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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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