Stroke,Hemiplegia
Conditions
Keywords
Stroke Rehabilitation, Constraint-Induced Movement Therapy, Mirror Therapy, Upper Extremity
Brief 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. 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.
Interventions
OTHERMirror Therapy
Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.
Sponsors
Nisa Kiliç Koçak
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \* 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. * 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.
Exclusion criteria
* \* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment-Upper Extremity (FMA-UE) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | Baseline (pre-treatment) and 4 weeks (post-treatment) | 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. |
| Motor Activity Log-28 (MAL-28) | Baseline (pre-treatment) and 4 weeks (post-treatment) | 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. |
| Impact on Participation and Autonomy (IPA) | Baseline (pre-treatment) and 4 weeks (post-treatment) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNİSA KILIÇ KOÇAK, Msc Student
CONTACTBİRCAN YÜCEKAYA, Asst.Prof.Dr
STUDY_DIRECTORBİRCAN YÜCEKAYA
Ondokuz Mayıs University
Outcome results
None listed