- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546864
Comparative Effects of Mirror Therapy and Cognitive Orientation to Daily Occupational Performance in Stroke: A Randomized Controlled Trial
Comparative Effects of Mirror Therapy, Cognitive Orientation to Daily Occupational Performance, and Conventional Occupational Therapy in Individuals With Stroke: A 3-Month Follow-Up Randomized Controlled Trial
This study aims to compare the effectiveness of three rehabilitation approaches in individuals with stroke: mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), and conventional occupational therapy (COT), all combined with robotic balance training.
A total of 45 individuals with subacute and chronic stroke will be randomly assigned to one of three groups. Each group will receive 4 weeks of intervention (5 sessions per week), followed by a 3-month follow-up period.
Outcomes related to motor function, somatosensory function, activities of daily living, participation, and quality of life will be assessed at baseline, after intervention, and at follow-up.
The study aims to determine which intervention approach is more effective in improving functional outcomes in individuals with stroke.
Study Overview
Status
Conditions
Detailed Description
Stroke is one of the leading causes of disability worldwide, often resulting in motor, sensory, and cognitive impairments. Rehabilitation approaches that enhance neuroplasticity are essential for improving functional recovery.
This randomized controlled trial aims to compare the effectiveness of mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), and conventional occupational therapy (COT), all combined with robotic balance training (RBT), in individuals with stroke.
Participants will be recruited from a physical therapy and rehabilitation unit and will be randomly assigned into three groups: MT, CO-OP, and COT. All groups will receive robotic balance training as a priming intervention prior to therapy sessions.
Each intervention will be administered for 4 weeks, 5 days per week. In addition, a transfer package will be applied to enhance the generalization of therapeutic gains to daily life activities.
Outcome measures will include motor function, somatosensory function, occupational performance, activities of daily living, participation, self-efficacy, and quality of life. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up.
The findings of this study are expected to provide evidence for the comparative effectiveness of different rehabilitation approaches in stroke and contribute to clinical decision-making.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: NURTEN BİLGİN, PhD Student
- Phone Number: +905546366542
- Email: nurtenncek@gmail.com
Study Locations
-
-
Merkez
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Bayburt, Merkez, Turkey (Türkiye), 69000
- Recruiting
- Bayburt State Hospital
-
Contact:
- NURTEN BİLGİN, PhD Student
- Phone Number: 05546366542
- Email: nurtenncek@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Individuals diagnosed with ischemic or hemorrhagic stroke
- Age 18 years and older
- Subacute (3-6 months post-stroke) or chronic stage (6-12 months post-stroke)
- Brunnstrom Motor Recovery Stage ≥3 for upper extremity, ≥4 for hand, and ≥4 for lower extremity
- Mini-Mental State Examination (MMSE) score ≥24
- No severe visual, orthopedic, or additional neurological impairments
- Not participating in another study during the research period
- Voluntary consent to participate in the study
Exclusion Criteria:
- - Poor motor coordination or major medical problems that would prevent participation
- Presence of Wernicke's aphasia
- Botulinum toxin injection within the last 3 months
- Psychiatric conditions that may interfere with participation (e.g., depression, ongoing psychiatric treatment, low motivation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mirror Therapy Group
Participants in this group will receive mirror therapy combined with robotic balance training.
Mirror therapy will be applied using task-oriented activities involving upper and lower extremities based on individual needs.
Intervention will be administered 5 days per week for 4 weeks.
A transfer package will also be applied.
|
Mirror therapy involves the use of a mirror to create a visual illusion of movement of the affected limb by observing the reflection of the unaffected limb.
Task-oriented activities are performed to improve motor function and sensory integration in individuals with stroke.
Robotic balance training is used as a priming intervention before therapy sessions.
It includes repetitive, task-specific movements involving weight shifting, postural control, and balance training to enhance motor responses.
|
|
Experimental: CO-OP Group
Participants in this group will receive cognitive orientation to daily occupational performance (CO-OP) combined with robotic balance training.
Individualized goals will be determined and cognitive strategies will be used to improve task performance.
Intervention will be administered 5 days per week for 4 weeks.
A transfer package will also be applied.
|
Robotic balance training is used as a priming intervention before therapy sessions.
It includes repetitive, task-specific movements involving weight shifting, postural control, and balance training to enhance motor responses.
CO-OP is a client-centered, performance-based approach that uses cognitive strategies to enable skill acquisition.
Participants identify meaningful goals and use guided discovery and problem-solving strategies to improve task performance.
|
|
Active Comparator: Conventional Occupational Therapy Group
Participants in this group will receive conventional occupational therapy combined with robotic balance training.
The intervention will include task-oriented activities such as reaching, grasping, coordination, and strengthening exercises.
Intervention will be administered 5 days per week for 4 weeks.
A transfer package will also be applied.
|
Robotic balance training is used as a priming intervention before therapy sessions.
It includes repetitive, task-specific movements involving weight shifting, postural control, and balance training to enhance motor responses.
Conventional occupational therapy includes task-oriented interventions such as reaching, grasping, coordination training, strengthening exercises, and activities aimed at improving functional independence in daily living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Motor Assessment (FMA)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
The Fugl-Meyer Assessment will be used to evaluate motor function in individuals with stroke.
Higher scores indicate better motor function.
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Nottingham Sensory Assessment (rNSA)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess somatosensory function including tactile sensation and proprioception.
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
|
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess Occupational Performance .
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
|
Modified Barthel Index (MBI)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess activity daily of life
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
|
Stroke Impact Scale (SIS)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess quality of life
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
|
Stroke Self-Efficacy Questionnaire (SSEQ)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess self-efficacy
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
|
Community Integration Questionnaire (CIQ)
Time Frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Used to assess paticipation
|
Baseline, post-intervention (4 weeks), and 3-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gokcen Akyurek, Associate Professor, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT_COOP_STROKE_2026_NB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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