Wearable Robotic and Virtual Reality on Hand in Stroke

NCT07287059 | Recruiting

• 1 other identifier: E-10840098-202.3.02-4330
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Stroke Hemiplegia

Keywords

Stroke; Soft Robotic Glove; Leap Motion Controller; Rehabilitation; Hand Function

Outcome Measures

Primary Outcomes (2)

• Hand Function - Chedoke Arm and Hand Activity Inventory (CAHAI)

  The Chedoke Arm and Hand Activity Inventory (CAHAI) evaluates functional bilateral task performance in individuals with post-stroke hemiplegia. It consists of 9 functional tasks scored on a 7-point scale (1 = total assistance, 7 = complete independence). Higher scores indicate better upper-limb functional performance and independence in daily activities.

  Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)

• Box-and-Block Test (BBT)

  The Box and Block Test (BBT) measures unilateral gross manual dexterity. Participants move as many wooden blocks as possible from one compartment of a box to another in 60 seconds. The total number of transferred blocks is recorded; higher scores indicate better hand dexterity and motor coordination.

  Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)

Secondary Outcomes (2)

• Range-of-Motion (ROM)

  Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)

• Surface Electromyography (sEMG)

  Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)

Study Arms (3)

Soft Robotic Glove

EXPERIMENTAL

Participants receive conventional Neurodevelopmental Therapy (NDT) combined with a wearable soft robotic glove (SRG) performing standard grip, tripod grip, palmar grip, and 1st-5th finger opposition tasks, 3 sessions/week for 6 weeks

Device: Soft Robotic Glove (SRG)

Leap Motion Controller

EXPERIMENTAL

Participants receive conventional NDT combined with Leap Motion Controller integrated with the Becure HandROM and ErgoActive modules, performing LeapBall (wrist flexion/extension, abduction/adduction), Piano (finger flexion/extension), PinchPeg (precision pinch), and Hold-and-Put (palmar grasp-release) exercises, 3 sessions/week for 6 weeks.

Device: Leap Motion Controller (LMC)

Control Group

ACTIVE COMPARATOR

Participants receive NDT alone, supplemented with standard task-oriented hand exercises such as resisted wrist/hand movements, bottle grasp-release, peg transfer, and ball grasp-release activities, 3 sessions/week for 6 weeks.

Behavioral: Neurodevelopmental Therapy (NDT)

Interventions

Soft Robotic Glove (SRG) DEVICE

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.

Soft Robotic Glove

Leap Motion Controller (LMC) DEVICE

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.

Leap Motion Controller

Neurodevelopmental Therapy (NDT) BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University, Physiotherapy and Rehabilitation Department

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

Related Publications (16)

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• 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.

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• 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.

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• 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.

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• Thimabut W, Terachinda P, Kitisomprayoonkul W. Effectiveness of a Soft Robotic Glove to Assist Hand Function in Stroke Patients: A Cross-Sectional Pilot Study. Rehabil Res Pract. 2022 Apr 25;2022:3738219. doi: 10.1155/2022/3738219. eCollection 2022.

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• Cortes-Perez I, Zagalaz-Anula N, Montoro-Cardenas D, Lomas-Vega R, Obrero-Gaitan E, Osuna-Perez MC. Leap Motion Controller Video Game-Based Therapy for Upper Extremity Motor Recovery in Patients with Central Nervous System Diseases. A Systematic Review with Meta-Analysis. Sensors (Basel). 2021 Mar 15;21(6):2065. doi: 10.3390/s21062065.

  PMID: 33804247 BACKGROUND

• Crow J, Smith A. National Clinical Guideline for Stroke for the United Kingdom and Ireland: Part I - An overview of the updated recommendations. Br J Occup Ther. 2023 Oct;86(10):661-664. doi: 10.1177/03080226231188020. Epub 2023 Jul 31. No abstract available.

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• AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.

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• Krakauer JW. Motor learning: its relevance to stroke recovery and neurorehabilitation. Curr Opin Neurol. 2006 Feb;19(1):84-90. doi: 10.1097/01.wco.0000200544.29915.cc.

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• Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.

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• Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Dec;45(12):3754-832. doi: 10.1161/STR.0000000000000046. Epub 2014 Oct 28.

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• Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

  PMID: 23652265 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Taha A Erdogan, MSc, Physiotherapist

CONTACT

+905546235525; tahayberkk@gmail.com

Esra Atılgan, Assoc. Prof. Dr., PhD, PT

CONTACT

+905053855816; eatilgan@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist (MSc) - Principal Investigator

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 16, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)