Actively Recruiting
Arm Use With Soft-robotic Glove
Led by Roessingh Research and Development · Updated on 2026-05-07
5
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
R
Roessingh Research and Development
Lead Sponsor
E
Eurostars
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Arm Use With Soft-robotic Glove
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 (652 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Roessingh Research and Development
Enschede, Overijssel, Netherlands, 7522AH
Actively Recruiting
Research Team
G
Gerdienke Prange, PhD
CONTACT
A
Anke Kottink, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here