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

NCT06750692 | Completed

• 1 other identifier: SBH2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 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.

Conditions

Stroke; Upper Extremity Dysfunction; Neuropathic Pain; Quality of Life; Neurologic Disorder

Keywords

Mirror Therapy; Repetitive Transcranial Magnetic Stimulation; Hand-Finger Robot

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)

Study Arms (3)

Mirror Therapy Group

EXPERIMENTAL

Participants received mirror therapy in addition to conventional neurological rehabilitation. Both interventions were administered five days per week for four weeks, for a total of 20 sessions.

Other: Mirror Therapy

Low-Frequency rTMS Group

EXPERIMENTAL

Participants received low-frequency repetitive transcranial magnetic stimulation in addition to conventional neurological rehabilitation. Both interventions were administered five days per week for four weeks, for a total of 20 sessions.

Device: Low-Frequency Repetitive Transcranial Magnetic Stimulation

Robot-Assisted Hand Therapy Group

EXPERIMENTAL

Participants received robot-assisted hand therapy using the AMADEO device in addition to conventional neurological rehabilitation. Both interventions were administered five days per week for four weeks, for a total of 20 sessions.

Device: Robot-Assisted Hand Therapy

Interventions

Mirror Therapy 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.

Mirror Therapy Group

Low-Frequency Repetitive Transcranial Magnetic Stimulation 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.

Low-Frequency rTMS Group

Robot-Assisted Hand Therapy 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).

Robot-Assisted Hand Therapy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 0300, Turkey (Türkiye)

Location

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.

  PMID: 31068898 BACKGROUND

• 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.

  PMID: 38110138 BACKGROUND

• Gandhi 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.

  PMID: 32103968 BACKGROUND

MeSH Terms

Conditions

Stroke; Neuralgia; Nervous System Diseases

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Selma Eroglu, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers were not blinded because of the distinct nature of the interventions. Investigators and outcome assessors remained blinded to treatment allocation until completion of all outcome assessments. Personnel administering the interventions were not involved in participant assessment or outcome evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomized in a 1:1:1 ratio to one of three parallel intervention groups: mirror therapy, low-frequency repetitive transcranial magnetic stimulation, or robot-assisted hand therapy. Each intervention was administered in addition to the same conventional neurological rehabilitation program.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 20, 2025
• Primary Completion: April 20, 2026
• Study Completion: July 29, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (1)