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StrokeNCT06750692

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

A study testing Mirror Therapy, Low-Frequency Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Hand Therapy in people with Stroke and Upper Extremity Dysfunction, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Mirror Therapy, Low-Frequency Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Hand Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2025to 29 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Afyonkarahisar Health Sciences University

    Afyonkarahisar, 0300

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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).

Being tested
Mirror Therapy, Low-Frequency Repetitive Transcranial Magnetic Stimulation, Robot-Assisted Hand Therapy
Keywords
Mirror Therapy, Repetitive Transcranial Magnetic Stimulation, Hand-Finger Robot
Medical subject headings
Stroke, Neuralgia, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirror TherapyOther

    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.

  • Low-Frequency Repetitive Transcranial Magnetic StimulationDevice

    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.

  • Robot-Assisted Hand TherapyDevice

    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).

Study groups in NCT06750692
Study groupRoleWhat they receive
Mirror Therapy GroupExperimentalParticipants 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.
Receives: Other: Mirror Therapy
Low-Frequency rTMS GroupExperimentalParticipants 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.
Receives: Device: Low-Frequency Repetitive Transcranial Magnetic Stimulation
Robot-Assisted Hand Therapy GroupExperimentalParticipants 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.
Receives: Device: Robot-Assisted Hand Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Post-treatment (4th week)

Secondary outcomes (15)
  1. Brunnstrom Staging

    It is a test that evaluates the motor development of hemiplegic participants. In this test, the neurophysiological recovery process of the hemiplegic participant is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, stage without voluntary movement), and the highest stage is stage 6 (stage with isolated joint movement). In Brunnstrom staging, the hand and upper extremity are evaluated separately.

    Measured: Baseline and Post-treatment (4th week)

  2. Mini Mental Test

    It is a widely used cognitive screening test. The total score is 30 points. It has been stated that scores below 15 indicate low cognitive function, scores between 15-26 indicate medium, and scores above 26 indicate high cognitive level.

    Measured: Baseline

  3. Modified Ashworth Scale

    The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). Higher scores indicating sever spasticity.

    Measured: Baseline and Post-treatment (4th week)

  4. Box Block Test

    It is used to evaluate rough manual dexterity based on performance (time). 150 small wooden cubes are filled from the box with the participant's hand to be tested into the adjacent box. The participant is asked to throw one cube at a time into the semi-empty box. How many cubes are thrown in 60 seconds is counted. The result gives the score. How many cubes are thrown in 60 seconds is counted. The result gives the score. The higher the score, the higher the success rate.

    Measured: Baseline and Post-treatment (4th week)

  5. Nine Hole Peg Test

    This test measures dexterity based on performance (in seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the participant. Using the hand to be evaluated, the participant is asked to place the wooden sticks in the box into the holes on the panel as quickly as possible. Then, he is asked to put the sticks back into the box one by one. The completion time of the test is determined by a stopwatch. In this test, which evaluates manual dexterity based on performance, the success rate increases as the time gets short

    Measured: Baseline and Post-treatment (4th week)

  6. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is an 18 item questionnaire that assesses sleep quality and disturbances over the past month. The investigators will use the 3-factor scoring, which has been shown to have superior psychometric properties. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

    Measured: Baseline and Post-treatment (4th week)

  7. ABILHAND Stroke Hand Function Questionnaire

    The ABILHAND Hand Questionnaire was developed in 1998 to measure participant perceived dexterity. It contains 23 questions about how difficult the participant has to do the activities. impossible (0 points), difficult (1 point), easily (2 points) options is marked. The total score is 46.Higher scores indicate better hand functional recovery.

    Measured: Baseline and Post-treatment (4th week)

  8. Stroke Impact Scale

    The Stroke Impact Scale (SIS) is a stroke specific health status measure. It consists of a total of 59 items and 8 sections. The participant is asked to evaluate the difficulty experienced in completing each item in the last week on a five point Likert scale. A score of one indicates that the participant could not complete the item, and a score of five indicates that the participant had no difficulty in completing it. It also includes a visual analog scale (0: No improvement, 100: Complete recovery) regarding the general perception of recovery after stroke.

    Measured: Baseline and Post-treatment (4th week)

  9. Stroke Specific Quality of Life Scale

    Specific Quality Of Life scale (SSQOL) is a participant centered outcome measure intended to provide an assessment of health related quality of life specific to participants with stroke. The original test consists of 49 items encompassing 12 domains. Each item is ranked on a 5 point scale, with higher scores indicating better function.

    Measured: Baseline and Post-treatment (4th week)

  10. The Self Assessment of Neuropathic Symptoms and Signs (S-LANSS)

    The SLANSS scale is a scale that helps to distinguish neuropathic pain from nociceptive pain. Unlike the LANSS scale, the physician does not examine the participant in this scale, so it is easier to administer. The S-LANSS scale consists of a total of 7 questions. The participant fills in this scale on his/her own. The first 5 questions ask about pain symptoms, while the last 2 questions include the participant's self administered clinical examination. The answers to the questions are yes/no. Each question has a different score. The total score on the scale is 24. A total score of 12 or more indicates neuropathic pain.

    Measured: Baseline and Post-treatment (4th week)

  11. Beck Depression Scale

    The Beck Depression Scale is a 21 item self report inventory designed to assess the presence and severity in depressive symptoms. Each item is rated on a 4-point Likert type scale ranging from 0 to 3, based on the severity in the last two weeks. Higher scores indicating worse level of depression.

    Measured: Baseline and Post-treatment (4th week)

  12. Beck Anxiety Inventory

    The anxiety level of the participants was assessed using the Beck Anxiety Inventory (BAI). BAI is used to determine the severity of anxiety symptoms experienced by individuals. It is a Likert type scale with 21 headings that participants themselves score between 0-3, the score that can be obtained varies between 0-63, and the higher the score, the greater the anxiety experienced by the individual.

    Measured: Baseline and Post-treatment (4th week)

  13. Neuropathic Pain Questionnaire in 4 Questions

    ''Neuropathic Pain Questionnaire in 4 Questions'' is a short form designed to detect and diagnose neuropathic pain symptoms. The questionnaire consists of 10 questions to assess the symptoms experienced by the participant. These questions question signs and symptoms specific to neuropathic pain. A score between 0 and 10 is determined.

    Measured: Baseline and Post-treatment (4th week)

  14. Visual Analog Scale (VAS)

    The participant' musculoskeletal pain severity was assessed with the visual analog scale (VAS). The meanings of the numbers placed from 0 to 10 on a 10 cm line were explained to the participants. It was explained that no pain was 0, the most severe pain felt in life was 10, and moderate pain was 5 points. According to these explanations, the participants were asked to score their pain levels considering the last week.

    Measured: Baseline and Post-treatment (4th week)

  15. Neurophysiological Measurements

    Neurophysiologic evaluations of all participants will be performed twice before and 4 weeks after treatment. Participants will undergo MEP (motor evoked potential) measurement with TMS stimulation. The MagVenture MagPro R30 (Denmark) transcranial magnetic stimulation device in the Neuromodulation Unit will be used with Figure Eight Coil.

    Measured: Baseline and Post-treatment (4th week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start20 Jan 2025
  3. Primary completion20 Apr 2026
  4. Study completion29 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06750692
Sponsor's protocol ID
SBH2025
Status last verified
Jul 2026
First submitted
20 Dec 2024
Last updated
30 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31068898
  • 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.

    PubMed 38110138
  • 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.

    PubMed 32103968

Questions about this trial

What is this clinical trial studying?

A study testing Mirror Therapy, Low-Frequency Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Hand Therapy in people with Stroke and Upper Extremity Dysfunction, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl Meyer Upper Extremity Assessment Questionnaire (time frame: Baseline and Post-treatment (4th week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06750692, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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