Soft-robotic Glove Support of High-demand Tasks

NCT ID: NCT05318638

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

A promising innovative approach to improve hand function is to integrate exercise therapy with support of activities of daily life using an assistive device. This is possible using 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.

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.

The study is set-up as a cross-sectional intervention study with one measurement session, where participants will perform maximum handgrip strength tests and high-demand ADL-tasks with and without the soft-robotic glove. The aim is to include 20 participants in total, 10 of which will be frail elderly and the other 10 will be neuromuscular patients, all suffering from reduced hand function.

All participants will perform each movement task with and without the 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. After execution of all tasks with and without glove, differences in outcome measures will be compared between glove conditions.

Conditions

Neuromuscular Diseases; Sarcopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study group

All participants in the study will perform arm/hand movement tasks in both of two conditions (with and without soft-robotic glove), so they constitute 1 study arm, but all receiving both intervention conditions (experimental - with glove and control - without glove).

Group Type: OTHER

Soft robotic glove

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Frail elderly with reduced hand function:

• Age between 65 and 90 years
• Experience difficulties in performing ADL due to a decline in hand function
• Able to make a pinch grip between thumb and middle or ring finger
• Sufficient cognitive status to understand two-step instructions
• Having (corrected to) normal vision
• Able to provide written informed consent
• Neuromuscular patients:

• Age between 18 and 80 years
• Experience difficulties in performing ADL due to a decline in hand function that can be attributed to a diagnosed neuromuscular disease
• Being in a chronic and stable phase of disease
• Able to make a pinch grip between thumb and middle or ring finger
• Sufficient cognitive status to understand two-step instructions
• Having (corrected to) normal vision
• Able to provide written informed consent

Exclusion Criteria

• Frail elderly with reduced hand function:

• Currently receiving treatment for a disease affecting arm/hand function
• Used the CarbonHand system in the past 3 months
• 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
• Severe spasticity of the hand (≥2 points on Ashworth Scale)
• Insufficient knowledge of the Dutch language to understand the purpose or methods of the study
• Neuromuscular patients:

• Severe sensory problems of the most-affected hand

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

Sponsors

Roessingh Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

G. Prange, PhD

Role: PRINCIPAL_INVESTIGATOR

Roessingh Research and Development

Locations

Roessingh Research and Development

Enschede, Overijssel, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

G. Prange, PhD

Role: CONTACT

g.prange@rrd.nl

+31 88875777

Facility Contacts

G. Prange, PhD

Role: primary

Other Identifiers

80144

Identifier Type: -

Identifier Source: org_study_id