Soft-robotic Glove Support of High-demand Tasks

NCT05318638 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-24

No results posted yet for this study

Summary

The hand is important to perform activities of daily living (ADL). However, many people experience a loss of hand function as result of a traumatic brain injury, spinal cord injury, stroke or orthopedic problems, or due to ageing. To improve hand function, or reduce its decline, one can benefit from exercise therapy or use of assistive aids to improve ADL independence. A promising innovative approach combining both is a wearable soft-robotic glove that supports hand grip. With this glove, performance of functional activities can be supported directly, while also facilitating repeated use of the affected arm and hand during functional daily activities. One of our previous studies showed that besides a direct support effect, a therapeutic effect on performance was found after several weeks of using the soft-robotic glove as support during ADL. However, several participants reported complaints of increased pain and/or overload, mainly at the beginning of the trial. Clinicians suspect that a (too) high intensity of hand use compared to normal is contributing to this observation. This might be related to more fatigue experienced when using the glove in high-demand tasks, due to a larger movement capacity (faster, further, more repetitions) and can be associated with decreased blood perfusion/lower saturation levels at muscular level and altered muscle activation and movement coordination.

Therefore, the primary objective is to examine the effect of use of the assistive soft-robotic glove during strenuous ADL tasks on the kinematic movement profile, compared to not using the soft-robotic glove. Secondary objectives are to examine whether pain or discomfort is experienced in strenuous activities with the soft-robotic glove as well as the characteristics and locations of such pain/discomfort, and to examine whether use of the glove is associated with increased handgrip strength, larger number of ADL task repetitions, diminished blood perfusion / reduced tissue saturation at the muscle and/or changes in muscle activity.

Conditions

Interventions

DEVICE

Soft robotic glove

The soft-robotic glove used in the study is the Carbonhand system (Bioservo Technologies, Sweden). It is a CE-marked medical device and it consists of a glove that supports finger flexion via sewn-in tendons and a control unit housing the actuators that pull on the tendons and the batteries. The grip support is activated by applying very light pressure on sensors in the fingertips of the glove, and de-activated by releasing the pressure on the sensors.

Sponsors & Collaborators

  • Roessingh Research and Development

    lead OTHER

Principal Investigators

  • G. Prange, PhD · Roessingh Research and Development

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318638 on ClinicalTrials.gov