Clinical trial NCT06750692: Comparison of the Effects of Mirror Therapy,rTMS and Robotic-assisted Hand Therapy in Stroke Patients
Official title: Comparison of the Effects of Mirror Therapy,repetitive Transcranial Magnetic Stimulation and Robotic-assisted Hand Therapy Added to Neurological Rehabilitation on Upper Extremity Functions, Quality of Life and Pain in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Dysfunction
Neuropathic Pain
Quality of Life
Neurologic Disorder
Keywords: Mirror Therapy
Repetitive Transcranial Magnetic Stimulation
Hand-Finger Robot
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Stroke is the second leading cause of death in adults and an important cause of long term disability. Functional limitations that develop in the post stroke period affect participants quality of life and activities of daily living. Today, despite advances in rehabilitation and new pharmacologic strategies, stroke related upper extremity function, quality of life and pain treatment may not always achieve the desired results. There are new approaches in stroke rehabilitation such as mirror therapy, Repetitive Transcranial Magnetic Stimulation, robot-assisted hand therapy. Three groups will take part in this study. All three groups will receive a total of 20 sessions of conventional neurological rehabilitation program 5 days a week for 4 weeks. In addition to the first group, a total of 20 sessions of upper extremity mirror therapy program will be applied for 4 weeks, 5 sessions per week. The second group will receive Repetitive Transcranial Magnetic Stimulation (rTMS) to the contralateral M1 upper extremity motor cortex region at low frequency (1Hz) and at an intensity of 100%-110 of the resting motor threshold, 5 sessions per week for a total of 20 sessions for 4 weeks. The third group will receive a total of 20 sessions of robot-assisted hand therapy using AMADEO (Tyromotion Austria) 5 days a week for 4 weeks.These three groups will be compared in terms of upper extremity function, quality of life and pain.Brunstroom, Mini Mental Test, Modified Ashworth Scale, Fugl Meyer Upper Extremity Motor Assessment Scale, Box Block Test, Nine Hole Pag Test, ABILHAND Stroke Hand Function Questionnaire, Stroke Impact Questionnaire, Stroke Specific Quality of Life Scale, Visual Analog Scale , LANNS neuropathic pain assessment scale, 4 Question Neuropathic Pain Questionnaire, Beck Depression Inventory, Beck Anxiety Scale, Pittsburgh Sleep Quality Index, MEP (motor evoked potential) measurement will be done . Participants will be evaluated by a physician twice at the beginning and at the end of treatment (4th week).

Eligibility criteria: Inclusion Criteria:

* Patients who applied to Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Polyclinic with the diagnosis of hemiplegia after a cerebrovascular accident in the inpatient ward or as an outpatient for neurological rehabilitation after taking the anamnesis and physical examination, who met the inclusion criteria and eliminated the exclusion criteria
* 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

Exclusion Criteria:

* 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
* orthopedic injuries that may limit maximum effort capacity
* brain lesion or drug use history that may affect the seizure threshold
* increased intracranial pressure
* uncontrolled migraine
* severe spasticity in the hand (MAS≥3)
* contracture in the hand
* have had a fracture or surgery on the hemiplegic side in the last 6 months
* severe visual impairment
* severe depression

Primary outcomes:
measure: Fugl Meyer Upper Extremity Assessment Questionnaire
timeFrame: Baseline and Post-treatment (4th week)
Secondary outcomes:
measure: Brunnstrom Staging
timeFrame: Baseline and Post-treatment (4th week)
measure: Mini Mental Test
timeFrame: Baseline
measure: Modified Ashworth Scale
timeFrame: Baseline and Post-treatment (4th week)
measure: Box Block Test
timeFrame: Baseline and Post-treatment (4th week)
measure: Nine Hole Peg Test
timeFrame: Baseline and Post-treatment (4th week)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Post-treatment (4th week)
measure: ABILHAND Stroke Hand Function Questionnaire
timeFrame: Baseline and Post-treatment (4th week)
measure: Stroke Impact Scale
timeFrame: Baseline and Post-treatment (4th week)
measure: Stroke Specific Quality of Life Scale
timeFrame: Baseline and Post-treatment (4th week)
measure: The Self Assessment of Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: Baseline and Post-treatment (4th week)
measure: Beck Depression Scale
timeFrame: Baseline and Post-treatment (4th week)
measure: Beck Anxiety Inventory
timeFrame: Baseline and Post-treatment (4th week)
measure: Neuropathic Pain Questionnaire in 4 Questions
timeFrame: Baseline and Post-treatment (4th week)
measure: Visual Analog Scale (VAS)
timeFrame: Baseline and Post-treatment (4th week)
measure: Neurophysiological Measurements
timeFrame: Baseline and Post-treatment (4th week)
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Selma Eroglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suganuma Y, Shimode C, Yamamoto H. Conjugation in Tetrahymena: formation of a special junction area for conjugation during the co-stimulation period. J Electron Microsc (Tokyo). 1984;33(1):10-8. No abstract available.
citation: Jia 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.
citation: The presidents. Frank Abbott, 1887-1888. J Am Dent Assoc. 1981 Apr;102(4):471. No abstract available.