| NCT ID | NCT06033027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roessingh Research and Development |
| Condition | Trauma Injury of Hand Multiple |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2024-06-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.
Eligibility 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
Contact & Investigator
Gerdienke Prange, PhD
PRINCIPAL INVESTIGATOR
Roessingh Research and Development
Frequently Asked Questions
Who can join the NCT06033027 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Trauma Injury of Hand Multiple. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06033027 currently recruiting?
Yes, NCT06033027 is actively recruiting participants. Contact the research team at g.prange@rrd.nl for enrollment information.
Where is the NCT06033027 trial being conducted?
This trial is being conducted at Enschede, Netherlands.
Who is sponsoring the NCT06033027 clinical trial?
NCT06033027 is sponsored by Roessingh Research and Development. The principal investigator is Gerdienke Prange, PhD at Roessingh Research and Development. The trial plans to enroll 5 participants.