The primary objective is to examine the effect of use of the assistive Carbonhand system during strenuous ADL tasks on the kinematic movement profile, compared to not using Carbonhand. Secondary objectives are to examine whether pain or discomfort…
ID
Source
Brief title
Condition
- Other condition
- Neuromuscular disorders
Synonym
Health condition
spierkrachtvermindering door veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the kinematic movement profile during a
high-demand ADL task (reaching/grasping/transporting a heavy object), as
measured by 3D motion capture (amongst others: movement duration, hand opening;
joint excursions; endpoint error).
Secondary outcome
Experienced pain/discomfort, handgrip strength and endurance, number of
repetitions of ADL task, muscle oxygen saturation and EMG parameters.
Background 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 CarbonHand 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.
Study objective
The primary objective is to examine the effect of use of the assistive
Carbonhand system during strenuous ADL tasks on the kinematic movement profile,
compared to not using Carbonhand. Secondary objectives are to examine whether
pain or discomfort is experienced in strenuous activities with the Carbonhand
system as well as the characteristics and locations of such pain/discomfort,
and to examine whether use of Carbonhand 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,
compared to not using Carbonhand.
Study design
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 Carbonhand system.
Intervention
All participants will perform each movement task with and without the
Carbonhand system. The Carbonhand system 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 burden and risks
The study is non-therapeutic, so no direct benefits for the participants are
involved. On the other hand, the study set-up involves non-invasive
measurements of movements that are at all times within a subjects ability.
Also, the device under study is a CE-marked device, minimizing risks associated
with its use. Therefore, subjects suffer no negative effects or disadvantages,
except for the invested time and effort and potentially some mild and transient
muscle aches due to the exertion during the movement tasks. As the mechanisms
underlying experienced fatigue and/or overload in the previous study in
association with Carbonhand use are bound to the study population involved in
the previous study, this study should also be conducted with a similar study
population.
Roessinghsbleekweg 33b
Enschede 7522AH
NL
Roessinghsbleekweg 33b
Enschede 7522AH
NL
Listed location countries
Age
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)
• Severe proximal weakness (MRC shoulder elevation<4)
• 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
• Severe acute pain of the most-affected hand
• Used the CarbonHand system in the past 3 months
• Wounds on the hands that can provide a problem when using the glove
• Severe contractures limiting passive range of motion
• Co-morbidities limiting functional use/performance of the arms/hands
• Severe spasticity of the hand (>=2 points on Ashworth Scale)
• Severe proximal weakness (MRC shoulder elevation<4)
• Insufficient knowledge of the Dutch language to understand the purpose or
methods of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | in aanvraag bij ClinicalTrials.gov |
| CCMO | NL80144.091.21 |