(I) Compare shoulder loads estimated with musculoskeletal simulations, stability and associated muscular effort of subjects with FSHD and healthy controls during the performance of standardized upper extremity tasks with and without an arm support…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are shoulder loads and muscular effort
Secondary outcome
The secundary outcome measure is shoulder load calculated from intertial
magnetic measurements
Background summary
For people with Facioscapulohumeral dystrophy (FSHD), an assistive device in
the form of an arm support can effectively increase the range of motion by
compensating for the arm weight, thus ultimately resulting in an increased
functionality. However, the exact implications of arm support systems on
shoulder load, shoulder instability and muscle weakness have not been properly
investigated so far. Furthermore, current use rates of arm support systems are
sub-optimal. Users of these arm-support systems state that the device does not
fit their needs. To achieve a better fit however, a more thorough understanding
of the interaction between the user and the assistive device during activities
of daily living is necessary. Subjects will be asked to execute a standardized
movement protocol in the lab with and without using an arm support system. In
preparation of transferring to home measurements, movements will be recorded
with a portable measurement system in addition to traditional, laboratory
bound, motion capture equipment and EMG.
Study objective
(I) Compare shoulder loads estimated with musculoskeletal simulations,
stability and associated muscular effort of subjects with FSHD and healthy
controls during the performance of standardized upper extremity tasks with and
without an arm support. (II) Establish the feasibility and validity of
musculoskeletal shoulder load predictions in ambulatory settings.
Study design
Cross-sectional study in which two groups will be compared; a healthy group of
adults acting as control group and a group of adults with FSHD. Both groups
will be asked to complete the same movement protocol with and without arm
support.
Study burden and risks
The experiment consists of a single non-invasive measurement session, is
non-therapeutic in nature, and requires about two and a half hour. Given that
the movement-tasks lie within the range of activities of daily living, risk of
injury and burden for the participants are considered to be minimal. Currently,
limited information about the kinematic and dynamic changes in shoulder
functioning when using an arm-support is available for people with FSHD.
Obtaining this information cannot be done without investigating people with
FSHD, while they are using an arm-support system. Only limited reference values
concerning these kinematic and dynamic changes in shoulder functioning while
using an arm-support system exist. Therefore it is important to obtain insight
in these changes in healthy adults as well.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
Healthy: aged between 18-75 years old, able to read/understand Dutch, able to give informed consent
People with FSHD: aged between 18-75 years old, able to read/understand Dutch, able to give informed consent, able to transfer from wheelchair to chair with side- and lower back-rest, Brooke scale 3 or 4 (3 of both)
Exclusion criteria
Healthy: impaired arm/shoulder function, presence of pain in the shoulder, history of severe trauma of the shoulder in the previous two years (e.g. fracture, luxation)
People with FSHD: comorbidities that impair arm/shoulder function, incapable of abducting or elevating the arm > 30 degrees, previous surgery of the affected shoulder, extrinsic causes of shoulder pain, history of severe trauma of the shoulder in the previous two years (e.g. fracture, luxation)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | application Nederlands Trial Register pending |
| CCMO | NL55711.042.15 |
| OMON | NL-OMON26496 |