Mirror Therapy for Complex Regional Pain Syndrome in Stroke Patients

NCT07537465 | Completed

• 1 other identifier: 2022.08.265
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Complex Regional Pain Syndrome I (CRPS I); Mirror Therapy

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity (Visual Analog Scale - VAS)

  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 Outcomes (9)

• Change in motor recovery (Brunnstrom Staging)

  Baseline and after 4 weeks

• Change in upper extremity motor function (Fugl-Meyer Assessment)

  Baseline and after 4 weeks

• Change in spasticity (Modified Ashworth Scale, MAS)

  Baseline and after 4 weeks

• Change in functional independence (Functional Independence Measure, FIM)

  Baseline and after 4 weeks

• Change in neuropathic pain (DN4)

  Baseline and after 4 weeks

Study Arms (2)

Mirror Therapy Group

EXPERIMENTAL

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

Sham Mirror Therapy Group

SHAM COMPARATOR

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

Interventions

Mirror Therapy BEHAVIORAL

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.

Mirror Therapy Group

Sham Mirror Therapy BEHAVIORAL

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.

Sham Mirror Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam&Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Complex Regional Pain Syndromes

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: October 1, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 15, 2023
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)