Başakşehir Çam&Sakura City Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT07537465
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Time frame: Baseline and after 4 weeks
Motor recovery will be assessed using Brunnstrom Staging before and after treatment.
Time frame: Baseline and after 4 weeks
Upper extremity motor function will be evaluated using the Fugl-Meyer Assessment before and after treatment.
Time frame: Baseline and after 4 weeks
Spasticity will be assessed using the Modified Ashworth Scale before and after treatment.
Time frame: Baseline and after 4 weeks
Functional independence will be assessed using the Functional Independence Measure before and after treatment.
Time frame: Baseline and after 4 weeks
Neuropathic pain will be evaluated using the DN4 questionnaire before and after treatment.
Time frame: Baseline and after 4 weeks
Neuropathic pain will be evaluated using the LANSS scale before and after treatment.
Time frame: Baseline and after 4 weeks
Sympathetic nervous system function will be evaluated using sympathetic skin response measurements before and after treatment.
Time frame: Baseline and after 4 weeks
Cutaneous silent period will be measured to evaluate electrophysiological changes before and after treatment.
Time frame: Baseline and after 4 weeks
Subcutaneous tissue thickness will be measured using ultrasonography before and after treatment.
Başakşehir Çam & Sakura City Hospital
Other Gov
Efficacy of Mirror Therapy for Complex Regional Pain Syndrome in Post-Stroke Patients
Acronym: MT-CRPS-ST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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