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This clinical trial aims to compare the effectiveness of Robotic versus conventional mirror therapy among post-stroke patients. The main questions it aims to answer are:
Research design This research is an experimental study with a randomized controlled trial research design.
Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation centre in Makassar
Procedure
Time frame the procedure will be conducted in parallel three times per week for a total of six weeks
Outcomes
Covariates and potential confounders
Procedure The data collected is primary data obtained in accordance with the inclusion criteria.
Samples who are willing to become research subjects will undergo interviews, physical examinations, FMA-UE-Hand Motor Domain and NHPT examinations. The interview questionnaire in this study will contain a list of patient identities including name, age, marital status, address, educational history, employment history, history of stroke, cognitive examination (MMSE), and self-reported visual ability.
The FMA-UE-Hand Motor Domain scoring system is used to evaluate upper extremity motor function in patients with neurological disorders, such as stroke. The scoring system ranges from 0-14, with higher scores indicating better motor function. The FMA-UE-Hand Motor domain assessment system is broken down into several subscales, namely Mass Flexion and Extension movements, followed by functional movements of grasping (Grasp), including Hook Grasp, Thumb Adduction, Pincer Grasp, Cylinder Grasp, and Spherical Grasp. The assessment will get a score of 0 = None or no movement, 1 = Partial or limited movement, and 2 = Full or perfect movement.
The NHPT assessment consists of a square board with 9 pegs. At one end of the board, there is a hole for the peg, and at the other end, there is a shallow round plate for holding the peg. NHPT is performed by having the patient take pegs from a container, one at a time, and place them into the holes in a board, as quickly as possible. The patient must then remove the pegs from the holes, one at a time, and reinsert them into the housing. To practice and register initial scores, the test must be started with the unaffected upper limb. The board should be placed in the centre of the patient's body with the housing holding the pegs oriented toward the hand being tested. Only the hand being evaluated should perform the test. The non-evaluated hand is allowed to grip the edge of the board to provide stability. Patients are scored based on the time required to complete the test activity, recorded in seconds. The stopwatch must start from the moment the participant touches the first peg until the last peg touches the container. This assessment requires a board, of wood or plastic, with 9 holes (10 mm diameter, 15 mm depth), spaced 32 mm or 50 mm apart and a stopwatch.
Sample Size Based on previous research, the value of the standard deviation of the selected outcome = 11.5 and the value of x1-x2 = 9.1 (Lin, 2020). The Zα value = 1.96 with a confidence interval of 95% and the Zβ value = 0.84 with a power of 80%, two arms and a dropout rate of 30% at least 40 participants should be recruited. A consecutive sampling will be applied and allocated randomly using the simple randomization technique.
Proposed Statistical Analysis Data on the effect of robotic mirror therapy compared to conventional mirror therapy will be assessed using the independent t-test. Data from the FMA-UE and NHPT assessments before and after the intervention will be analyzed using the paired t-test. Next, the relationship between the FMA-UE and NHPT values will be assessed using the Pearson correlation test (normally distributed data) or the Spearman test (data not normally distributed) to determine how big the correlation is between these variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Mirror Therapy | Experimental | Serial training with the help of exoskeletal robot therapy |
|
| Conventional Mirror Therapy | Active Comparator | Serial training with the help of physical therapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYREBO | Procedure | Serial ADL training of upper extremities with robotic aid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FMA-UE Score | a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement | changes of FMA-UE score from pre-intervention to six weeks after intervention |
| NHPT value | an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively. | changes of NHPT values from pre-intervention to six weeks after intervention |
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Inclusion criteria:
Exclusion criteria:
Dropout criteria:
Patients were excluded from the study if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Kurniawan, MD | Contact | +6281319912162 | stvn.aupp@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Steven Kurniawan, MD | Hasanuddin University | Principal Investigator |
| Nuralam Sam, MD. Ph.D | Hasanuddin University | Principal Investigator |
| Husnul Mubarak, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerebellum Clinic | Makassar | South Sulawesi | 90231 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27583794 | Background | Beom J, Koh S, Nam HS, Kim W, Kim Y, Seo HG, Oh BM, Chung SG, Kim S. Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms. J Vis Exp. 2016 Aug 15;(114):54521. doi: 10.3791/54521. | |
| 3809245 | Background | Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206. |
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To protect the confidentiality, should the data need to share, any de-identified data will be shared for peer-review
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The intervention group will be the robotic and the active comparator will be the conventional mirror therapy exercise group
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| Conventional Mirror Method |
| Procedure |
Serial ADL training of upper extremities assisted by physical therapist |
|
| Hasanuddin University |
| Principal Investigator |
| Yose Waluyo, MD. PhD | Hasanuddin University | Principal Investigator |
| Andi A Zainuddin, MD.Phd | Hasanuddin University | Principal Investigator |
| Andi A Mochtar, Dr. Eng | Hasanuddin University | Principal Investigator |
| Hasanuddin University, Faculty of Medicine | Makassar | South Sulawesi | 90245 | Indonesia |
|
| Wahidin Sudirohusodo General Hospital | Makassar | South Sulawesi | 90245 | Indonesia |
|
| Background | Chowdhury, Z., 2018. Effectiveness of Mirror Therapy on hand function improvement among patients with chronic stroke. IOSR Journal of Nursing and Health Science (IOSR-JNHS) e-ISSN: 2320-1959.p- ISSN: 2320-1940 Volume 4, Issue 6 Ver. V (Nov. - Dec. 2015), PP 01-04 |
| 33304304 | Background | Hijikata N, Kawakami M, Ishii R, Tsuzuki K, Nakamura T, Okuyama K, Liu M. Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment. Front Neurol. 2020 Nov 16;11:577855. doi: 10.3389/fneur.2020.577855. eCollection 2020. |
| 22469877 | Background | Lee MM, Cho HY, Song CH. The mirror therapy program enhances upper-limb motor recovery and motor function in acute stroke patients. Am J Phys Med Rehabil. 2012 Aug;91(8):689-96, quiz 697-700. doi: 10.1097/PHM.0b013e31824fa86d. |
| 34626693 | Background | Nogueira NGHM, Parma JO, Leao SESA, Sales IS, Macedo LC, Galvao ACDR, de Oliveira DC, Murca TM, Fernandes LA, Junqueira C, Lage GM, Ferreira BP. Mirror therapy in upper limb motor recovery and activities of daily living, and its neural correlates in stroke individuals: A systematic review and meta-analysis. Brain Res Bull. 2021 Dec;177:217-238. doi: 10.1016/j.brainresbull.2021.10.003. Epub 2021 Oct 7. |
| 21326041 | Background | Rothgangel AS, Braun SM, Beurskens AJ, Seitz RJ, Wade DT. The clinical aspects of mirror therapy in rehabilitation: a systematic review of the literature. Int J Rehabil Res. 2011 Mar;34(1):1-13. doi: 10.1097/MRR.0b013e3283441e98. |
| 35848045 | Background | Schrader M, Sterr A, Kettlitz R, Wohlmeiner A, Buschfort R, Dohle C, Bamborschke S. The effect of mirror therapy can be improved by simultaneous robotic assistance. Restor Neurol Neurosci. 2022;40(3):185-194. doi: 10.3233/RNN-221263. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |