- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435688
Comparison of the Effectiveness of Mirror Therapy and Mirror Mode of Hand Robot in Stroke (mirror_robot)
Comparison of The Effectiveness Of Mirror Therapy And Mirror Mode of a Hand Robot in Upper Extremity Motor Recovery After Stroke
The goal of this clinical trial is to compare the effectiveness of conventional mirror therapy and robotic mirror mode training in promoting upper extremity motor recovery in adult patients with ischemic stroke during the early subacute phase. The main questions it aims to answer are:
Does mirror mode of a robotic hand device result in greater motor function recovery compared to conventional mirror therapy?
Are there differences between the groups in somatosensory improvement and gross motor skill outcomes?
Do both intervention modalities result in clinically significant improvements in motor and functional outcomes?
Researchers will compare a conventional mirror therapy group and a robotic-assisted mirror mode group to determine which provides more significant gains in motor function, somatosensory input, and functional use of the paretic arm.
Participants will:
Receive standard physiotherapy sessions for 6 weeks
Be randomly assigned to either mirror therapy or robotic mirror mode intervention
Be evaluated using Fugl-Meyer Assessment, ARAT, Box and Block Test, Wolf Motor Function Test and Tactile/proprioceptive sensory test using Fugl-Meyer Assessment Sensory subsection.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upper extremity motor impairment is one of the leading causes of functional disability following stroke. Although conventional therapies promote some degree of recovery, restoring hand function remains a major challenge, particularly in patients with severe paresis. Mirror therapy has been widely used due to its affordability and portability. However, proprioceptive feedback limitations and the potential mismatch between visual and somatosensory input reduce its effectiveness.
This study investigates an innovative approach that combines visual illusion and proprioceptive input using a robotic hand device in mirror mode. The robotic intervention is designed to synchronize joint motion with visual feedback, potentially enhancing the mirror neuron system's activation and promoting neuroplastic changes more efficiently than conventional mirror therapy.
The study will be conducted over a 6-week period with stroke patients in the early subacute phase. Both groups will receive equivalent durations of upper limb training in addition to conventional physiotherapy.
This trial aims not only to compare motor outcomes but also to evaluate whether motor improvements translate into functional hand use and to explore differences in somatosensory gains between interventions. By addressing both visual and proprioceptive components of motor learning, this research may guide future clinical strategies for individualized stroke rehabilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Büyükcekmece
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Istanbul, Büyükcekmece, Turkey (Türkiye), 34500
- Istanbul University- Cerrahpasa
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34500
- Alkent 2000, 34500 Büyükçekmece/İstanbul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a ischemic/hemorrhagic stroke diagnosis through MRI and/or CT
- Volunteering to enter the study
- First ever stroke or no sequeale (mRS 0)
- Being in subacute/chronic phase of stroke (between 1st week to 1 year)
- Having a adequate sitting balance or able to maintain upright sitting position for 30 minutes
- Having a motor deficit in the hand (Brunnstrom hand motor recovery stages 1-4 )
- Having a full range of motion in hand
Exclusion Criteria:
- Severe Pain (VAS ≥ 8)
- Having a neurological or orthopedic problem in hand
- Severe spatial hemineglect (NIHSS 11th subscale> 1)
- Spasticity (mAS ≥ 2)
- Apraxia
- Visual/auditory loss that affects treatment
- Unstable Vital Signs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mirror Therapy Group
The group who receives conventional mirror therapy
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Patients in the mirror therapy group will glance at the reflection of their non-affected arm and fall into the illusion that their non-affected limb is moving.
This is supposed to assist patients regain motor deficits by reducing non-use paralysis.
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Active Comparator: Hand Robot Group
The group who receives mirror mode of a soft robotic glove
|
Mirror mode of the hand robot group will mimic the movement of the unaffected arm.
The robot will provide proprioceptive and visual feedback and make patient believe that the affected arm is moving.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl Meyer Assesment
Time Frame: 30 minutes
|
The Fugl-Meyer Assessment-Upper Extremity is a stroke-specific, performance-based impairment scale and gold-standard measure of post-stroke motor recovery that quantifies upper limb motor function using a standardized ordinal scoring system assessing reflex activity, movement control, coordination, and joint function.
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test
Time Frame: 15 minutes
|
The Action Research Arm Test (ARAT) is a performance-based assessment designed to evaluate upper limb function by measuring the ability to grasp, grip, pinch, and perform gross motor movements.
It is particularly sensitive to changes in hand and arm function after stroke and is frequently used in both clinical and research settings to monitor motor recovery.
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15 minutes
|
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Wolf Motor Function Test
Time Frame: 30 minutes
|
The Wolf Motor Function Test (WMFT) is a widely used, time-based assessment that evaluates upper extremity motor ability through a series of functional and strength-related tasks in individuals with stroke.
It measures both the time taken to complete 15 standardized activities and the quality of movement, providing objective data on motor recovery.
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30 minutes
|
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Box and Block Test
Time Frame: 5 minutes
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The Box and Block Test is a standardized, performance-based measure of gross manual dexterity that quantifies upper extremity function by counting the number of blocks transferred within 60 seconds.
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5 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ela Tarakcı, 1, Istanbul University- Cerrahapaşa
Publications and helpful links
General Publications
- Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
- Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
- Faria-Fortini I, Michaelsen SM, Cassiano JG, Teixeira-Salmela LF. Upper extremity function in stroke subjects: relationships between the international classification of functioning, disability, and health domains. J Hand Ther. 2011 Jul-Sep;24(3):257-64; quiz 265. doi: 10.1016/j.jht.2011.01.002. Epub 2011 Mar 21.
- Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
- Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
- Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.
- Arya KN, Verma R, Garg RK. Estimating the minimal clinically important difference of an upper extremity recovery measure in subacute stroke patients. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:599-610. doi: 10.1310/tsr18s01-599.
- Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.
- Baniqued PDE, Stanyer EC, Awais M, Alazmani A, Jackson AE, Mon-Williams MA, Mushtaq F, Holt RJ. Brain-computer interface robotics for hand rehabilitation after stroke: a systematic review. J Neuroeng Rehabil. 2021 Jan 23;18(1):15. doi: 10.1186/s12984-021-00820-8.
- Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICORR.2011.5975340.
- Raine, S., Meadows, L., & Lynch-Ellerington, M. (2009). Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. In Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. https://doi.org/10.1002/9781444314601
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Robot/Mirror in Stroke
- 223S419 (Other Grant/Funding Number: Scientific and Technological Research Council of Turkey)
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
product manufactured in and exported from the U.S.
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