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| ID | Type | Description | Link |
|---|---|---|---|
| 223S419 | Other Grant/Funding Number | Scientific and Technological Research Council of Turkey |
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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
| Istanbul University - Cerrahpasa | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirror Therapy Group | Active Comparator | The group who receives conventional mirror therapy |
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| Hand Robot Group | Active Comparator | The group who receives mirror mode of a soft robotic glove |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Robot Mirror Mode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assesment | 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. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | 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. | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ela Tarakcı, 1 | Istanbul University- Cerrahapaşa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University- Cerrahpasa | Istanbul | Büyükcekmece | 34500 | Turkey (Türkiye) | ||
| Alkent 2000, 34500 Büyükçekmece/İstanbul |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22120029 | Background | 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. | |
| 33485365 | Background | 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. |
| Label | URL |
|---|---|
| hand robot that will be used in this research | View source |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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Due to the nature of the intervention, participant and therapist blinding was not feasible, and outcome assessments were performed without masking.
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| Therapy Mirror | Device | 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. |
|
| Wolf Motor Function Test | 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. | 30 minutes |
| Box and Block Test | 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. | 5 minutes |
| Istanbul |
| Istanbul |
| 34500 |
| Turkey (Türkiye) |
| 32592282 | Background | 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. |
| 21420279 | Background | 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. |
| 22275545 | Background | 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. |
| 7811170 | Background | 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. |
| 12907818 | Background | 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. |
| 30175845 | Background | 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. |
| 8172497 | Background | 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. |
| Background | 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 |
| 29993119 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |