Wearable Robotic and Virtual Reality on Hand in Stroke

Official title

Effects of Wearable Robotic and Virtual Reality-Assisted Interventions on Hand Function in Stroke Rehabilitation

Overview

Stroke is a common neurological disorder resulting from acute focal damage to the central nervous system due to vascular events such as cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage. It represents one of the leading causes of mortality and long-term disability in adults, with approximately 85 % of cases being ischemic and 15 % hemorrhagic. Among survivors, up to 70 % experience upper-limb functional loss and about 40 % remain chronically impaired, particularly in wrist and hand extension due to synergy patterns and spasticity. Rehabilitation targeting upper-limb motor recovery is therefore crucial for improving activities of daily living and social participation. Technology-assisted interventions such as wearable soft robotic gloves and virtual-reality-based motion-tracking devices have recently been introduced to enhance neuroplasticity, improve voluntary movement quality, and facilitate functional independence. This multicenter, randomized controlled clinical trial will be conducted between November 2025 and June 2026. The study will include adults aged 30-60 years with a confirmed diagnosis of post-stroke hemiplegia (ICD-10: G81) who meet the predefined inclusion criteria-including Mini-Mental State Examination \> 24, Modified Ashworth Scale \< 3, wrist extension \> 10°, Brunnstrom stage \> 3, and Fugl-Meyer Upper-Limb score \> 22-will be recruited after written informed consent. Exclusion criteria include significant neglect or visual deficits, communication disorders, peripheral nerve injury, botulinum toxin injection within the previous six months, major orthopedic surgery of the affected limb, or serious systemic comorbidities. Eligible participants will be randomly assigned to one of three groups for six weeks of therapy, three sessions per week: (1) Neurodevelopmental therapy (NDT) and wearable Soft Robotic Glove (SRG); (2) NDT and Leap Motion Controller (LMC) integrated with the Becure platform (HandROM and ErgoActive modules including LeapBall, Piano, PinchPeg, and Hold-and-Put tasks); or (3) NDT-only control group performing standard task-oriented hand exercises. Assessments will be performed at baseline and after the 18th treatment session and will include demographic data, Box-and-Block Test, Chedoke Arm and Hand Activity Inventory, surface electromyography for muscle strength, and joint-angle measurements using LMC-based Becure HandROM. The primary outcomes of this study are upper-limb functional performance and hand dexterity, while the secondary outcomes include joint range of motion, grip-pattern kinematics, and muscle strength. The findings are expected to compare and determine the effectiveness of wearable soft robotic-assisted and virtual reality-assisted interventions in post-stroke upper-limb rehabilitation, thereby guiding the evidence-based integration of advanced technologies into routine neurorehabilitation practice.

Interventions

• Device Soft Robotic Glove (SRG)
  A wearable pneumatically driven soft robotic glove assisting finger flexion-extension and various grip patterns; used with NDT three sessions per week for six weeks.
• Device Leap Motion Controller (LMC)
  A virtual-reality-based optical motion-tracking device combined with Becure HandROM/ErgoActive exercise modules; used with NDT three sessions per week for six weeks.
• Behavioral Neurodevelopmental Therapy (NDT)
  Conventional therapist-guided task-oriented upper-limb rehabilitation including resistance exercises, bottle/ball grasp-and-release, peg transfer; three sessions per week for six weeks

Primary outcome measures

• Hand Function - Chedoke Arm and Hand Activity Inventory (CAHAI) [Time frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)]
• Box-and-Block Test (BBT) [Time frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)]

Secondary outcome measures (2)

• Range-of-Motion (ROM) [Time frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)]
• Surface Electromyography (sEMG) [Time frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)]

Eligibility criteria

Inclusion criteria

• Clinical diagnosis of stroke
• Mini-Mental State Examination score > 24
• Modified Ashworth Scale score < 3
• Active wrist extension > 10°
• Brunnstrom stage > 3
• Fugl-Meyer Upper Extremity score > 22

Exclusion criteria

• Presence of significant unilateral neglect
• Presence of significant visual deficits
• Communication disorders that interfere with assessment or intervention
• Peripheral nerve injury affecting the upper limb
• Botulinum toxin injection to the affected upper limb within the previous six months
• History of major orthopedic surgery of the affected upper limb
• Serious systemic comorbidities
• History of epileptic seizures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Medipol University, Physiotherapy and Rehabilitation Department — Istanbul

Publications

• Hung CS, Hsieh YW, Wu CY, Chen YJ, Lin KC, Chen CL, Yao KG, Liu CT, Horng YS. Hybrid Rehabilitation Therapies on Upper-Limb Function and Goal Attainment in Chronic Stroke. OTJR (Thorofare N J). 2019 Apr;39(2):116-123. doi: 10.1177/1539449218825438. Epub 2019 Mar 5. PMID 30834812
• Merletti R, Gulisashvili A, Lo Conte LR. Estimation of shape characteristics of surface muscle signal spectra from time domain data. IEEE Trans Biomed Eng. 1995 Aug;42(8):769-76. doi: 10.1109/10.398637. PMID 7642190
• Schuster C, Hahn S, Ettlin T. Objectively-assessed outcome measures: a translation and cross-cultural adaptation procedure applied to the Chedoke McMaster Arm and Hand Activity Inventory (CAHAI). BMC Med Res Methodol. 2010 Nov 29;10:106. doi: 10.1186/1471-2288-10-106. PMID 21114807
• Kolbasi EN, Ersoz Huseyinsinoglu B, Erdogan HA, Cabalar M, Bulut N, Yayla V. What are the determinants of explicit and implicit motor imagery ability in stroke patients?: a controlled study. Somatosens Mot Res. 2020 Jun;37(2):84-91. doi: 10.1080/08990220.2020.1741344. Epub 2020 Mar 31. PMID 32228207
• Oh HS, Kim EJ, Kim DY, Kim SJ. Effects of Adjuvant Mental Practice on Affected Upper Limb Function Following a Stroke: Results of Three-Dimensional Motion Analysis, Fugl-Meyer Assessment of the Upper Extremity and Motor Activity Logs. Ann Rehabil Med. 2016 Jun;40(3):401-11. doi: 10.5535/arm.2016.40.3.401. Epub 2016 Jun 29. PMID 27446776
• Proietti T, Nuckols K, Grupper J, Schwerz de Lucena D, Inirio B, Porazinski K, Wagner D, Cole T, Glover C, Mendelowitz S, Herman M, Breen J, Lin D, Walsh C. Combining soft robotics and telerehabilitation for improving motor function after stroke. Wearable Technol. 2024 Jan 26;5:e1. doi: 10.1017/wtc.2023.26. eCollection 2024. PMID 38510985
• Arman N, Oktay AB, Tarakci D, Tarakci E, Akgul YS. The validity of an objective measurement method using the Leap Motion Controller for fingers wrist, and forearm ranges of motion. Hand Surg Rehabil. 2021 Sep;40(4):394-399. doi: 10.1016/j.hansur.2021.03.007. Epub 2021 Mar 26. PMID 33781957
• Villafane JH, Taveggia G, Galeri S, Bissolotti L, Mulle C, Imperio G, Valdes K, Borboni A, Negrini S. Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial. Hand (N Y). 2018 Jan;13(1):95-102. doi: 10.1177/1558944717692096. Epub 2017 Feb 16. PMID 28719996

Identifiers

NCT: NCT07287059 · E-10840098-202.3.02-4330

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗