Post-Stroke Hemiplegia
Conditions
Keywords
Stroke, Soft Robotic Glove, Leap Motion Controller, Rehabilitation, Hand Function
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.
Interventions
DEVICESoft 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.
DEVICELeap 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.
BEHAVIORALNeurodevelopmental 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
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Function - Chedoke Arm and Hand Activity Inventory (CAHAI) | 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. |
| Box-and-Block Test (BBT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range-of-Motion (ROM) | 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. |
| Surface Electromyography (sEMG) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTaha A Erdogan, MSc, Physiotherapist
CONTACTEsra Atılgan, Assoc. Prof. Dr., PhD, PT
Outcome results
None listed