Soft-robotic Glove Support of High-demand Tasks

NCT05318638 | Terminated

• 1 other identifier: 80144
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Neuromuscular Diseases

Keywords

Soft-robotic glove; Wearable device; Hand function; Movement analysis

Outcome Measures

Primary Outcomes (1)

• Kinematic movement profile during performance of strenuous ADL task

  The kinematic movement profile during performance of strenuous ADL task, characterized by the following parameters as assessed using 3D marker-based motion capture: • Total movement duration * Duration of movement phases * Movement smoothness * Trunk displacement * Peak hand velocity * Time to peak velocity of reach phase * Hand opening * Joint excursion of the elbow * Joint excursion of the wrist * Endpoint straightness * Endpoint error

  1-2 hours during the measurement session

Secondary Outcomes (7)

• Experienced pain/discomfort rating + description

  Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.

• Perceived exertion and confidence in grip rating

  Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.

• Maximal handgrip strength

  1-2 hours during the measurement session

• Handgrip endurance

  1-2 hours during the measurement session

• Number of repetitions achieved during ADL task

  1-2 hours during the measurement session

Other Outcomes (1)

• Subject characteristics

  At the start of the measurement session, taking about 5 minutes

Study Arms (1)

Study group

OTHER

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).

Device: Soft robotic glove

Interventions

Soft robotic glove 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.

Study group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roessingh Research and Development: lead

Study Sites (1)

Roessingh Research and Development

Enschede, Overijssel, 7522AH, Netherlands

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Sarcopenia

Condition Hierarchy (Ancestors)

Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• G. Prange, PhD

  Roessingh Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is 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 (glove condition in randomized order).

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: April 8, 2022
• Study Start: October 17, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)