Comparison of the Effects of Mirror Therapy,rTMS and Robotic-assisted Hand Therapy in Stroke Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim of the study is to investigate the comparison of the effects of mirror therapy, Repetitive Transcranial Magnetic Stimulation and robot-assisted hand therapy added to conventional neurological rehabilitation on upper extremity function, quality of life and pain in stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
December 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2026
ExpectedMarch 12, 2026
March 1, 2026
1.3 years
December 20, 2024
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl Meyer Upper Extremity Assessment Questionnaire
The Fugl Meyer Upper Extremity Motor Assessment Scale was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66. A range of data is available for the minimum clinically important differences for the FMUE Scale. A change of 4 to 7 points in chronic stroke, 12 points in subacute stroke, and 9 to 10 points is considered clinically significant.Higher scores indicate better upper limb functional recovery.
Baseline and Post-treatment (4th week)
Secondary Outcomes (15)
Brunnstrom Staging
Baseline and Post-treatment (4th week)
Mini Mental Test
Baseline
Modified Ashworth Scale
Baseline and Post-treatment (4th week)
Box Block Test
Baseline and Post-treatment (4th week)
Nine Hole Peg Test
Baseline and Post-treatment (4th week)
- +10 more secondary outcomes
Study Arms (3)
Experimental: Mirror therapy
EXPERIMENTALThe first group of participants will receive mirror therapy for 4 weeks, 5 sessions per week for a total of 20 sessions of upper extremity mirror therapy.
Experimental: Low Frequency rTMS Protocol
EXPERIMENTALThe second group will receive a total of 20 sessions of Repetitive Transcranial Magnetic Stimulation (rTMS) to the contralateral M1 upper extremity motor cortex region at low frequency (1Hz) and intensity of 100%-110% of the resting motor threshold, 5 sessions per week for 4 weeks.
Experimental: Robotic-assisted hand therapy
EXPERIMENTALIn the Robot Assisted Therapy group, a total of 20 sessions will be applied to the hemiplegic upper extremity with AMADEO (Tyromotion Austria) 5 days a week for 4 weeks.
Interventions
The first group of participants will receive a total of 20 sessions of upper extremity mirror therapy program, 5 sessions per week for 4 weeks.
Repetitive Transcranial Magnetic Stimulation (rTMS) will be applied at an intensity of 100-110% of the resting motor threshold and low frequency (1 Hz) to the contralateral M1 upper extremity motor cortex region for a total of 20 sessions, 5 sessions per week for 4 weeks. rTMS application is planned to provide magnetic stimulation with the stimulator of the Magventure MagPro R30 device.
In the Robot Assisted Therapy group, a total of 20 sessions will be applied 5 days a week for 4 weeks using continuous passive range of motion, active assistive exercise and play therapy programs for hemiplegic upper extremities with AMADEO (Tyromotion Austria).
Eligibility Criteria
You may not qualify if:
- Female and male patients between the ages of 40-80
- stroke at least 3 months ago
- voluntarily agreed to participate in the study regularly, whose health status is suitable for rehabilitation and who are medically stable
- mini mental test score of 15 and above
- Neurologically stable patient
- significant comorbidities such as serious heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension
- history of epilepsy, antiepileptic drug use
- intracranial metal objects
- intraauricular implants
- cognitive dysfunction
- upper extremity peripheral nerve injuries
- malignancy
- active infection
- skin infections or open wounds in the application area
- inflammatory diseases
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Afyonkarahisar Health Sciences University
Afyonkarahisar, 0300, Turkey (Türkiye)
Related Publications (3)
Duret C, Grosmaire AG, Krebs HI. Robot-Assisted Therapy in Upper Extremity Hemiparesis: Overview of an Evidence-Based Approach. Front Neurol. 2019 Apr 24;10:412. doi: 10.3389/fneur.2019.00412. eCollection 2019.
BACKGROUNDJia F, Zhao Y, Wang Z, Chen J, Lu S, Zhang M. Effect of Graded Motor Imagery Combined With Repetitive Transcranial Magnetic Stimulation on Upper Extremity Motor Function in Stroke Patients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 May;105(5):819-825. doi: 10.1016/j.apmr.2023.12.002. Epub 2023 Dec 17.
PMID: 38110138BACKGROUNDGandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selma Eroglu, MD
Afyonkarahisar Health Sciences University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Single-Blinded Prospective Randomized Trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 20, 2024
First Posted
December 27, 2024
Study Start
December 27, 2024
Primary Completion
April 20, 2026
Study Completion (Estimated)
June 20, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03