Arm Use With Soft-robotic Glove

Roessingh Research and Development

Status

Active, not recruiting

Conditions

Trauma Injury of Hand Multiple

Neurologic Disorder

Treatments

Device: Carbonhand

Study type

Interventional

Funder types

Other

Identifiers

NCT06033027

85214

Details and patient eligibility

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.

Enrollment

5 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion 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

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