Wearable soft-robotic glove to assist hand function
Changes in Movement Profile Related to Use of a Soft-robotic Glove During High-demand Tasks
This study is testing a soft-robotic glove to see if it can help people with muscle and nerve issues improve their hand function and make everyday tasks easier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Roessingh Research and Development Academic / other |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT05318638 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a soft-robotic glove designed to support hand grip and improve hand function in individuals with neuromuscular diseases or age-related decline. Participants will engage in activities of daily living (ADL) while using the glove, allowing researchers to analyze the effects on movement patterns and any associated pain or discomfort. The study aims to determine whether the glove can enhance performance in strenuous tasks compared to not using the device. Previous findings suggest potential therapeutic benefits from prolonged use, although some participants reported initial discomfort.
Who should consider this trial
Good fit: Ideal candidates include frail elderly individuals aged 65-90 or neuromuscular patients aged 18-80 with reduced hand function.
Not a fit: Patients currently receiving treatment for conditions affecting hand function may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the ability of patients to perform daily activities independently.
How similar studies have performed: Previous studies using similar soft-robotic approaches have shown promising results, indicating potential for therapeutic benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Frail elderly with reduced hand function: * Age between 65 and 90 years * Experience difficulties in performing ADL due to a decline in hand function * Able to make a pinch grip between thumb and middle or ring finger * Sufficient cognitive status to understand two-step instructions * Having (corrected to) normal vision * Able to provide written informed consent * Neuromuscular patients: * Age between 18 and 80 years * Experience difficulties in performing ADL due to a decline in hand function that can be attributed to a diagnosed neuromuscular disease * Being in a chronic and stable phase of disease * Able to make a pinch grip between thumb and middle or ring finger * Sufficient cognitive status to understand two-step instructions * Having (corrected to) normal vision * Able to provide written informed consent Exclusion Criteria: * Frail elderly with reduced hand function: * Currently receiving treatment for a disease affecting arm/hand function * Used the CarbonHand system in the past 3 months * 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 * Severe spasticity of the hand (≥2 points on Ashworth Scale) * Insufficient knowledge of the Dutch language to understand the purpose or methods of the study * Neuromuscular patients: * Severe sensory problems of the most-affected hand
Where this trial is running
Enschede, Overijssel
- Roessingh Research and Development — Enschede, Overijssel, Netherlands (Recruiting)
Study contacts
- Principal investigator: G. Prange, PhD — Roessingh Research and Development
- Study coordinator: G. Prange, PhD
- Email: g.prange@rrd.nl
- Phone: +31 88875777
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.