Status:
ACTIVE_NOT_RECRUITING
Arm Use With Soft-robotic Glove
Lead Sponsor:
Roessingh Research and Development
Collaborating Sponsors:
Eurostars
Conditions:
Trauma Injury of Hand Multiple
Neurologic Disorder
Eligibility:
All Genders
18-90 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06033027
Start Date
June 3 2024
End Date
October 1 2024
Last Update
August 29 2024
Active Locations (1)
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1
Roessingh Research and Development
Enschede, Overijssel, Netherlands, 7522AH