Influence of assistive soft-robotic glove use on actual arm use in daily life

Recruiting

Conditions: patients with hand limitations due to trauma-related injuries or neurologic disorders
trauma-related injuries
neurologic disorders

Registration Number: NL-OMON56312

Lead Sponsor: Revalidatiecentrum Het Roessingh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

• Age between 16 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is actual arm use as measured by two MotionWatch8<br /><br>devices, containing an accelerometer, one around each wrist. In essence, the<br /><br>raw accelerometer signal will be transformed into an activity count signal.<br /><br>Actual amount of arm-hand use will then be calculated in several ways, focusing<br /><br>on the duration of use and the intensity of use of the affected arm-hand.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Maximal grip strength and survey questions about perceived hand function and<br /><br>overall wellbeing, in addition to glove use data, hand function, perceived<br /><br>amount and quality of hand use and pain, and quality of life questionnaires.</p><br>