Stroke,HemiplegiaNCT07668349
Effects of Modified Constraint-Induced Movement Therapy and Mirror Therapy in Hemiplegic Stroke
A study testing Mirror Therapy and Modified Constraint-Induced Movement Therapy in people with Stroke,Hemiplegia, run by Nisa Kiliç Koçak at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate and compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT) on upper extremity motor functions, activity participation, and independence in daily living activities among hemiplegic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke,Hemiplegia
- What is being tested?
- Mirror Therapy and Modified Constraint-Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * Diagnosis: Confirmed first ischemic or hemorrhagic stroke with clinical and neurological evaluation.
- Time Since Stroke: 3 to 24 months post-stroke onset.
- Hemiplegia: Significant motor deficit in the affected upper extremity.
- Motor Function Level: Presence of mild to moderate motor impairment in the affected upper extremity (FMA-UE score appropriate for the application of modified CIMT and mirror therapy).
- Cognitive Status: Adequate cognitive capacity to understand and follow the study protocols (Mini-Mental State Examination score of 20 or above).
- Visual Perception: Adequate visual perception to perform mirror therapy.
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- Comorbidities: Absence of severe coexisting medical conditions that prevent participation (e.g., uncontrolled cardiovascular diseases, severe psychiatric disorders).
- Prior Treatments: No prior intensive participation in the interventions investigated in this study (modified CIMT or mirror therapy).
- Consent: Voluntary agreement to participate and signed informed consent form.
Who cannot join
- * Uncontrolled diabetes or other metabolic disorders.
- Progressive non-stroke neurological diseases (e.g., Parkinson's disease, multiple sclerosis).
- Terminal illness or short life expectancy.
- Severe cognitive impairment preventing comprehension or execution of the study protocols (e.g., advanced dementia).
- Severe visual impairment that prevents mirror therapy application (e.g., uncorrected visual acuity loss, neglect).
- Severe visuospatial perception disorders making it difficult to perceive or interpret the mirror image.
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- Absence or minimal level of active movement in the affected upper extremity (limiting the applicability of modified CIMT).
- Significant motor deficit in the unaffected upper extremity.
- Severe and uncontrolled spasticity in the upper extremity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akay Special Education and Rehabilitation Center
Kastamonu, Merkez, 37100
Nisa KILIÇ KOÇAK, physiotherapist, +905455932547, nisakilicas12@gmail.com
About this study
Official title: Comparison of the Effects of Modified Constraint-Induced Movement Therapy and Mirror Therapy Applied to the Upper Extremity on Motor Function, Participation, and Independence in Activities of Daily Living in Hemiplegic Stroke Patients: A Randomized Controlled Trial
The purpose of this study is to investigate and compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT) on upper extremity motor functions, activity participation, and independence in daily living activities among hemiplegic stroke patients. Participants diagnosed with stroke will be randomly assigned to intervention groups. The study aims to determine which therapeutic modality provides a higher contribution to the functional recovery of the paretic upper limb and overall quality of life.
Read the detailed description
Background and Rationale:
Upper extremity impairment is one of the most common and disabling consequences of stroke, severely limiting independence in daily living and restricting social participation. Neuroplasticity-based interventions, such as Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT), are widely recognized for their potential to facilitate cortical reorganization. However, comparative evidence regarding their specific impacts on multi-dimensional recovery patterns (motor function vs. activity integration) remains limited. This study aims to provide a comprehensive head-to-head comparison of mCIMT and MT in a structured clinical environment.
Methodology \& Protocol:
This study is designed as a prospective, randomized, controlled, single-blind clinical trial. Following formal ethical approval (OMU KAEK 2025/640) and obtained informed consent, eligible hemiplegic stroke patients will be screened and randomly allocated into the intervention arms.
All participants will receive standard medical care and baseline conventional physical therapy. The intervention groups will be structured as follows:
Modified Constraint-Induced Movement Therapy (mCIMT) Group: Participants will have their unaffected upper extremity constrained using a specialized mitt or splint for a designated period daily, combined with intensive, repetitive, task-oriented training of the paretic upper limb.
Mirror Therapy (MT) Group: Participants will perform structured, bilateral upper extremity tasks while observing the non-affected limb's movements in a mirror box, creating a visual illusion of normal movement in the paretic limb.
Outcome Measures:
Assessment sessions will be conducted at baseline (pre-treatment) and immediately following the completion of the intervention protocol (post-treatment) by a blinded assessor. Upper extremity motor functions will be evaluated using standardized neurological and functional scales. Secondary outcomes will include clinical assessments of activity participation and the level of independence achieved in activities of daily living.
- Conditions
- Stroke,Hemiplegia
- Being tested
- Mirror Therapy, Modified Constraint-Induced Movement Therapy
- Keywords
- Stroke Rehabilitation, Constraint-Induced Movement Therapy, Mirror Therapy, Upper Extremity
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
Also called Mirror Box Therapy, MT, Mirror Feedback Therapy
Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
Modified Constraint-Induced Movement TherapyOther
Also called mCIMT
Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy Group | Experimental | Stroke patients in this group will receive mirror therapy in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training). Receives: Other: Mirror Therapy |
| Modified CIMT Group | Experimental | Stroke patients in this group will receive modified Constraint-Induced Movement Therapy (modified CIMT) targeting the affected upper extremity, in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training). Receives: Other: Modified Constraint-Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
The FMA-UE is an index used to assess sensorimotor function in stroke patients. It evaluates reflex activity, volitional movement, and coordination of the upper extremity. The total score ranges from 0 to 66, with higher scores indicating better upper extremity motor function.
Measured: Baseline (pre-treatment) and 4 weeks (post-treatment)
Stroke Rehabilitation Assessment of Movement (STREAM)
The STREAM is a clinical measure of motor functioning for stroke patients. It evaluates upper limb movements, lower limb movements, and basic mobility. The total score ranges from 0 to 30 for each subscale, with higher scores reflecting better motor performance and mobility.
Measured: Baseline (pre-treatment) and 4 weeks (post-treatment)
Secondary outcomes (3)
Functional Independence Measure (FIM)
The FIM is an 18-item instrument used to assess the physical and cognitive disability of patients and track their changes during rehabilitation. It measures independent performance in self-care, sphincter control, transfers, locomotion, communication, and social cognition. Total scores range from 18 to 126, where higher scores indicate greater functional independence.
Measured: Baseline (pre-treatment) and 4 weeks (post-treatment)
Motor Activity Log-28 (MAL-28)
The MAL-28 is a semi-structured interview used to assess the real-world use of the affected upper extremity in stroke patients. It includes two subscales: the Amount of Use (AOU) and the Quality of Movement (QOM) across 28 daily activities. Scores for each subscale range from 0 to 5, with higher scores indicating more frequent or better quality of upper limb use in daily life.
Measured: Baseline (pre-treatment) and 4 weeks (post-treatment)
Impact on Participation and Autonomy (IPA)
The IPA is a patient-reported outcome measure designed to assess perceived participation and autonomy in individuals with chronic conditions. It evaluates dimensions such as autonomy indoors/outdoors, family role, social relations, and work/education. Higher subscale scores reflect greater restrictions or poorer perceived participation and autonomy.
Measured: Baseline (pre-treatment) and 4 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start19 Feb 2026
- Primary completion20 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke,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
- The sample size was calculated using PASS 15.0 based on an effect size of Cohen's $d = 0.468$ obtained from the study by Hsieh et al. (2014), an alpha level of 0.05, and a power of 80%. As a result of the power analysis, a minimum of 8 participants per group, making a total of 16 participants, is required.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nisa Kiliç Koçak
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Nisa Kiliç Koçak, Ondokuz Mayıs University
- Investigators
- BİRCAN YÜCEKAYA, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668349
- Sponsor's protocol ID
- OMÜ KAEK 2025/640
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant confidentiality in accordance with institutional review board regulations and informed consent limitations.
Publications
Saygili F, Guclu-Gunduz A, Eldemir S, Eldemir K, Ozkul C, Gursoy GT. Effects of modified-constraint induced movement therapy based telerehabilitation on upper extremity motor functions in stroke patients. Brain Behav. 2024 Jun;14(6):e3569. doi: 10.1002/brb3.3569.
PubMed 38873866
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Modified Constraint-Induced Movement Therapy and Mirror Therapy Applied to the Upper Extremity on Motor Function, Participation, and Independence in Activities of Daily Living in Hemiplegic Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07668349
- Acronym / sponsor ID
- OMÜ KAEK 2025/640
- Conditions
- Stroke,Hemiplegia
- Keywords
- Stroke Rehabilitation, Constraint-Induced Movement Therapy, Mirror Therapy, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Nisa Kiliç KoçakUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (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 purpose of this study is to investigate and compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT) on upper extremity motor functions, activity participation, and independence in daily living activities among hemiplegic stroke patients. Participants diagnosed with stroke will be randomly assigned to intervention groups. The study aims to determine which therapeutic modality provides a higher contribution to the functional recovery of the paretic upper limb and overall quality of life.
Detailed description
Background and Rationale:
Upper extremity impairment is one of the most common and disabling consequences of stroke, severely limiting independence in daily living and restricting social participation. Neuroplasticity-based interventions, such as Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT), are widely recognized for their potential to facilitate cortical reorganization. However, comparative evidence regarding their specific impacts on multi-dimensional recovery patterns (motor function vs. activity integration) remains limited. This study aims to provide a comprehensive head-to-head comparison of mCIMT and MT in a structured clinical environment.
Methodology \& Protocol:
This study is designed as a prospective, randomized, controlled, single-blind clinical trial. Following formal ethical approval (OMU KAEK 2025/640) and obtained informed consent, eligible hemiplegic stroke patients will be screened and randomly allocated into the intervention arms.
All participants will receive standard medical care and baseline conventional physical therapy. The intervention groups will be structured as follows:
Modified Constraint-Induced Movement Therapy (mCIMT) Group: Participants will have their unaffected upper extremity constrained using a specialized mitt or splint for a designated period daily, combined with intensive, repetitive, task-oriented training of the paretic upper limb.
Mirror Therapy (MT) Group: Participants will perform structured, bilateral upper extremity tasks while observing the non-affected limb's movements in a mirror box, creating a visual illusion of normal movement in the paretic limb.
Outcome Measures:
Assessment sessions will be conducted at baseline (pre-treatment) and immediately following the completion of the intervention protocol (post-treatment) by a blinded assessor. Upper extremity motor functions will be evaluated using standardized neurological and functional scales. Secondary outcomes will include clinical assessments of activity participation and the level of independence achieved in activities of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample size was calculated using PASS 15.0 based on an effect size of Cohen's $d = 0.468$ obtained from the study by Hsieh et al. (2014), an alpha level of 0.05, and a power of 80%. As a result of the power analysis, a minimum of 8 participants per group, making a total of 16 participants, is required.
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy Group | Experimental | Other: Mirror TherapyStroke patients in this group will receive mirror therapy in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training). |
| Modified CIMT Group | Experimental | Other: Modified Constraint-Induced Movement TherapyStroke patients in this group will receive modified Constraint-Induced Movement Therapy (modified CIMT) targeting the affected upper extremity, in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- * Diagnosis: Confirmed first ischemic or hemorrhagic stroke with clinical and neurological evaluation.
Key exclusion criteria (9 listed)
- * Uncontrolled diabetes or other metabolic disorders.
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 TherapyAlso: Mirror Box Therapy, MT, Mirror Feedback TherapyMirror therapy protocols targeting upper extremity motor functions for 4 weeks. | Other | Mirror Therapy Group |
| Modified Constraint-Induced Movement TherapyAlso: mCIMTModified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks. | Other | Modified CIMT Group |
Primary outcome
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The FMA-UE is an index used to assess sensorimotor function in stroke patients. It evaluates reflex activity, volitional movement, and coordination of the upper extremity. The total score ranges from 0 to 66, with higher scores indicating better upper extremity motor function.
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The STREAM is a clinical measure of motor functioning for stroke patients. It evaluates upper limb movements, lower limb movements, and basic mobility. The total score ranges from 0 to 30 for each subscale, with higher scores reflecting better motor performance and mobility.
3 secondary outcomes
Functional Independence Measure (FIM)
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
Motor Activity Log-28 (MAL-28)
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
Impact on Participation and Autonomy (IPA)
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 38873866Saygili F, Guclu-Gunduz A, Eldemir S, Eldemir K, Ozkul C, Gursoy GT. Effects of modified-constraint induced movement therapy based telerehabilitation on upper extremity motor functions in stroke patients. Brain Behav. 2024 Jun;14(6):e3569. doi: 10.1002/brb3.3569.
- Individual participant dataSharing planned: No. To protect participant confidentiality in accordance with institutional review board regulations and informed consent limitations.
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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.
BİRCAN YÜCEKAYA study director
Ondokuz Mayıs University
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 Modified Constraint-Induced Movement Therapy in people with Stroke,Hemiplegia, run by Nisa Kiliç Koçak 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NİSA KILIÇ KOÇAK, Msc Student (+905455932547, nisakilicas12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) (time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)). The study lists 2 primary outcomes in all. 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 NCT07668349, which also lists 1 linked publication.
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 25 Jun 2026.