Stroke Clinical Trial
Official title:
Comparison Of Robotic And Conventional Mirror Therapy On Hand Motoric Recovery And Functional Outcomes For Rehabilitation Of Post-Stroke Patients
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: - Effectiveness of both interventions in hand motoric recovery across time - Effectiveness of both interventions in functional outcomes across time - Clinical outcome difference between both interventions Participants will be allocated into either a robotic group as the main intervention or a mirror therapy group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | March 30, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion criteria: 1. Patients aged 20 - 85 years. 2. Non-haemorrhagic stroke/infarction with onset more than 3 months from the onset of the attack. 3. Patients with unilateral upper limb hemiparesis. 4. Modified Ashworth Scale (MAS) on fingers and hands <3 5. The patient has not undergone mirror therapy treatment before. 6. Patients who are able to understand informed consent to participate in research. 7. The patient had a Radiology imaging of the head at the time of stroke onset. Exclusion criteria: 1. Patients with severe spasticity or contractures of the upper extremities. 2. Patients with infarction/bleeding with extensive lesions covering 2 hemispheres. 3. The patient has severe cognitive impairment that will interfere with the research objectives (MMSE score >24). 4. Patients post Digital Subtraction Angiography (DSA) procedures in the last 2 months. 5. Patients with a history of seizures or epilepsy. 6. Patients with visual field deficits or severe visual impairment. 7. Patients who are unable to sit upright without assistance. 8. Other uncontrolled medical conditions (musculoskeletal, neuromuscular, cardiorespiratory) that may interfere with the ability to exercise. Dropout criteria: Patients were excluded from the study if: 1. Participant dies. 2. Participants take part in the exercise <3 times for 2 consecutive weeks. 3. The participant refuses to continue the training session. 4. Participants experience hemodynamic disorders during the training program phase. 5. Participants experience neurological disorders during the training program phase. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cerebellum Clinic | Makassar | South Sulawesi |
Indonesia | Hasanuddin University, Faculty of Medicine | Makassar | South Sulawesi |
Indonesia | Wahidin Sudirohusodo General Hospital | Makassar | South Sulawesi |
Lead Sponsor | Collaborator |
---|---|
Hasanuddin University |
Indonesia,
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. — View Citation
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. — View Citation
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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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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