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New treatment option for Trauma Injury of Hand Multiple
Official title Arm Use With Soft-robotic Glove
ClinicalTrials.gov ID: NCT06033027
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Enschede, Overijssel, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Enschede, Overijssel, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.