Comparison of the Effects of Mirror Therapy,rTMS and Robotic-assisted Hand Therapy in Stroke Patients

NCT ID: NCT06750692

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-27

Study Completion Date

2026-06-20

Brief Summary

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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

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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).

Conditions

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Stroke Upper Extremity Dysfunction Neuropathic Pain Quality of Life Neurologic Disorder

Keywords

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Mirror Therapy Repetitive Transcranial Magnetic Stimulation Hand-Finger Robot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Single-Blinded Prospective Randomized Trial

Study Groups

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Experimental: Mirror therapy

The 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.

Group Type EXPERIMENTAL

Procedure: Mirror therapy

Intervention Type OTHER

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.

Experimental: Low Frequency rTMS Protocol

The 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.

Group Type EXPERIMENTAL

Device: Low Frequency rTMS Protocol

Intervention Type DEVICE

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.

Experimental: Robotic-assisted hand therapy

In 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.

Group Type EXPERIMENTAL

Robotic-assisted hand therapy

Intervention Type 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).

Interventions

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Procedure: Mirror therapy

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.

Intervention Type OTHER

Device: Low Frequency rTMS Protocol

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.

Intervention Type DEVICE

Robotic-assisted hand therapy

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Selma Eroğlu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selma Eroglu, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

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Afyonkarahisar Health Sciences University

Afyonkarahisar, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sanberk Beklen, MD

Role: CONTACT

Phone: +905388465535

Email: [email protected]

Selma Eroglu, MD

Role: CONTACT

Phone: +905052421591

Email: [email protected]

Facility Contacts

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Sanberk Beklen, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 6491567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38110138 (View on PubMed)

The presidents. Frank Abbott, 1887-1888. J Am Dent Assoc. 1981 Apr;102(4):471. No abstract available.

Reference Type BACKGROUND
PMID: 7012218 (View on PubMed)

Other Identifiers

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SBH2025

Identifier Type: -

Identifier Source: org_study_id