HemiplegiaNCT06770712
Mirror Therapy Combined With TENS for Motor Recovery in Paretic Upper Limbs of Chronic Stroke Patients
A study testing Mirror therapy and Transcutaneous Electrical Nerve Stimulation in people with Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine whether mirror therapy, applied in addition to bilateral upper extremity transcutaneous electrical nerve stimulation in patients with chronic stroke, has an additive effect on upper extremity motor recovery Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Mirror therapy and Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2023to 27 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a history of unilateral stroke
- Cases with a stroke duration of >6 months
- Brunnstrom stage for the upper extremity ≥3
- Brunnstrom stage for the hand ≥4
- Mini-mental test score >21
- Normal vision and hearing functions
Who cannot join
- Individuals with aphasia
- Individuals with neglect
- Those with a history of traumatic brain injury
- Individuals with uncontrolled cardiovascular disease
- Active inflammatory rheumatological or infectious diseases
- Individuals with significant upper extremity peripheral neuropathy
Show all 11Show fewer
- Those with severe sensory deficits
- Individuals with severe shoulder, elbow, wrist, or finger severe spasticity(Modified Ashworth Scale score of 4)
- Individuals with a cardiac pacemaker
- Those with lesions on the skin of the upper extremity
- Individuals with skin allergies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
T.C Sağlik Bilimleri Üniversitesi İstanbul Fizik Tedavi Rehabilitasyon Eğitim Ve Araştirma Hastanesi
Istanbul, BAHÇELİEVLER, 34212
About this study
Official title: Mirror Therapy as an Adjunct to Bilateral TENS for Improving Upper Extremity Motor Function in Chronic Stroke: A Randomized Controlled Trial
The aim of this study is to determine whether mirror therapy, applied in addition to bilateral upper extremity transcutaneous electrical nerve stimulation in patients with chronic stroke, has an additive effect on upper extremity motor recovery
Read the detailed description
A prospective, single-blind, randomized controlled clinical trial included 30 chronic stroke patients. The patients were assigned to the Mirror group (n=15) and the Control group (n=15) through block randomization.At the end of the three-month follow-up period, 11 patients in the Mirror group and 14 patients in the Control group completed the study. Both groups received conventional rehabilitation therapy for a total of 20 sessions (5 days a week for 4 weeks), along with 30 minutes of transcutaneous electrical nerve stimulation (TENS) applied bilaterally to the finger extensor muscles. In the Mirror group, mirror therapy was additionally administered following the TENS intervention.Upper extremity motor function was assessed by a blinded evaluator using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) at three time points: baseline, immediately post-treatment (1 month), and at follow-up (2 months after treatment completion).
The effect size (Cohen's d = 0.314) used to calculate the minimum sample size for detecting a significant difference between groups (Bi-TENS + Mirror therapy, Bi-TENS) was obtained from a previous study. (Peiming ve ark. 2021) The sample size was then calculated using the G*Power software version 3.1.9.4 (Franz Faul, University of Kiel, Germany), with an alpha error level of 0.05, a power of 0.95, an inter-correlation of 0.5, and a global non-correlation of 1. The total sample size required for this study was calculated to be 24. Assuming a dropout rate of 20%, the total sample size was determined to be 30.
The normality of the variables was assessed graphically and using the Shapiro-Wilk test. Data that followed a normal distribution were summarized as Mean ± Standard Deviation, while data that did not follow a normal distribution were summarized as Median and the interquartile range (Q1-Q3). Categorical variables were summarized as frequency (percentage). Comparisons of means between groups were performed using the Independent Samples t-test if the data followed a normal distribution, and the Mann-Whitney U test if the data did not follow a normal distribution. For categorical variables, comparisons between groups were made using the Chi-square test or Fisher's Exact test. Intra-group comparisons of means were performed using repeated measures ANOVA. Bonferroni correction was applied for post-hoc pairwise comparisons. A statistical significance level of p < 0.05 was considered. The data were statistically analyzed using the per-protocol approach. Additionally, the intention-to-treat analysis was performed using the Last Observation Carried Forward (LOCF) method. In the LOCF method, missing values are replaced with the last available observation for each participant Statistical analyses and calculations were performed using IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) and MS-Excel 2007.
- Conditions
- Hemiplegia
- Being tested
- Mirror therapy, Transcutaneous Electrical Nerve Stimulation
- Keywords
- Upper extremity motor function, TENS therapy, Mirror therapy, Fugl-Meyer Assessment, Functional improvement
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyOther
The patients were asked to sit in front of a table at an appropriate height and rest their arms on the table. A mirror was placed between both arms. The mirror was positioned so that the reflection of the healthy extremity overlapped with the paralytic extremity. In this way, the movements of the healthy upper extremity were viewed through the mirror, creating a visual movement illusion for the hemiplegic upper extremity. During the mirror therapy, exercises including forearm supination-pronation, wrist flexion-extension, finger flexion-extension, finger counting, grasping and releasing a cup, grasping and releasing a ball, and writing with a pen were performed. First, 30 minutes of bilateral TENS therapy were applied, followed by 30 minutes of mirror therapy
Transcutaneous Electrical Nerve StimulationDevice
Received stimulation on the extensor muscles of the hand fingers of both the intact and paretic sides, with a frequency of 100 Hz, pulse width of 200 microseconds, and a biphasic symmetric pulse for 30 minutes. The intensity of the current was adjusted to a level that produced a visible, comfortable muscle contraction. Self-adhesive electrodes, measuring 5x5 cm, were placed on the extensor surface of the forearm, 5 cm distal to the olecranon, parallel to the long axis of the muscle. Electrical stimulation was applied using the Cefar Rehab X2 device (DJO France SAS).
| Study group | Role | What they receive |
|---|---|---|
| Bilateral TENS+ Mirror therapy | Experimental | In addition to conventional treatment, the mirror therapy group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes. Following TENS therapy, 30 minutes of mirror therapy were administered in each session. Receives: Other: Mirror therapy; Device: Transcutaneous Electrical Nerve Stimulation |
| Bilateral TENS | Active comparator | In addition to conventional treatment, the control group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity
The Fugl-Meyer Motor Assessment Scale evaluates reflex activity, synergy, and non-synergistic patterns, as well as motor skills and coordination, reflecting the stages of motor development. This assessment consists of a total of 33 items, with each item scored on a 2-point scale. When scoring for the upper extremity, a participant can receive a maximum of 66 points. In the upper extremity assessment, a score of 53-66 points is classified as full capacity, 48-52 points as sufficient capacity, 32-47 points as limited capacity, and 31 points or below as weak capacity.
Measured: Change from baseline in the Fugl-Meyer Motor Assessment Scale immediately post-treatment (1 month) and 2 months after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start30 Oct 2023
- Primary completion2 Sep 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This study consists of two groups: the Mirror Group and the Control Group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep ÖZDEMİR, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İlhan KARACAN, Professor Doctor, Study director, T.C SAĞLIK BİLİMLERİ ÜNİVERSİTESİ İSTANBUL FİZİK TEDAVİ REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770712
- Sponsor's protocol ID
- 2023/273
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy as an Adjunct to Bilateral TENS for Improving Upper Extremity Motor Function in Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06770712
- Acronym / sponsor ID
- 2023/273
- Conditions
- Hemiplegia
- Keywords
- Upper extremity motor function, TENS therapy, Mirror therapy, Fugl-Meyer Assessment, Functional improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether mirror therapy, applied in addition to bilateral upper extremity transcutaneous electrical nerve stimulation in patients with chronic stroke, has an additive effect on upper extremity motor recovery
Detailed description
A prospective, single-blind, randomized controlled clinical trial included 30 chronic stroke patients. The patients were assigned to the Mirror group (n=15) and the Control group (n=15) through block randomization.At the end of the three-month follow-up period, 11 patients in the Mirror group and 14 patients in the Control group completed the study. Both groups received conventional rehabilitation therapy for a total of 20 sessions (5 days a week for 4 weeks), along with 30 minutes of transcutaneous electrical nerve stimulation (TENS) applied bilaterally to the finger extensor muscles. In the Mirror group, mirror therapy was additionally administered following the TENS intervention.Upper extremity motor function was assessed by a blinded evaluator using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) at three time points: baseline, immediately post-treatment (1 month), and at follow-up (2 months after treatment completion).
The effect size (Cohen's d = 0.314) used to calculate the minimum sample size for detecting a significant difference between groups (Bi-TENS + Mirror therapy, Bi-TENS) was obtained from a previous study. (Peiming ve ark. 2021) The sample size was then calculated using the G*Power software version 3.1.9.4 (Franz Faul, University of Kiel, Germany), with an alpha error level of 0.05, a power of 0.95, an inter-correlation of 0.5, and a global non-correlation of 1. The total sample size required for this study was calculated to be 24. Assuming a dropout rate of 20%, the total sample size was determined to be 30.
The normality of the variables was assessed graphically and using the Shapiro-Wilk test. Data that followed a normal distribution were summarized as Mean ± Standard Deviation, while data that did not follow a normal distribution were summarized as Median and the interquartile range (Q1-Q3). Categorical variables were summarized as frequency (percentage). Comparisons of means between groups were performed using the Independent Samples t-test if the data followed a normal distribution, and the Mann-Whitney U test if the data did not follow a normal distribution. For categorical variables, comparisons between groups were made using the Chi-square test or Fisher's Exact test. Intra-group comparisons of means were performed using repeated measures ANOVA. Bonferroni correction was applied for post-hoc pairwise comparisons. A statistical significance level of p < 0.05 was considered. The data were statistically analyzed using the per-protocol approach. Additionally, the intention-to-treat analysis was performed using the Last Observation Carried Forward (LOCF) method. In the LOCF method, missing values are replaced with the last available observation for each participant Statistical analyses and calculations were performed using IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) and MS-Excel 2007.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study consists of two groups: the Mirror Group and the Control Group.
| Arm | Type | Receives |
|---|---|---|
| Bilateral TENS+ Mirror therapy | Experimental | Other: Mirror therapy, Device: Transcutaneous Electrical Nerve StimulationIn addition to conventional treatment, the mirror therapy group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes. Following TENS therapy, 30 minutes of mirror therapy were administered in each session. |
| Bilateral TENS | Active comparator | Device: Transcutaneous Electrical Nerve StimulationIn addition to conventional treatment, the control group received TENS therapy on the finger extensor muscles of both the intact and paretic sides, five times a week for four weeks, with a total of 20 sessions, each lasting 30 minutes. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with a history of unilateral stroke
- Cases with a stroke duration of >6 months
- Brunnstrom stage for the upper extremity ≥3
- Brunnstrom stage for the hand ≥4
- Mini-mental test score >21
Key exclusion criteria (11 listed)
- Individuals with aphasia
- Individuals with neglect
- Those with a history of traumatic brain injury
- Individuals with uncontrolled cardiovascular disease
- Active inflammatory rheumatological or infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror therapyThe patients were asked to sit in front of a table at an appropriate height and rest their arms on the table. A mirror was placed between both arms. The mirror was positioned so that the reflection of the healthy extremity overlapped with the paralytic extremity. In this way, the movements of the healthy upper extremity were viewed through the mirror, creating a visual movement illusion for the hemiplegic upper extremity. During the mirror therapy, exercises including forearm supination-pronation, wrist flexion-extension, finger flexion-extension, finger counting, grasping and releasing a cup, grasping and releasing a ball, and writing with a pen were performed. First, 30 minutes of bilateral TENS therapy were applied, followed by 30 minutes of mirror therapy | Other | Bilateral TENS+ Mirror therapy |
| Transcutaneous Electrical Nerve StimulationReceived stimulation on the extensor muscles of the hand fingers of both the intact and paretic sides, with a frequency of 100 Hz, pulse width of 200 microseconds, and a biphasic symmetric pulse for 30 minutes. The intensity of the current was adjusted to a level that produced a visible, comfortable muscle contraction. Self-adhesive electrodes, measuring 5x5 cm, were placed on the extensor surface of the forearm, 5 cm distal to the olecranon, parallel to the long axis of the muscle. Electrical stimulation was applied using the Cefar Rehab X2 device (DJO France SAS). | Device | Bilateral TENS, Bilateral TENS+ Mirror therapy |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: Change from baseline in the Fugl-Meyer Motor Assessment Scale immediately post-treatment (1 month) and 2 months after treatment completion.
The Fugl-Meyer Motor Assessment Scale evaluates reflex activity, synergy, and non-synergistic patterns, as well as motor skills and coordination, reflecting the stages of motor development. This assessment consists of a total of 33 items, with each item scored on a 2-point scale. When scoring for the upper extremity, a participant can receive a maximum of 66 points. In the upper extremity assessment, a score of 53-66 points is classified as full capacity, 48-52 points as sufficient capacity, 32-47 points as limited capacity, and 31 points or below as weak capacity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlhan KARACAN, Professor Doctor study director
T.C SAĞLIK BİLİMLERİ ÜNİVERSİTESİ İSTANBUL FİZİK TEDAVİ REHABİLİTASYON EĞİTİM VE ARAŞTIRMA HASTANESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror therapy and Transcutaneous Electrical Nerve Stimulation in people with Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 11 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 21 May 2025. 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 Assessment for Upper Extremity (time frame: Change from baseline in the Fugl-Meyer Motor Assessment Scale immediately post-treatment (1 month) and 2 months after treatment completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.