MedPath

Single-handed, double loaded

Conditions
Individuals with a congenital or acquired upper limb absence, individuals with brachial plexus injury
Registration Number
NL-OMON24626
Lead Sponsor
MCG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 18 and older
- Able to give written informed consent
- Able to read/understand Dutch or English
- All questions of the Physical Activity Readiness Questionnaire (PAR-Q) answered with no”, and therefore assuming that executing physical activities is reasonably safe.

Specific criteria per subgroup:
- Upper limb absence (ULA): defect at transhumeral, transradial, elbow disarticulation or wrist disarticulation level, so the maximum voluntary contraction (MVC) protocol as part of the movement protocol can be executed.
- Brachial plexus injury (BPI): a score between 0 and 8 on the questionnaire about functional movements of the hand, meaning almost no function of the hand.
- In case of acquired ULA or BPI: = 1 year after amputation or injury
- Able bodied controls: matching based on gender and age group (+ or – 5 years)
- MSC: answered with yes” on the first two questions about MSC in the questionnaires for the participants. Having complaints like pain, stiffness and tingling of the muscles, bones, nerves and/or joints that are NOT the result of an accident, an infection, a sport injury or a joint disease, occurring for at least four weeks in the past year.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Incapacity to follow instructions
- Manifest co-morbidity, other than MSC, leading to restrictions in physical or mental functioning that interfere with the measurement results. Examples: fractures of the upper extremity bones, muscle dystrophies or stroke.
- Lower extremity complaints, otherwise the legs cannot be used as reference test site in the Quantitative Sensory Testing (QST)

Specific criteria per test:
- QST: signs or suspicion of neurological dysfunction at tested sites
- Capacity tests: history of medical disorder that influence heart rate or use of medication that influences heart rate (for example beta-blockers)

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
For the central sensitization protocol the main outcome measures are the Central Sensitization Inventory (CSI) questionnaire and the Quantitative Sensory Testing (QST) outcome measures. The primary outcome measures for the movement protocol are muscle fatigue, upper extremity angles, muscle activity and force.
Secondary Outcome Measures
NameTimeMethod
Secondary study parameters are heart rate, the Borg CR10 scale and the functionality asssesed with the outcome parameters of the Jebsen Taylor Hand Function Test (JTHFT) and the Functional Capacity Evaluation for One-Handed individuals (FCE-OH).
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