Evaluation of a Textile Scapula Orthosis
Condition: Muscular Dystrophies; Scapular Dyskinesis; Muscular Dystrophy, Facioscapulohumeral; Muscle Weakness; Muscular Weakness; Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscle Weakness; Muscular Dystrophy, Facioscapulohumeral; Asthenia
Study type: Interventional

Summary: 
      Shoulder instability due to muscle weakness is a common problem in disorders of the upper
      extremities. During arm motion, the scapula acts as a dynamic base for the humeral head. To
      safely move the shoulder with an exoskeleton for the upper extremities a textile orthosis was
      developed that stabilizes the scapula against the thorax. The support level of the orthosis
      is continuously manually adjustable. To test the feasibility of our design and to improve the
      functionality of the textile orthosis, it needs to be investigated how the orthosis acts on
      people affected by shoulder instability. The investigators seek to explore how people with
      shoulder instability respond to the orthosis, and how they may benefit from the orthosis
      function. Therefore, the range of motion of arm elevation will be compared in different
      conditions: (i) without any support, (ii) with the support of a trained therapist, and (iii)
      when the device is engaged at the individual's optimal support level. Additionally, pilot
      tests will be performed to fix different parameters in our study protocol, such as the the
      optimal orthosis stiffness level and the ideal number of movement repetitions.
    

Detailed description: 
      In this study, participants suffering from muscular weakness in the upper extremities,
      particularly the shoulder joint, will be recruited. A clear indicator for muscular weakness
      in the shoulder joint is a scapula alata (winging scapula). Hence, participants recruited for
      this study should present with a scapula alata and a limited RoM of at least one of their
      upper extremities.

      This study is designed as a cross-over trial. Each participant will take part in an
      experimental session that will last approximately 2 hours. At the beginning of the
      experiment, the participant will be informed about the measurement and sign the informed
      consent sheet. Additional demographic data and level of ability will be collected in a
      questionnaire.

      Before the measurements, participants will be fitted a textile scapula orthosis. The orthosis
      will be instrumented to quantify the amount of support the orthosis provides to the user.
      Therefore, an array of force sensors is mounted between the orthosis and the skin to measure
      the qualitative force distribution and its rate of change. To measure the absolute force
      applied to the plate, a load cell will be mounted on the orthosis fastening mechanism. All
      force data will be collected synchronously through a Micro-Controller board.

      The participants will be equipped with reflective adhesive markers to define the reference
      points for the range of motion measurements, which will be done with a goniometer and
      photographic opto-electronic motion tracking.

      Nine blocks of measurements will be conducted, lasting 5 minutes each. The remaining time in
      the study accounts for rest periods, the mounting and demounting of the orthosis,
      instructions and questionnaires. The first eight blocks will present the following treatment
      conditions in randomized order:

        -  No support (NO): the scapula is not assisted during arm elevation.

        -  Manual scapular assistance (SA): a trained person assists the scapula during arm
           elevation manually.

        -  Orthosis support (OS): the scapula is assisted by the textile orthosis set to
           meaningfully different force levels.

        -  Motor control task (MT): The participant reaches for a target placed at the maximum
           elevation height in the NO condition, once without and once with the orthosis.

      While one block each is performed in the NO, SA and MT conditions, six blocks are performed
      in the OS condition with the orthosis set to meaningfully different force levels.

      In each measurement set, participants will elevate their arms in one of two planes of
      horizontal rotation:

        -  30° (R30) as measured from the coronal body plane.

        -  80° (R80) as measured from the coronal body plane.

      During arm elevation, the arm is fully extended, i.e. the elbow and wrist are fully
      stretched. In this position, the center of mass has the largest lever arm and therefore the
      maximum torque due to gravity occurs in the shoulder. One measurement set will be done in
      each elevation plane. During the OS condition, the orthosis will be opened between
      measurement sets to allow for comfort and unhindered breathing and to guarantee independence
      of measurement data.

      After the experiment, the perceived exertion and orthosis comfort will be assessed using the
      Borg Scale and the Nordic Questionnaire.

      Before the study, several study parameters will be determined in pilot studies with variable
      duration, not exceeding 2 hours. The participants in the pilot studies and the final study
      might be identical. During the pilot tests, participants will wear an orthosis similar to the
      one used in the study. Hence, effort and strain for participants will be equal or less to the
      final study. The pilot tests include

        -  Definition of optimal pressure and protocol to consistently find this pressure.

        -  Definition of optimal orthosis configuration.

        -  Definition of repeatability when orthosis is unmounted and mounted again.

        -  Definition of meaningful difference between pressure levels.
    

Intervention name(s): Scapula orthosis assistance; Manual scapula assistance; No assistance; Functional Test
Intervention type(s): Device; Procedure; Other; Other
Intervention description(s): Participants are elevating their arm while their scapula is assisted by the scapula orthosis; Participants are elevating their arm while their scapula is assisted by a trained personnel; Participants are elevating their arm without being assisted; Participants perform a functional test once without (NO) and once with (OA) the orthosis
Other intervention name(s): OA; MA; FT
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All patients perform the experiment in all conditions. The without orthosis, with orthosis and manual assistance conditions will be presented in randomized order, followed by the functional task.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Scapula alata; Scapular winging; Scapula orthosis; Range of Motion; Movement control; Manual Scapula Assistance