Neuromuscular DiseasesNCT05318638
Soft-robotic Glove Support of High-demand Tasks
A study testing Soft robotic glove in people with Neuromuscular Diseases and Sarcopenia, run by Roessingh Research and Development at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuromuscular Diseases, Sarcopenia
- What is being tested?
- Soft robotic glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Roessingh Research and Development
Enschede, Overijssel, 7522AH
About this study
Official title: Changes in Movement Profile Related to Use of a Soft-robotic Glove During High-demand Tasks
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.
Read the 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
- Being tested
- Soft robotic glove
- Keywords
- Soft-robotic glove, Wearable device, Hand function, Movement analysis
- Medical subject headings
- Neuromuscular Diseases, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft robotic gloveDevice
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 | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Soft robotic glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 hours during the measurement session
Secondary outcomes (7)
Experienced pain/discomfort rating + description
Discomfort and pain in the hand experienced by the participants will be assessed using a report form, indicating the amount of experienced pain and/or discomfort (using Visual Analogue Scales), and in case of discomfort or pain, a map of the hands to localize the pain/discomfort and a description of its sensation as well as an assumed cause. This will be done separately for each area in which discomfort and/or pain is reported.
Measured: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
Perceived exertion and confidence in grip rating
Perceived exertion/fatigue after the strenuous ADL tasks will be assessed using the Borg Rating Scale of Perceived Exertion. An additional question assesses the participants' confidence in their grip on the object as experienced during the ADL task performance.
Measured: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
Maximal handgrip strength
The maximal handgrip strength will be measured with a custom-made cylindrical dynamometer, recording the maximum force a person can exert on the dynamometer by forcefully gripping the cylinder. This will be done three times, if the last attempt is done with higher force than the second-to-last attempt, another attempt will be added, until the last value is lower than the second-to-last value.
Measured: 1-2 hours during the measurement session
Handgrip endurance
Handgrip endurance will also be measured with a custom-made cylindrical dynamometer. It will be measured in a static situation, by prolonged max contraction of hand grip during 30 seconds.
Measured: 1-2 hours during the measurement session
Number of repetitions achieved during ADL task
The number of repetitions achieved during execution of the ADL task (i.e., number of times the task was completed succesfully) in the four different conditions (no glove and unsupported max weight, no glove and supported max weight, glove and unsupported max weight, glove and supported max weight) will be recorded.
Measured: 1-2 hours during the measurement session
Muscle tissue oxygen saturation
The muscle oxygen saturation in the forearm is measured during the ADL task execution and handgrip strength and endurance tests using a NIRS sensor placed over the M. flexor radialis and ulnaris and the M. flexor digitorum superficialis, secured with Velcro straps around the forearm.
Measured: 1-2 hours during the measurement session
Amplitude, on/off times and median frequency of muscle activity
Muscle activity parameters will be calculated from surface EMG recordings of Abductor pollicis brevis, Extensor digitorum, Extensor carpi radialis, Extensor carpi ulnaris, Extensor pollicis brevis/longus, Flexor carpi ulnaris, Flexor carpi radialis
Measured: 1-2 hours during the measurement session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start17 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: A lower enrolment rate than expected, combined with the necessary information provided by the study, despite fewer participants being enrolled than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roessingh Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. Prange, PhD, Principal investigator, Roessingh Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318638
- Sponsor's protocol ID
- 80144
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Movement Profile Related to Use of a Soft-robotic Glove During High-demand Tasks
- ClinicalTrials.gov ID
- NCT05318638
- Acronym / sponsor ID
- 80144
- Conditions
- Neuromuscular Diseases, Sarcopenia
- Keywords
- Soft-robotic glove, Wearable device, Hand function, Movement analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A lower enrolment rate than expected, combined with the necessary information provided by the study, despite fewer participants being enrolled than anticipated.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Roessingh Research and DevelopmentUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Device: Soft robotic gloveAll 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Frail elderly with reduced hand function:
- Neuromuscular patients:
Key exclusion criteria (11 listed)
- Frail elderly with reduced hand function:
- Neuromuscular patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft robotic gloveThe 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. | Device | Study group |
Primary outcome
Kinematic movement profile during performance of strenuous ADL task
Time frame: 1-2 hours during the measurement session
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
7 secondary outcomes
Experienced pain/discomfort rating + description
Time frame: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
Perceived exertion and confidence in grip rating
Time frame: Twice during the measurement session, after completion of both conditions, with a duration of 5-10 minutes.
Maximal handgrip strength
Time frame: 1-2 hours during the measurement session
Handgrip endurance
Time frame: 1-2 hours during the measurement session
Number of repetitions achieved during ADL task
Time frame: 1-2 hours during the measurement session
Muscle tissue oxygen saturation
Time frame: 1-2 hours during the measurement session
Amplitude, on/off times and median frequency of muscle activity
Time frame: 1-2 hours during the measurement session
Results and safety
The study was stopped early (reason given: A lower enrolment rate than expected, combined with the necessary information provided by the study, despite fewer participants being enrolled than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Prange, PhD principal investigator
Roessingh Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft robotic glove in people with Neuromuscular Diseases and Sarcopenia, run by Roessingh Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A lower enrolment rate than expected, combined with the necessary information provided by the study, despite fewer participants being enrolled than anticipated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic movement profile during performance of strenuous ADL task (time frame: 1-2 hours during the measurement session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.