Arm Use With Soft-robotic Glove

NCT06033027 | Recruiting

• 1 other identifier: 85214
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Actual arm activity

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

  During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), while wearing the MotionWatch for a day during waking hours (ca. 12h).

Secondary Outcomes (12)

• Grip strength

  During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), with supervision by researcher on videocall

• Michigan Hand Outcomes Questionnaire - Question 2 (MHQ-Q2)

  During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)

• Positive Health questionnaire

  During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)

• Glove use data

  Continuously and automatically during soft-robotic glove use phase (6 weeks) when soft-robotic glove is turned on and activated.

• Diary

  Continuously during soft-robotic glove use phase (6 weeks) when soft-robotic glove is used

Study Arms (3)

Baseline phase

NO INTERVENTION

Soft-robotic glove phase

EXPERIMENTAL

Device: Carbonhand

Retention phase

NO INTERVENTION

Interventions

Carbonhand 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.

Soft-robotic glove phase

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• Sufficient cognitive status to understand two-step instructions
• Having (corrected to) normal vision
• Able to provide written informed consent
• Living independently

You may not qualify 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)
• 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

Sponsors & Collaborators

• Roessingh Research and Development: lead
• Eurostars: collaborator

Study Sites (1)

Roessingh Research and Development

Enschede, Overijssel, 7522AH, Netherlands

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Gerdienke Prange, PhD

  Roessingh Research and Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerdienke Prange, PhD

CONTACT

+31 (0)88 087 5777; g.prange@rrd.nl

Anke Kottink, PhD

CONTACT

+31 (0)88 087 5777; a.kottink@rrd.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single case experimental design with multiple baselines

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: June 3, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)