- To assess the POWERjar in measuring muscle fatigue, compared to simultaneous sEMG recording- To assess the POWERjar in measuring torque- To assess the POWERjar maximal grip force and compare to maximal grip strength measured with the Jamar…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
biomechanics
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- torque on POWERjar
- grip strength on POWERjar
- signal amplitude on sEMG
Secondary outcome
N/A
Background summary
To assess and quantify muscle function in neuromuscular disorders for clinical
trials, surface electromyography (sEMG) is currently the gold standard to
measure fatigability. However, although EMG is accurate, it also requires
specifically trained staff and might not reflect clinical relevance of muscle
dysfunction or weakness. The POWERjar is a measurement device that allows for
the recording of grip strength and opening / closing torque of a jar, which is
easy to use and distribute in late phase clinical trials. More importantly, it
also has clear clinical relevance, as it imitates a task that is a typical
activity of daily living.This device has only recently been developed and it is
not yet clear how variables yielded by PowerJar measurements (such as torque /
hand grip strength) relate to gold standard surface EMG and what the precision
is of these measurements in comparison to sEMG.
Study objective
- To assess the POWERjar in measuring muscle fatigue, compared to simultaneous
sEMG recording
- To assess the POWERjar in measuring torque
- To assess the POWERjar maximal grip force and compare to maximal grip
strength measured with the Jamar dynamometer.
- To assess the POWERjar in measuring time of release of grip.
Study design
Method validation study, parallel group, in healthy male and female volunteers.
Study burden and risks
Performing several hand function tests using grip strength and torque, sEMG
with stickers (no needles), no risks
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
1. Healthy male or female subjects, 21 to 80 years of age, inclusive. Healthy status is defined by absence of evidence a condition that might affect upper limb function, following an abbreviated medical screening.
2. Body mass index (BMI) between 18 and 35 kg/m2, inclusive.
3. Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
1. Concomitant disease or condition that, in the opinion of the Investigator, might affect upper limb function.
2. Unable to understand the study requirements and lifestyle restrictions as described in the informed consent form or unable to give informed consent due to the subject's cognitive status.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54720.056.15 |