The primary objective is to determine comfort thresholds for prolonged exposure to repetitive normal and shear stress exerted to the human thigh via a cuff with straps, using different force patterns comparable to those exerted during exoskeleton…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
not applicable (healthy)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the level of discomfort as indicated continuously
by the participants through a slider with a visual analogue scale. The scale
reaches from no discomfort at all to maximum imaginable discomfort. A separate
switch which releases all forces if activated by the participant is used to
detect onset of pain.
Secondary outcome
The secondary study parameters are the number of completed test
sessions/dropouts, subject characteristics (height, weight, age, gender),
records of observations of skin changes or other negative signs (directly after
force application and several days after the session), and surface EMG
recordings of the rectus femoris muscle.
Background summary
Exoskeletons can be used for rehabilitation, as assistive device for patients,
or to support workers during strenuous tasks. To fulfil their purpose, they
need to apply forces to the user*s musculoskeletal system. The forces are
transmitted at skin level through an interface, often in the form of cuffs.
Adverse events causing discomfort and injuries to the skin and underlying
tissue can be attributed to those interaction forces. While there is some
information about safe limit values for impact forces or pressure and shear
applied for short durations, little is known regarding comfort and safety
thresholds for repetitive forces applied over long durations as is the case in
exoskeleton use. This study therefore aims at gaining new knowledge on safe and
comfortable limit values for continuous repetitive shear and normal forces
applied through a cuff.
Study objective
The primary objective is to determine comfort thresholds for prolonged exposure
to repetitive normal and shear stress exerted to the human thigh via a cuff
with straps, using different force patterns comparable to those exerted during
exoskeleton use. The secondary objectives are to determine the feasibility of
the experiment, the influence of subject characteristics on comfort thresholds,
the occurrence of skin injuries or other negative signs, and whether
characteristics of muscle activity can be related to discomfort.
Study design
The study is a cross-sectional intervention study with one measurement session,
where participants will provide a continuous comfort rating during exposure to
repetitive normal and shear forces.
Intervention
A pre-defined set of prolonged repetitive force patterns will be applied to
each participant*s thigh though a contact force which is similar to cuffs
commonly used in gait exoskeletons. The forces will be applied by a custom made
actuated test device and are based on normal use of exoskeletons.
Study burden and risks
The study is non-therapeutic, so no direct benefits for the participants are
involved. The procedures are non-invasive and safety measures are taken to
avoid excessive force exertion to the participants or other unsafe situations.
Therefore, subjects suffer no negative effects or disadvantages, except for the
invested time and the discomfort experienced during the force execution. Pain
will be avoided as participants can trigger a release of the forces at any
time. Any changes to the participants* skin or other negative signs will be
monitored and followed up on until they have resolved.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
• Between 18 and 35 or between 55 and 85 years of age
• Able to provide informed consent
Exclusion criteria
• Unable to follow simple instructions
• Insufficient knowledge of the Dutch or English language to understand the
purpose and methods of the study
• Skin lesions at the thigh
• Sensory impairments
• Severe blood pressure fluctuations
• Inability to sit in required posture in experiment chair for 60 minutes
• Taking blood thinners or showing signs for increased bleeding tendency
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 | glinicaltrials.gov (tbd) |
CCMO | NL80800.091.22 |