Soft-robotic glove to support hand and arm use
Influence of Assistive Soft-robotic Glove Use on Actual Arm Use in Daily Life
This study will try a wearable soft-robotic glove to help adults with hand problems from trauma or neurological conditions use their affected hand and arm more during daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Roessingh Research and Development Academic / other |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT06033027 on ClinicalTrials.gov |
What this trial studies
This single-case experimental design enrolls 3–5 adults with chronic hand limitations to use a supportive soft-robotic glove at home for six weeks while performing personally relevant daily activities. Participants will wear activity meters on both wrists during the day and complete supervised hand squeeze tests by video call, alongside repeated questionnaires about perceived hand function and well-being. Measurements are collected for several weeks before, during, and after glove use, totaling at least 15 assessment points over 12–14 weeks. The protocol builds on earlier work with prior versions of the device and focuses on real-world arm and hand use rather than only lab-based measures.
Who should consider this trial
Good fit: Ideal candidates are adults (18–90) with chronic, stable hand limitations from trauma-related injury or neurologic disorder who can activate and relax the glove, have sufficient cognition and vision, live independently, and can provide informed consent.
Not a fit: Patients with severe sensory loss, severe acute hand pain, open hand wounds, major contractures, severe spasticity, or other comorbidities that limit arm/hand function are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the glove could increase everyday hand and arm use and make common daily tasks easier for people with chronic hand impairments.
How similar studies have performed: Earlier small studies of previous versions of this glove have shown promising results for grip support, so the approach has preliminary support but remains limited in scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 90 years * Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder * Being in a chronic/stable phase of disease as judged by their physician * Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object * Ability to relax an active grip * Sufficient cognitive status to understand two-step instructions * Having (corrected to) normal vision * Able to provide written informed consent * Living independently Exclusion Criteria: * Severe sensory problems of the most-affected hand * Severe acute pain of the most-affected hand * Wounds on the hands that can provide a problem when using the glove * Severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably * Co-morbidities limiting functional use/performance of the arms and/or hands * Severe spasticity of the hand (≥2 points on Ashworth Scale) * Severe proximal weakness (MRC shoulder elevation\<4) * Used the Carbonhand system in the past 3 months * Participation in other studies that can affect functional performance of the arm/hand * Receiving arm-/hand function therapy during the course of the study * Insufficient digital literacy to conduct video calls * Insufficient knowledge of the Dutch or English language to understand the purpose or methods of the study
Where this trial is running
Enschede, Overijssel
- Roessingh Research and Development — Enschede, Overijssel, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gerdienke Prange, PhD — Roessingh Research and Development
- Study coordinator: Gerdienke Prange, PhD
- Email: g.prange@rrd.nl
- Phone: +31 (0)88 087 5777
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.