Non-inferiority study on the cloud rehabilitation system in motor dysfunction after stroke_West China Medical Journal

Authors：

WANG Jingjing ^1,2 , WANG Tingting ² , ZHAO Kehong ² , MA Rui ³ ,  QU Yun ²

1. Department of Rehabilitation, the First Hospital of Lanzhou University, Lanzhou, Gansu 730000, P. R. China;
2. Department of Rehabilitation, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
3. Department of Rehabilitation, the Second Hospital of Lanzhou University, Lanzhou, Gansu 730000, P. R. China;

Corresponding author：

QU Yun, Email: dr_yunqu@163.com

Keywords：

Stroke; cloud rehabilitation; motor function; activity of daily living; non-inferiority study

DOI：

10.7507/1002-0179.202104288

Video：

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Objective To explore whether the effect of cloud rehabilitation system on motor dysfunction and activities of daily living (ADL) of stroke patients is not inferior to hemiplegia manual treatment. Methods This study adopted a multicenter randomized controlled trial design. A total of 118 stroke patients were enrolled from 5 hospitals in China between April 2018 and April 2019, and they were randomly divided into a trial group and a control group, with 59 patients in each group. The trial group adopted hemiplegia manual treatment (≥30 min per time, once a day) and cloud rehabilitation training (30 min per time, once a day), and the control group adopted hemiplegia manual treatment alone (≥30 min per time, twice a day). All patients received continuous treatment for 2 weeks, and followed up for 2 weeks after that. The Brunnstrom stage (BRS), IK exercise stage, and Modified Barthel Index (MBI) were used to evaluate the motor function and ADL before and 4 weeks after treatment. Results There was no significant difference in gender, age, course, hemiplegia side, source (inpatient/outpatient) or hospital grade between the two groups (P>0.05), which were comparable. Compared with those before treatment, there were significant improvements in the BRS (upper and lower extremities), IK exercise stages (upper and lower extremities), and MBI scores in both groups 4 weeks after treatment (P<0.05). The four-week improvements in motor function indicators (BRS and IK) of the trial group were not inferior to those of the control group (P<0.05), and there was no significant difference in MBI score between the two groups 4 weeks after treatment (F=1.498, P>0.05). Conclusion The cloud rehabilitation system is not inferior to hemiplegia manual treatment in improving the limb motor function or ADL of patients .

Citation： WANG Jingjing, WANG Tingting, ZHAO Kehong, MA Rui, QU Yun. Non-inferiority study on the cloud rehabilitation system in motor dysfunction after stroke. West China Medical Journal, 2023, 38(3): 424-428. doi: 10.7507/1002-0179.202104288 Copy

1.	Wang W, Jiang B, Sun H, et al. Prevalence, incidence, and mortality of stroke in China: results from a nationwide population-based survey of 480 687 adults. Circulation, 2017, 135(8): 759-771.
2.	White JH, Alston MK, Marquez JL, et al. Community-dwelling stroke survivors: function is not the whole story with quality of life. Arch Phys Med Rehabil, 2007, 88(9): 1140-1146.
3.	Redzuan NS, Engkasan JP, Mazlan M, et al. Effectiveness of a video-based therapy program at home after acute stroke: a randomized controlled trial. Arch Phys Med Rehabil, 2012, 93(12): 2177-2183.
4.	Chen J, Jin W, Dong WS, et al. Effects of home-based telesupervising rehabilitation on physical function for stroke survivors with hemiplegia: a randomized controlled trial. Am J Phys Med Rehabil, 2017, 96(3): 152-160.
5.	Lin KH, Chen CH, Chen YY, et al. Bidirectional and multi-user telerehabilitation system: clinical effect on balance, functional activity, and satisfaction in patients with chronic stroke living in long-term care facilities. Sensors (Basel), 2014, 14(7): 12451-12466.
6.	Lloréns R, Noé E, Colomer C, et al. Effectiveness, usability, and cost-benefit of a virtual reality-based telerehabilitation program for balance recovery after stroke: a randomized controlled trial. Arch Phys Med Rehabil, 2015, 96(3): 418-425.
7.	Palmcrantz S, Borg J, Sommerfeld D, et al. An interactive distance solution for stroke rehabilitation in the home setting - a feasibility study. Inform Health Soc Care, 2017, 42(3): 303-320.
8.	中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国急性缺血性脑卒中诊治指南 2018. 中华神经科杂志, 2018, 51(9): 666-682.
9.	中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国脑出血诊治指南(2014). 中华神经科杂志, 2015, 48(6): 435-444.
10.	Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther, 1966, 46(4): 357-375.
11.	Dong L, Wu JK, Bao XM. A hybrid HMM/Kalman filter for tracking hip angle in gait cycle. IEICE Trans Inf Syst, 2006, 89(7): 2319-2323.
12.	Leung SO, Chan CC, Shah S. Development of a Chinese version of the Modified Barthel Index- validity and reliability. Clin Rehabil, 2007, 21(10): 912-922.
13.	刘洪红, 都天慧, 王婷婷, 等. 远程康复设备梯度式运动功能自动评定系统在脑卒中患者中的应用. 中国医疗器械杂志, 2018, 42(2): 88-91.
14.	黄钦, 赵明. 对临床试验统计学假设检验中非劣效、等效和优效性设计的认识. 中国临床药理学杂志, 2007, 23(1): 63-67.
15.	陈卫, 徐利娜, 迭敏, 等. 差异性、等效性、非劣效性和优效性设计中的 t 检验. 成都医学院学报, 2009, 4(3): 211-213.
16.	Wolf SL, Sahu K, Bay RC, et al. The HAAPI (home arm assistance progression initiative) trial: a novel robotics delivery approach in stroke rehabilitation. Neurorehabil Neural Repair, 2015, 29(10): 958-968.
17.	Chumbler NR, Quigley P, Li X, et al. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke, 2012, 43(8): 2168-2174.
18.	van den Berg M, Crotty M, Liu E, et al. Early supported discharge by caregiver-mediated exercises and e-health support after stroke: a proof-of-concept trial. Stroke, 2016, 47(7): 1885-1892.
19.	Pedreira da Fonseca E, da Silva Ribeiro NM, Pinto EB. Therapeutic effect of virtual reality on post-stroke patients: randomized clinical trial. J Stroke Cerebrovasc Dis, 2017, 26(1): 94-100.
20.	Choi YH, Ku J, Lim H, et al. Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Restor Neurol Neurosci, 2016, 34(3): 455-463.
21.	Paul L, Wyke S, Brewster S, et al. Increasing physical activity in stroke survivors using STARFISH, an interactive mobile phone application: a pilot study. Top Stroke Rehabil, 2016, 23(3): 170-177.
22.	Chumbler NR, Li X, Quigley P, et al. A randomized controlled trial on stroke telerehabilitation: the effects on falls self-efficacy and satisfaction with care. J Telemed Telecare, 2015, 21(3): 139-143.
23.	Benvenuti F, Stuart M, Cappena V, et al. Community-based exercise for upper limb paresis: a controlled trial with telerehabilitation. Neurorehabil Neural Repair, 2014, 28(7): 611-620.
24.	Chaiyawat P, Kulkantrakorn K. Effectiveness of home rehabilitation program for ischemic stroke upon disability and quality of life: a randomized controlled trial. Clin Neurol Neurosurg, 2012, 114(7): 866-870.

1. Wang W, Jiang B, Sun H, et al. Prevalence, incidence, and mortality of stroke in China: results from a nationwide population-based survey of 480 687 adults. Circulation, 2017, 135(8): 759-771.
2. White JH, Alston MK, Marquez JL, et al. Community-dwelling stroke survivors: function is not the whole story with quality of life. Arch Phys Med Rehabil, 2007, 88(9): 1140-1146.
3. Redzuan NS, Engkasan JP, Mazlan M, et al. Effectiveness of a video-based therapy program at home after acute stroke: a randomized controlled trial. Arch Phys Med Rehabil, 2012, 93(12): 2177-2183.
4. Chen J, Jin W, Dong WS, et al. Effects of home-based telesupervising rehabilitation on physical function for stroke survivors with hemiplegia: a randomized controlled trial. Am J Phys Med Rehabil, 2017, 96(3): 152-160.
5. Lin KH, Chen CH, Chen YY, et al. Bidirectional and multi-user telerehabilitation system: clinical effect on balance, functional activity, and satisfaction in patients with chronic stroke living in long-term care facilities. Sensors (Basel), 2014, 14(7): 12451-12466.
6. Lloréns R, Noé E, Colomer C, et al. Effectiveness, usability, and cost-benefit of a virtual reality-based telerehabilitation program for balance recovery after stroke: a randomized controlled trial. Arch Phys Med Rehabil, 2015, 96(3): 418-425.
7. Palmcrantz S, Borg J, Sommerfeld D, et al. An interactive distance solution for stroke rehabilitation in the home setting - a feasibility study. Inform Health Soc Care, 2017, 42(3): 303-320.
8. 中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国急性缺血性脑卒中诊治指南 2018. 中华神经科杂志, 2018, 51(9): 666-682.
9. 中华医学会神经病学分会, 中华医学会神经病学分会脑血管病学组. 中国脑出血诊治指南(2014). 中华神经科杂志, 2015, 48(6): 435-444.
10. Brunnstrom S. Motor testing procedures in hemiplegia: based on sequential recovery stages. Phys Ther, 1966, 46(4): 357-375.
11. Dong L, Wu JK, Bao XM. A hybrid HMM/Kalman filter for tracking hip angle in gait cycle. IEICE Trans Inf Syst, 2006, 89(7): 2319-2323.
12. Leung SO, Chan CC, Shah S. Development of a Chinese version of the Modified Barthel Index- validity and reliability. Clin Rehabil, 2007, 21(10): 912-922.
13. 刘洪红, 都天慧, 王婷婷, 等. 远程康复设备梯度式运动功能自动评定系统在脑卒中患者中的应用. 中国医疗器械杂志, 2018, 42(2): 88-91.
14. 黄钦, 赵明. 对临床试验统计学假设检验中非劣效、等效和优效性设计的认识. 中国临床药理学杂志, 2007, 23(1): 63-67.
15. 陈卫, 徐利娜, 迭敏, 等. 差异性、等效性、非劣效性和优效性设计中的 t 检验. 成都医学院学报, 2009, 4(3): 211-213.
16. Wolf SL, Sahu K, Bay RC, et al. The HAAPI (home arm assistance progression initiative) trial: a novel robotics delivery approach in stroke rehabilitation. Neurorehabil Neural Repair, 2015, 29(10): 958-968.
17. Chumbler NR, Quigley P, Li X, et al. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke, 2012, 43(8): 2168-2174.
18. van den Berg M, Crotty M, Liu E, et al. Early supported discharge by caregiver-mediated exercises and e-health support after stroke: a proof-of-concept trial. Stroke, 2016, 47(7): 1885-1892.
19. Pedreira da Fonseca E, da Silva Ribeiro NM, Pinto EB. Therapeutic effect of virtual reality on post-stroke patients: randomized clinical trial. J Stroke Cerebrovasc Dis, 2017, 26(1): 94-100.
20. Choi YH, Ku J, Lim H, et al. Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Restor Neurol Neurosci, 2016, 34(3): 455-463.
21. Paul L, Wyke S, Brewster S, et al. Increasing physical activity in stroke survivors using STARFISH, an interactive mobile phone application: a pilot study. Top Stroke Rehabil, 2016, 23(3): 170-177.
22. Chumbler NR, Li X, Quigley P, et al. A randomized controlled trial on stroke telerehabilitation: the effects on falls self-efficacy and satisfaction with care. J Telemed Telecare, 2015, 21(3): 139-143.
23. Benvenuti F, Stuart M, Cappena V, et al. Community-based exercise for upper limb paresis: a controlled trial with telerehabilitation. Neurorehabil Neural Repair, 2014, 28(7): 611-620.
24. Chaiyawat P, Kulkantrakorn K. Effectiveness of home rehabilitation program for ischemic stroke upon disability and quality of life: a randomized controlled trial. Clin Neurol Neurosurg, 2012, 114(7): 866-870.

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