Wearable robotic glove plus virtual reality to help hand recovery after stroke
Effects of Wearable Robotic and Virtual Reality-Assisted Interventions on Hand Function in Stroke Rehabilitation
NA · Medipol University · NCT07287059
This trial will test whether using a soft robotic glove together with a Leap Motion virtual-reality controller improves hand movement in adults with one-sided weakness after stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Medipol University (other) |
| Locations | 1 site (Istanbul, Beykoz) |
| Trial ID | NCT07287059 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized controlled trial comparing technology-assisted therapy using a soft robotic glove combined with a Leap Motion motion-tracking controller versus conventional neurodevelopmental therapy for upper-limb rehabilitation. Eligible participants are adults after stroke with preserved cognition and some active wrist extension who meet motor-function thresholds. Participants will be randomly assigned to receive the robotic/virtual-reality intervention or standard therapy and outcomes will focus on hand and upper-extremity motor function. The trial aims to increase voluntary movement quality and functional use of the affected hand through increased repetitive, task-oriented practice supported by wearable and motion-tracking technology.
Who should consider this trial
Good fit: Adults with post-stroke hemiplegia who can follow instructions (MMSE > 24), have some active wrist extension (> 10°), moderate motor recovery (Brunnstrom > 3, Fugl-Meyer UE > 22), and no severe spasticity (Modified Ashworth Scale < 3) are ideal candidates.
Not a fit: People with severe unilateral neglect, major visual or communication deficits, peripheral nerve injury to the arm, recent botulinum toxin to the affected limb, history of major upper-limb surgery, uncontrolled medical comorbidities, or a history of seizures are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could improve hand movement and daily-function independence for people with post-stroke hemiplegia.
How similar studies have performed: Prior small trials and pilot studies of soft robotic gloves and virtual-reality motion tracking have reported promising gains in hand movement and practice intensity, but larger randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul, Beykoz
- Istanbul Medipol University, Physiotherapy and Rehabilitation Department — Istanbul, Beykoz, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Taha A Erdogan, MSc, Physiotherapist
- Email: tahayberkk@gmail.com
- Phone: +905546235525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Stroke Hemiplegia, Stroke, Soft Robotic Glove, Leap Motion Controller, Rehabilitation, Hand Function