Clinical trial NCT05318638: Soft-robotic Glove Support of High-demand Tasks
Official title: Changes in Movement Profile Related to Use of a Soft-robotic Glove During High-demand Tasks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Diseases
Sarcopenia
Keywords: Soft-robotic glove
Wearable device
Hand function
Movement analysis
Lead sponsor: Roessingh Research and Development
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Kinematic movement profile during performance of strenuous ADL task
timeFrame: 1-2 hours during the measurement session
Secondary outcomes:
measure: Experienced pain/discomfort rating + description
timeFrame: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
measure: Perceived exertion and confidence in grip rating
timeFrame: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
measure: Maximal handgrip strength
timeFrame: 1-2 hours during the measurement session
measure: Handgrip endurance
timeFrame: 1-2 hours during the measurement session
measure: Number of repetitions achieved during ADL task
timeFrame: 1-2 hours during the measurement session
measure: Muscle tissue oxygen saturation
timeFrame: 1-2 hours during the measurement session
measure: Amplitude, on/off times and median frequency of muscle activity
timeFrame: 1-2 hours during the measurement session
Other outcomes:
measure: Subject characteristics
timeFrame: At the start of the measurement session, taking about 5 minutes
Locations:
city: Enschede
country: Netherlands
facility: Roessingh Research and Development
state: Overijssel
Study officials:
affiliation: Roessingh Research and Development
name: G. Prange, PhD
role: PRINCIPAL_INVESTIGATOR
References: