{"title":"Effects of a wearable hand orthosis on upper and lower limb motor recovery in stroke patients: a randomized controlled trial.","authors":"Lijuan Xu, Jie Zhang, Qiang Liu, Yefan Cao, Nazhakaiti Aizezi, Jing Tian, Cheng Wu, Liyu Fang, Liyi Chen, Yanzheng Zhang, Xueming Pang, Yanli Lin, Jingxin Wang, Hewei Wang","doi":"10.3389/fbioe.2025.1600706","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Orthoses have shown potential in addressing upper limb spasticity in stroke survivors; however, their influence on motor recovery remains controversial. This study aimed to examine the effects of a wearable hand orthosis on spasticity, motor recovery of both upper and lower limbs, balance, and activities of daily living in stroke.</p><p><strong>Design: </strong>Randomized controlled trial.</p><p><strong>Setting: </strong>Inpatient rehabilitation department.</p><p><strong>Participants: </strong>Fifty-one stroke survivors with hemiplegia were randomly assigned to either an experimental group (n = 26) or a control group (n = 25).</p><p><strong>Interventions: </strong>Both groups underwent a 4-week conventional rehabilitation program. Participants in the experimental group engaged in a self-directed training program utilizing a wearable hand orthosis for 5 h daily, whereas the control group followed the identical regimen without the use of the orthosis.</p><p><strong>Outcome measures: </strong>Modified Ashworth Scale (MAS) for spasticity, Fugl-Meyer Assessment for upper and lower extremities (FMA-UE & FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI).</p><p><strong>Results: </strong>The experimental group showed greater improvements in FMA-UE (difference = 4.37, P = 0.022), BBS (difference = 12.37, P < 0.001), and BI (difference = 17.65, P < 0.001) compared to the control group. No significant differences were found in MAS (P = 0.654) or FMA-LE (P = 0.495). A stepwise multiple linear regression analysis revealed that improvement in FMA-UE was a significant predictor of BBS recovery in the experimental group (<i>r</i> <sup>2</sup> = 0.207, P = 0.022).</p><p><strong>Conclusion: </strong>The use of a wearable hand orthosis in self-directed training significantly improved upper limb motor recovery, balance, and ADL abilities in stroke survivors. The observed correlation between upper limb recovery and balance improvement indicates the potential of this orthosis to facilitate comprehensive rehabilitation.</p>","PeriodicalId":12444,"journal":{"name":"Frontiers in Bioengineering and Biotechnology","volume":"13 ","pages":"1600706"},"PeriodicalIF":4.3000,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12162502/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Bioengineering and Biotechnology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.3389/fbioe.2025.1600706","RegionNum":3,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: Orthoses have shown potential in addressing upper limb spasticity in stroke survivors; however, their influence on motor recovery remains controversial. This study aimed to examine the effects of a wearable hand orthosis on spasticity, motor recovery of both upper and lower limbs, balance, and activities of daily living in stroke.
Design: Randomized controlled trial.
Setting: Inpatient rehabilitation department.
Participants: Fifty-one stroke survivors with hemiplegia were randomly assigned to either an experimental group (n = 26) or a control group (n = 25).
Interventions: Both groups underwent a 4-week conventional rehabilitation program. Participants in the experimental group engaged in a self-directed training program utilizing a wearable hand orthosis for 5 h daily, whereas the control group followed the identical regimen without the use of the orthosis.
Outcome measures: Modified Ashworth Scale (MAS) for spasticity, Fugl-Meyer Assessment for upper and lower extremities (FMA-UE & FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI).
Results: The experimental group showed greater improvements in FMA-UE (difference = 4.37, P = 0.022), BBS (difference = 12.37, P < 0.001), and BI (difference = 17.65, P < 0.001) compared to the control group. No significant differences were found in MAS (P = 0.654) or FMA-LE (P = 0.495). A stepwise multiple linear regression analysis revealed that improvement in FMA-UE was a significant predictor of BBS recovery in the experimental group (r2 = 0.207, P = 0.022).
Conclusion: The use of a wearable hand orthosis in self-directed training significantly improved upper limb motor recovery, balance, and ADL abilities in stroke survivors. The observed correlation between upper limb recovery and balance improvement indicates the potential of this orthosis to facilitate comprehensive rehabilitation.
期刊介绍：
The translation of new discoveries in medicine to clinical routine has never been easy. During the second half of the last century, thanks to the progress in chemistry, biochemistry and pharmacology, we have seen the development and the application of a large number of drugs and devices aimed at the treatment of symptoms, blocking unwanted pathways and, in the case of infectious diseases, fighting the micro-organisms responsible. However, we are facing, today, a dramatic change in the therapeutic approach to pathologies and diseases. Indeed, the challenge of the present and the next decade is to fully restore the physiological status of the diseased organism and to completely regenerate tissue and organs when they are so seriously affected that treatments cannot be limited to the repression of symptoms or to the repair of damage. This is being made possible thanks to the major developments made in basic cell and molecular biology, including stem cell science, growth factor delivery, gene isolation and transfection, the advances in bioengineering and nanotechnology, including development of new biomaterials, biofabrication technologies and use of bioreactors, and the big improvements in diagnostic tools and imaging of cells, tissues and organs.
In today`s world, an enhancement of communication between multidisciplinary experts, together with the promotion of joint projects and close collaborations among scientists, engineers, industry people, regulatory agencies and physicians are absolute requirements for the success of any attempt to develop and clinically apply a new biological therapy or an innovative device involving the collective use of biomaterials, cells and/or bioactive molecules. “Frontiers in Bioengineering and Biotechnology” aspires to be a forum for all people involved in the process by bridging the gap too often existing between a discovery in the basic sciences and its clinical application.
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