Arm Use With Soft-robotic Glove

NCT ID: NCT06033027

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-10-31

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 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.

Conditions

Trauma Injury of Hand Multiple; Neurologic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Baseline phase

Group Type: NO_INTERVENTION

No interventions assigned to this group

Soft-robotic glove phase

Group Type: EXPERIMENTAL

Carbonhand

Intervention Type: DEVICE

During this phase, participants use the Carbonhand soft-robotic glove system in daily life for 6 weeks to support the performance of daily activities with their affected hand in the home environment. The participants are free to choose for which activities, when and for how long they use the Carbonhand. However, it is recommended to use the Carbonhand at least 180 minutes a week during the most common ADL, such as household activities, dressing/undressing, eating/drinking/cooking, and/or leisure activities.

Retention phase

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Carbonhand

During this phase, participants use the Carbonhand soft-robotic glove system in daily life for 6 weeks to support the performance of daily activities with their affected hand in the home environment. The participants are free to choose for which activities, when and for how long they use the Carbonhand. However, it is recommended to use the Carbonhand at least 180 minutes a week during the most common ADL, such as household activities, dressing/undressing, eating/drinking/cooking, and/or leisure activities.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurostars

OTHER

Sponsor Role: collaborator

Roessingh Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerdienke Prange, PhD

Role: PRINCIPAL_INVESTIGATOR

Roessingh Research and Development

Locations

Roessingh Research and Development

Enschede, Overijssel, Netherlands

Countries

Netherlands

Other Identifiers

85214

Identifier Type: -

Identifier Source: org_study_id