- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07537465
Mirror Therapy for Complex Regional Pain Syndrome in Stroke Patients (MT-CRPS-ST)
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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Başakşehir Çam&Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
|
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
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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
|
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.
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What is the study measuring?
Primary Outcome Measures
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
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
|
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Change in upper extremity motor function (Fugl-Meyer Assessment)
Time Frame: Baseline and after 4 weeks
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Upper extremity motor function will be evaluated using the Fugl-Meyer Assessment before and after treatment.
|
Baseline and after 4 weeks
|
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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.
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Baseline and after 4 weeks
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Change in functional independence (Functional Independence Measure, FIM)
Time Frame: Baseline and after 4 weeks
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Functional independence will be assessed using the Functional Independence Measure before and after treatment.
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Baseline and after 4 weeks
|
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Change in neuropathic pain (DN4)
Time Frame: Baseline and after 4 weeks
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Neuropathic pain will be evaluated using the DN4 questionnaire before and after treatment.
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Baseline and after 4 weeks
|
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Change in neuropathic pain (LANSS)
Time Frame: Baseline and after 4 weeks
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Neuropathic pain will be evaluated using the LANSS scale before and after treatment.
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Baseline and after 4 weeks
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Change in sympathetic nervous system function (sympathetic skin response)
Time Frame: Baseline and after 4 weeks
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Sympathetic nervous system function will be evaluated using sympathetic skin response measurements before and after treatment.
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Baseline and after 4 weeks
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Change in cutaneous silent period (CSP)
Time Frame: Baseline and after 4 weeks
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Cutaneous silent period will be measured to evaluate electrophysiological changes before and after treatment.
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Baseline and after 4 weeks
|
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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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Stroke
- Complex Regional Pain Syndromes
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Mirror Movement Therapy
Other Study ID Numbers
- 2022.08.265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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