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Dynamic consequences of arm support on shoulder function


- candidate number24058
- NTR NumberNTR5685
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2016
- Secondary IDsNL55711.042.15 , METc2015.959 ABR nr CCMO, METc UMCG
- Public TitleDynamic consequences of arm support on shoulder function
- Scientific TitleDynamic consequences of arm support on shoulder loads, stability and associated muscular effort in people with FSHD
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedNeuromuscular diseases, Shoulder instability, Arm function
- Inclusion criteria- Healthy adults:
o Men and women, aged between 18-65 years
o Able to read/understand Dutch
o Able to give written informed consent

- Adults with FSHD:
o Men and women, aged between 18-65 years
o Able to read/understand Dutch
o Able to give written informed consent
o Able to transfer from wheelchair to chair with side- and lower back-rest
o Brooke scale 3 or 4 (3 of both)
- Exclusion criteria- Healthy adults:
o Diagnosed pathologies that could interfere with the measurement results.
o Presence of pain in the shoulder.
o History of severe trauma of the shoulder within the previous two years (e.g. fracture, luxation).
o Prior experience in using the Gowing arm support.

- Adults with FSHD:
o Comorbidities that could interfere with the measurement results.
o Incapable of abducting or elevating (anteflexion) the affected arm > 30 degrees.
o Previous surgery of the affected shoulder.
o Extrinsic causes of shoulder pain.
o History of severe trauma of the shoulder within the previous two years (e.g. fracture, luxation).
o Prior experience in using the Gowing arm support
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type[default]
- Studytypeobservational
- planned startdate 1-apr-2016
- planned closingdate1-jan-2017
- Target number of participants30
- InterventionsCross-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.
- Primary outcomeThe primary outcome measures are shoulder loads and muscular effort
- Secondary outcomeThe secundary outcome measure is shoulder load calculated from intertial magnetic measurements
- TimepointsOne session, in which kinematics, muscular effort (% EMG) and inertial magnetic data will be collected.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD, Assistant Professor Alessio Murgia
- CONTACT for SCIENTIFIC QUERIESPhD, Assistant Professor Alessio Murgia
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Technologische Wetenschappen (STW), Focal Meditech BV
- Publications
- Brief summarySummary 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. Shoulder loads estimated with musculoskeletal simulations, shoulder stability and associated muscular effort of up to 15 subjects with FSHD and up to 15 healthy controls will be compared during the performance of standardized upper extremity tasks with and without an arm support system. In preparation of transferring to home measurements, movements will be recorded with a portable inertial magnetic measurement system in addition to traditional, laboratory bound motion capture equipment and EMG. The feasibility and validity of shoulder loads estimated with musculoskeletal simulations based on inertial magnetic data will be established.

Question1: How are muscular efforts of persons with FSHD and healthy controls related to shoulder loads and stability while per forming standardized upper extremity tasks with and without an arm support?
Hypothesis1: Activity changes in the muscles involved in scapular stability depend on the magnitude and direction of the shoulder load generated by the arm support. The activity onset of the muscles involved in scapular mobility will be affected by the arm support, while coordination strategies of these muscles will remain unaltered.

Question2: What is the feasibility and validity of musculoskeletal simulated shoulder load predictions based on inertial magnetic data.
Hypothesis2: Biomechanical outcome parameters from musculoskeletal simulations based on inertial magnetic data are expected to be similar to simulations based on Optotraks’ position data.
- Main changes (audit trail)29-apr-2017: EB
METC amendement:
Inclusion criteria: age 18-75 years in both groups (FSHD and healthy controls)
- RECORD1-mrt-2016 - 29-apr-2017


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