An interventional study of Mirror Therapy and Modified Constraint-Induced Movement Therapy in Stroke,Hemiplegia, sponsored by Nisa Kiliç Koçak. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Nisa Kiliç Koçak · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 16 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Nisa Kiliç Koçak as lead sponsor.
Counted across the registry records on this site, refreshed daily.
* Diagnosis: Confirmed first ischemic or hemorrhagic stroke with clinical and neurological evaluation.
Exclusion Criteria:
* Uncontrolled diabetes or other metabolic disorders.
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).
Other: Mirror Therapy
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).
Other: Modified Constraint-Induced Movement Therapy
Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
Also known as: Mirror Box Therapy, MT, Mirror Feedback Therapy
Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.
Also known as: mCIMT
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.
Time frame: 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.
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
Other Pre-Specified
The MMSE is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. It is used as a screening tool in this study to ensure participants possess the adequate cognitive capacity (a score of 20 or above) to understand and follow the rehabilitation protocols.
Time frame: Baseline (pre-treatment)
Modified Rankin Scale (mRS)
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of individuals who have suffered a stroke. It ranges from 0 (no symptoms at all) to 6 (dead), with lower scores indicating greater functional independence and less disability.
Time frame: Baseline (pre-treatment)
Plan to share: No — To protect participant confidentiality in accordance with institutional review board regulations and informed consent limitations.
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