Actively Recruiting
Influence of Assistive Soft-robotic Glove Use on Actual Arm Use in Daily Life
Led by Roessingh Research and Development · Updated on 2026-05-07
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Roessingh Research and Development
Lead Sponsor
E
Eurostars
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how using a supportive soft-robotic glove affects real arm and hand use during daily life for people with hand function limitations caused by trauma-related injuries or neurological conditions. This study follows up on earlier research with previous versions of the robotic glove (Carbonhand) to better understand its therapeutic effects. The study involves 3 to 5 participants and uses a single-case experimental design to observe changes over time. Participants will use the Carbonhand soft-robotic glove at home for six weeks during daily activities that are important to them, supporting the grip of their most affected hand. They can choose which activities and when to use the glove but are encouraged to use it at least 180 minutes per week. The study includes three phases: a baseline phase without the glove, the intervention phase using the glove, and a retention phase without the glove again. Throughout the 12 to 14 weeks of the study, participants will complete about 15 home assessments spread across the three phases. These assessments include wearing activity meters on both wrists during waking hours, performing hand grip strength tests via video calls, and answering questions on hand function and well-being. Additional evaluations involve questionnaires, hand function tests, pain ratings, and interviews. The glove also collects usage data and participants keep a diary during the intervention phase. This thorough monitoring helps researchers measure actual arm activity and other outcomes related to hand use and quality of life.
CONDITIONS
Brief Title
Arm Use With Soft-robotic Glove
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years
- Difficulties performing daily activities due to hand function limitations from trauma-related injury or neurological disorder
- Being in a chronic or stable phase of disease as judged by a physician
- Able to activate the soft-robotic glove by applying pressure on finger or palm sensors when grasping
- Ability to relax an active grip
- Sufficient cognitive ability to understand two-step instructions
- Having normal or corrected-to-normal vision
- Able to provide written informed consent
- Living independently
You will not qualify if you...
- Severe sensory problems in the most affected hand
- Severe acute pain in the most affected hand
- Wounds on the hands that interfere with glove use
- Severe contractures limiting passive range of motion so the glove cannot be worn or activated comfortably
- Co-morbidities limiting functional use or performance of arms or hands
- Severe spasticity of the hand (Ashworth Scale 2 or higher)
- Severe proximal weakness (Medical Research Council shoulder elevation less than 4)
- Use of the Carbonhand system in the past 3 months
- Participation in other studies affecting arm or hand function
- Receiving arm or hand function therapy during the study
- Insufficient digital literacy for video calls
- Insufficient understanding of Dutch or English to comprehend study purpose or methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 to 4 weeks
Participants are observed without any intervention to assess their usual arm use in daily life during this period.
5 home assessments intermittently during this phase
Duration - 6 weeks
Participants use the Carbonhand soft-robotic glove system in daily life for 6 weeks to support their affected hand during daily activities at home. Participants choose when and for how long to use the glove, with a recommendation to use it at least 180 minutes per week.
5 home assessments intermittently during this phase with continuous glove use data and diary entries
Duration - Approximately 2 to 4 weeks
Participants are observed again without intervention to assess retention of any changes in arm use after discontinuing the soft-robotic glove.
5 home assessments intermittently during this phase
Trial Site Locations
Total: 1 location
1
Roessingh Research and Development
Enschede, Overijssel, Netherlands, 7522AH
Actively Recruiting
Research Team
G
Gerdienke Prange, PhD
A
Anke Kottink, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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