Mirror Therapy for Complex Regional Pain Syndrome in Stroke Patients (MT-CRPS-ST)

April 16, 2026 updated by: Beyza Ozturk, Başakşehir Çam & Sakura City Hospital

Efficacy of Mirror Therapy for Complex Regional Pain Syndrome in Post-Stroke Patients

The goal of this clinical study is to evaluate the effectiveness of mirror therapy in treating complex regional pain syndrome (CRPS) in patients after stroke using clinical assessments, electrophysiological evaluations, and ultrasonographic measurements by comparing pre- and post-treatment outcomes.

The main questions it aims to answer are:

Does mirror therapy lead to improvements in clinical outcomes in post-stroke patients with CRPS when assessed before and after treatment? Does mirror therapy reduce pain, improve motor function, and enhance functional independence based on clinical assessments? Does mirror therapy reduce swelling (edema) in the affected limb as measured by ultrasonographic evaluations? Does mirror therapy lead to changes in sympathetic nervous system function as assessed by electrophysiological evaluations?

Researchers will compare mirror therapy to sham mirror therapy (a similar procedure without therapeutic effect) to determine its effectiveness.

Participants will:

Be randomly assigned to either a mirror therapy group or a control group Receive conventional rehabilitation therapy and contrast bath treatment for 4 weeks Receive either mirror therapy or sham mirror therapy for 20 minutes daily Be evaluated before and after treatment using clinical scales, electrophysiological tests, and ultrasonographic measurements.

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

Complex regional pain syndrome (CRPS) is a challenging complication following stroke, characterized by pain, edema, autonomic dysfunction, and impaired motor function. It significantly affects rehabilitation outcomes and quality of life. Despite various treatment approaches, optimal management remains difficult. Mirror therapy has emerged as a non-invasive rehabilitation technique that provides visual feedback and may influence cortical reorganization and pain modulation. Additionally, it may have effects on autonomic function, particularly the sympathetic nervous system.

This prospective, randomized, single-blind study was conducted in the inpatient Physical Medicine and Rehabilitation clinic of Başakşehir Çam and Sakura City Hospital between October 2022 and October 2023. Patients with post-stroke CRPS who met the inclusion criteria were enrolled and randomly assigned to either a mirror therapy group or a control group. Both groups received a standardized conventional rehabilitation program and contrast bath therapy. The intervention group additionally received mirror therapy, while the control group received sham mirror therapy.

The aim of the study was to evaluate the clinical effectiveness of mirror therapy in post-stroke CRPS through a multidimensional approach. Clinical status, functional outcomes, electrophysiological parameters related to sympathetic nervous system function, and ultrasonographic measurements of soft tissue changes were assessed before and after the intervention period.

This study provides comprehensive evaluation of mirror therapy effects by combining clinical assessments with objective electrophysiological and imaging-based measurements. The findings are expected to contribute to the understanding of the role of mirror therapy in the management of CRPS after stroke and to support its use as an accessible and complementary rehabilitation approach.

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.
40

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 (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Başakşehir Çam&Sakura City 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a first-ever ischemic or hemorrhagic stroke
  • Time since stroke onset of ≤ 12 months
  • Diagnosed with Complex Regional Pain Syndrome (CRPS) Type 1 according to the Budapest criteria
  • In the dystrophic stage (Stage 2) of CRPS
  • Mini-Mental State Examination (MMSE) score > 24
  • Brunnstrom upper extremity-hand stage between 1 and 4
  • Age between 18 and 65 years

Exclusion Criteria:

  • Unstable medical condition
  • Presence of neglect
  • Severe aphasia preventing completion of assessment scales
  • Presence of a concomitant lower motor neuron lesion
  • History of fracture, surgery, or amputation in the affected limb
  • Presence of implanted electronic devices (e.g., cardiac pacemaker)
  • Local infection at the application site
  • Use of oral steroids or pregabalin/gabapentin within the last 3 months
  • History of intra-articular injection, botulinum toxin injection, or suprascapular nerve block within the last 3 months

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.
Experimental: Mirror Therapy Group
Participants in this arm received conventional rehabilitation therapy and contrast bath therapy for 4 weeks in addition to mirror therapy for 20 minutes daily
Behavioral: Mirror Therapy
Mirror therapy was applied for 20 minutes daily for 4 weeks in addition to a conventional rehabilitation program and contrast bath therapy. Patients performed movements of the unaffected upper limb while watching its reflection in a mirror positioned in the mid-sagittal plane, creating the illusion of movement in the affected limb.
Sham Comparator: Sham Mirror Therapy Group
Participants in this arm received conventional rehabilitation therapy and contrast bath therapy for 4 weeks in addition to sham mirror therapy for 20 minutes daily
Behavioral: Sham Mirror Therapy
Sham mirror therapy was applied for 20 minutes daily for 4 weeks in addition to a conventional rehabilitation program and contrast bath therapy. The non-reflective side of the mirror was used so that no visual feedback of the affected limb was provided, and patients performed similar movements without the mirror illusion.

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 in pain intensity (Visual Analog Scale - VAS)
Time Frame: Baseline and after 4 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS) before and after the 4-week treatment period.
Baseline and after 4 weeks

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 in motor recovery (Brunnstrom Staging)
Time Frame: Baseline and after 4 weeks
Motor recovery will be assessed using Brunnstrom Staging before and after treatment.
Baseline and after 4 weeks
Change in upper extremity motor function (Fugl-Meyer Assessment)
Time Frame: Baseline and after 4 weeks
Upper extremity motor function will be evaluated using the Fugl-Meyer Assessment before and after treatment.
Baseline and after 4 weeks
Change in spasticity (Modified Ashworth Scale, MAS)
Time Frame: Baseline and after 4 weeks
Spasticity will be assessed using the Modified Ashworth Scale before and after treatment.
Baseline and after 4 weeks
Change in functional independence (Functional Independence Measure, FIM)
Time Frame: Baseline and after 4 weeks
Functional independence will be assessed using the Functional Independence Measure before and after treatment.
Baseline and after 4 weeks
Change in neuropathic pain (DN4)
Time Frame: Baseline and after 4 weeks
Neuropathic pain will be evaluated using the DN4 questionnaire before and after treatment.
Baseline and after 4 weeks
Change in neuropathic pain (LANSS)
Time Frame: Baseline and after 4 weeks
Neuropathic pain will be evaluated using the LANSS scale before and after treatment.
Baseline and after 4 weeks
Change in sympathetic nervous system function (sympathetic skin response)
Time Frame: Baseline and after 4 weeks
Sympathetic nervous system function will be evaluated using sympathetic skin response measurements before and after treatment.
Baseline and after 4 weeks
Change in cutaneous silent period (CSP)
Time Frame: Baseline and after 4 weeks
Cutaneous silent period will be measured to evaluate electrophysiological changes before and after treatment.
Baseline and after 4 weeks
Change in subcutaneous tissue thickness (ultrasonography)
Time Frame: Baseline and after 4 weeks
Subcutaneous tissue thickness will be measured using ultrasonography before and after treatment.
Baseline and after 4 weeks

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.
Başakşehir Çam & Sakura City Hospital

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.
October 1, 2022

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.
October 10, 2023

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.
October 15, 2023

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).
April 10, 2026

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.
April 16, 2026

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.
April 17, 2026

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.
April 17, 2026

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.
April 16, 2026

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.
April 1, 2026

More Information

Terms related to this study

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.
  • 2022.08.265

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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