Soft-robotic glove to support hand and arm use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ask Questions About Clinical Trials: A Tool to Help Patients Discuss Trials

  This study tests a patient-friendly brochure called the ASQ-CT to see if it helps adults with cancer, heart disease, or neurologic conditions talk with their providers about clinical trials.

  Recruiting at 8 sites Barbara Ann Karmanos Cancer Institute · Bay City, Michigan and 7 other locations · NCT07343297

• Postoperative breathing problems after (adeno)tonsillectomy in children with sleep apnea

  See how common breathing problems are after (adeno)tonsillectomy in children with obstructive sleep apnea and which factors raise the risk.

  Recruiting University Hospital, Antwerp · Edegem, Antwerp and 1 other locations · NCT07305168

• Registry and natural history of epilepsy-dyskinesia syndromes

  This registry will collect health data and biological samples from people of all ages who have a genetic diagnosis of epilepsy-dyskinesia syndromes to see how their genes relate to their movement and seizure symptoms over time.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT06967727

• Investigating the health effects of harmful algal blooms

  This study is trying to see how exposure to toxins from harmful algal blooms affects people's health, especially their brain and immune system, by monitoring participants over time.

  Recruiting Roskamp Institute Inc. · Sarasota, Florida · NCT06883227

• Using a serious game to help children with neurological disorders improve upper limb function

  This study is testing a fun game designed to help children aged 4 to 17 with neurological disorders improve their hand movements and overall arm function during rehabilitation.

  Recruiting at 2 sites Fondation Ellen Poidatz · Antony and 1 other locations · NCT06866730

• Combined whole-brain MRI to predict recovery after cardiac arrest

  This study tests whether personalized whole-brain MRI connectivity maps can better predict six-month neurological recovery in adults who remain unconscious after cardiac arrest compared with standard predictors.

  Recruiting University Hospital, Toulouse · Toulouse · NCT06617377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.