Wearable Robotic and Virtual Reality on Hand in Stroke

January 27, 2026 updated by: Taha Ayberk Erdoğan, Medipol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Taha A Erdogan, MSc, Physiotherapist
  • Phone Number: +905546235525
  • Email: tahayberkk@gmail.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Beykoz
      • Istanbul, Beykoz, Turkey (Türkiye), 34810
        • Recruiting
        • Istanbul Medipol University, Physiotherapy and Rehabilitation Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soft Robotic Glove
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)
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.
Experimental: Leap Motion Controller
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)
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.
Active Comparator: Control Group
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range-of-Motion (ROM)
Time Frame: Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)
Joint kinematics of the wrist and fingers are measured using the Leap Motion Controller integrated with the Becure HandROM system. The device records angular values of flexion/extension, abduction/adduction, and radial/ulnar deviation during grasp patterns. Greater angular range indicates improved active joint mobility and motor performance.
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)
Surface electromyography (sEMG) records electrical activity of selected upper-limb muscles during voluntary movement. Non-invasive surface electrodes are placed on the wrist and finger extensor/flexor groups to evaluate muscle activation amplitude and pattern. Increased amplitude reflects improved voluntary muscle recruitment and motor control.
Baseline (pre-treatment, week 0) and after 6 weeks of intervention (post-treatment, week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-202.3.02-4330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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