The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder

Primary outcomes

1. Performance of the upper limb module 2.0 (PUL 2.0)

   Time frame: Before orthosis wear & After orthosis wear and operation

   The Performance of the Upper Limb module (PUL) was specifically designed to assess upper limb function across the spectrum of function in patients with neuromuscular disorder, providing information on three domains of upper limb function (shoulder, middle, distal) and overall upper limb functional abilities. Each domain (shoulder, middle, distal) can be scored separately, and the scores from the three levels are summed up to a maximum of 44 points.

2. Active Range of motion

   Time frame: Before orthosis wear & After orthosis wear and operation

   Measurement of range of motion is assessed using a goniometer, with the evaluator measuring the active range of motion of the shoulder joint in the same position before and after orthosis wear using the same tool. The measurement is taken with the trunk as the center, and the flexion/extension and abduction/adduction of the humerus are each measured three times, with the average value used.

3. Functional workspace

   Time frame: Before orthosis wear & After orthosis wear and operation

   Functional workspace analysis consists of 7 movements, where participants are asked to touch specific body parts in sequence: 1. Belly button, 2. Back pocket, 3. Same-side shoulder, 4. Opposite-side shoulder, 5. Mouth, 6. Top of head, 7. Back of head using both right and left hands. Analysis of functional workspace is manually performed based on recordings from 2 video cameras. Scores are assigned on a 4-point scale: 0 indicates inability to perform the task, 1 indicates reaching 0-49% of the target location, 2 indicates reaching 50-99% of the target location, and 3 indicates reaching the target location completely. Cumulative scores are calculated for all movements.

4. Goal Attainment Scale (GAS)

   Time frame: Before orthosis wear & After orthosis wear and operation

   Setting GAS goals is based on selecting the three most urgent issues among the problems the patient has based on the initial clinical assessment scores, with sufficient consideration given to the opinions of the patient and caregivers through interviews. Subsequently, three specific goals are selected based on the most urgent problems identified by the research team meeting.

5. Surface electromyography (sEMG)

   Time frame: Before orthosis wear & After orthosis wear and operation

   • Measurement Tasks:

   The following items are selected based on the examiner's judgment, with 3-5 items chosen for measurement:

   i. Shoulder abduction with both arms raised above the head ii. Shoulder height arm raising (based on elbow position) iii. Shoulder flexion at shoulder height iv. Moving wooden blocks v. Pouring water into a cup vi. Placing hand on the abdomen vii. Placing hand in the back pocket viii. Placing hand on the shoulder of the same side ix. Placing hand on the shoulder of the opposite side x. Brushing teeth xi. Brushing front hair

   C. Sensor Attachment Sites:

   • Selected based on the measurement task: i. Anterior/Middle Deltoid (dominant) ii. Biceps Brachii (dominant) iii. Upper Trapezius (dominant) iv. Sternocleidomastoid (dominant) v. External/Internal Oblique Muscles (both sides) vi. Longissimus muscles (both sides)

   D. Sensor Signal Parameters:

   • EMG Parameters: Amplitude after Rectification (RMS), area, percentage ratio of amplitude to RVC during motion.

6. Heart rate

   Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)

   changes in heart rate

7. Blood pressure

   Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)

   changes in blood pressure in systolic and diastolic

8. Numeral Rating Scale for Pain

   Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)

   changes in pain score using Numeral Rating Scale

9. Box and block test

   Time frame: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)

   A wooden box with a partition will be used with wooden blocks placed in one side of the box.

   The box is placed longitudinally on a table in front of the participant. The side of the box containing 150 blocks is positioned on the side of the hand being tested.

   The participant is instructed to move as many blocks as possible, one at a time, from the starting compartment to the empty compartment by reaching over the central partition, within a specified time limit.

   The researcher provides a clear demonstration of the task, emphasizing that blocks must clear the partition and enter the opposite side completely.

   A 15-second practice trial is administered first to ensure the participant understands the directions and task demands.

   A 60-second test trial is administered for each hand, starting with the dominant hand. The stopwatch starts when the participant's hand touches the first block and stops precisely at 60 seconds.