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Post-Stroke HemiplegiaNCT07287059

Wearable Robotic and Virtual Reality on Hand in Stroke

A study testing Soft Robotic Glove (SRG) and Neurodevelopmental Therapy (NDT) in people with Post-Stroke Hemiplegia, run by Medipol University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Post-Stroke Hemiplegia
What is being tested?
Soft Robotic Glove (SRG) and Neurodevelopmental Therapy (NDT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Dec 2025to 15 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taha A Erdogan, MSc, Physiotherapist contact

+905546235525

tahayberkk@gmail.com

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

+905053855816

eatilgan@medipol.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Medipol University, Physiotherapy and Rehabilitation Department

    Istanbul, Beykoz, 34810

    Esra Atılgan, Assoc. Prof. Dr., PhD., PT, +905053855816, eatilgan@medipol.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Soft Robotic Glove (SRG), Leap Motion Controller (LMC), Neurodevelopmental Therapy (NDT)
Keywords
Stroke, Soft Robotic Glove, Leap Motion Controller, Rehabilitation, Hand Function
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • Neurodevelopmental Therapy (NDT)Behavioural

    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

Study groups in NCT07287059
Study groupRoleWhat they receive
Soft Robotic GloveExperimentalParticipants 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
Receives: Device: Soft Robotic Glove (SRG)
Leap Motion ControllerExperimentalParticipants 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.
Receives: Device: Leap Motion Controller (LMC)
Control GroupActive comparatorParticipants 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.
Receives: Behavioral: Neurodevelopmental Therapy (NDT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (2)
  1. Range-of-Motion (ROM)

    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.

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

  2. Surface Electromyography (sEMG)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start20 Dec 2025
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287059
Sponsor's protocol ID
E-10840098-202.3.02-4330
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28719996
  • 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.

    PubMed 35509444
  • 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.

    PubMed 33804247
  • 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.

    PubMed 40337193
  • 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.

    PubMed 25892679
  • 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.

    PubMed 16415682
  • 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.

    PubMed 21964750
  • 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.

    PubMed 25355838

Questions about this trial

What is this clinical trial studying?

A study testing Soft Robotic Glove (SRG) and Neurodevelopmental Therapy (NDT) in people with Post-Stroke Hemiplegia, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taha A Erdogan, MSc, Physiotherapist (+905546235525, tahayberkk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07287059, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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