Mirror Therapy and Cross-Education of Muscle Strength

May 11, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Additive Effect of Mirror Therapy on Effects of Cross-Education of Muscle Strength of Neuromuscular Electrical Stimulation In Hemiplegic Patients

This study was conducted to determine whether mirror therapy has an additive effect on cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic patients was measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 29 patients, 7 women, and 22 men were included according to the inclusion and exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES, mirror therapy was applied to the experimental group simultaneously with NMES. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34173
        • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cases with stroke duration ≥ 1 month
  • Ability to walk at least 10m (functional ambulation scale ≥3)
  • Age range 18-75 years
  • Hemorrhagic or ischemic stroke
  • Brunnstrom stage ≥4 for lower limb
  • Unilateral stroke
  • Cooperating with the examination and tests

Exclusion Criteria:

  • Mini Mental State Assessment score <21
  • Severe spasticity (MAS = 4) in ankle dorsiflexors
  • Have a contracture on ankle joint
  • The presence of skin lesions in the application area
  • Painful pathologies in the lower extremities
  • Having visual field defects
  • Active inflammatory, rheumatological or infectious disease
  • Parent rhythm / conduction block problem in the heart
  • Uncontrollable hypertension (Maxima> 140, Minima> 90)
  • Presence of lower extremity fracture
  • Peripheral nerve lesions such as polyneuropathy, radiculopathy
  • Finding or suspected active deep vein thrombosis
  • History of deep vein thrombosis and pulmonary embolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mirror Therapy
Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors. In addition to this application, mirror therapy was applied simultaneously with NMES.
Device: Mirror frame
Combined Mirror and NMES therapy
Placebo Comparator: Control
Participants were asked to sit with their knee joints in full extension and both ankle joints in a neutral position. Five sessions of neuromuscular electrical stimulation (NMES) were applied to the non-affected side ankle dorsiflexors.
Device: Control
Only NMES therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of ankle dorsiflexor isometric muscle strength
Time Frame: Change from Baseline muscle strength at 6 days
Force transducer used for measuring maximum voluntary ankle dorsiflexion force. The force unit is kilogram.force
Change from Baseline muscle strength at 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Lower Extremity Brunnstrom score
Time Frame: Change from Baseline Brunnstrom score at 6 days
It evaluates the developmental stages of synergy patterns, muscle tone and isolated movements of the patients in the lower extremities. Patients are categorized between Stage-1 and 6. Stage 1: Flaccidity; Stage 6: Spasticity Disappears and Coordination Reappears
Change from Baseline Brunnstrom score at 6 days
Change of Modified Ashworth Scale score
Time Frame: Change from Baseline Modified Ashworth Scale score at 6 days
Modified Ashworth Scale was used for assessment spasticity. Modified Ashworth Scale scores are varied between 0 and 4: 0 points, no increase in muscle tone; 4 points indicate spasticity with a degree of rigidity.
Change from Baseline Modified Ashworth Scale score at 6 days
Change of Functional Ambulation Scale score
Time Frame: Change from Baseline Functional Ambulation Scale score at 6 days
The Functional Ambulation Classification (FAC) is a method for classifying mobility. The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent).
Change from Baseline Functional Ambulation Scale score at 6 days
Change of Timed Up and Go Test score
Time Frame: Change from Baseline Timed Up and Go Test score at 6 days
It is a test that evaluates the patient's static and dynamic balance, mobility and walking ability. The test's score is the time in seconds it takes the subject takes to complete the test.
Change from Baseline Timed Up and Go Test score at 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Ilhan Karacan, Assoc Prof, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPMRTRH-MT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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