blinded Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04913506
• Other study ID #: BYIEAH-H
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Burcu Metin Ökmen, M.D.Assoc. Prof
• Phone: +902242955000
• Email: burcumetinokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Upper Extremity Dysfunction

Intervention

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)

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:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Modified Tardieu Scale	For spasticity	Change from Baseline Modified Tardieu Scale at 3rd week
Primary	Modified Ashworth Scale	For spasticity	Change from Baseline Modified Ashworth Scale at 3rd week
Primary	Brunnstrom stages	For improvement of upper limb motor function	Change from Baseline Brunnstrom stages at 3rd week
Secondary	Hospital Anxiety-Depression Scale (HADS)	For depression	Change from Baseline Hospital Anxiety-Depression Scale at 3rd week
Secondary	Mini-Mental Test	for cognitive functions	Change from Baseline Mini-Mental Test at 3rd week
Secondary	Numeric Rating Scale	for pain	Change from Baseline Numeric Rating Scale at 3rd week
Secondary	Pain Detect Questionnaire	for neuropathic pain	Change from Baseline Pain Detect Questionnaire at 3rd week
Secondary	Functional Independence Scale (FIM)	for daily life activities	Change from Baseline Functional Independence Scale (FIM) at 3rd week
Secondary	Ideomotor Apraxia Test	for apraxia	Change from Baseline Ideomotor Apraxia Test at 3rd week