The Effect of Shoulder Support on Shoulder Subluxation in Stroke Survivors Based on Ultrasonography Findings: A Randomized Clinical Trial

OBJECTIVE: This study evaluated the effectiveness of a standardized shoulder support in reducing shoulder subluxation, alleviating pain, and improving upper limb motor function and functional independence in stroke survivors using ultrasonography as the primary outcome measure for subluxation. METHODS: In this single-blind randomized controlled trial, 40 stroke survivors with clinically confirmed shoulder subluxation were randomly allocated to either an intervention group (n = 20) or a control group (n = 20). Both groups received conventional rehabilitation consisting of 45-min sessions, 5 days per week, over a seven-week period. Participants in the intervention group additionally wore a standardized shoulder support during waking hours. Outcome evaluations were performed at baseline (before the intervention), week 3 (mid-intervention), and week 7 (end of the intervention) by independent assessors (physicians and rehabilitation therapists) who were blinded to group allocation. The primary and secondary endpoints included ultrasonographic measurement of the Acromion-Greater Tuberosity (AGT) distance, pain intensity assessed by the visual analog scale (VAS), upper extremity motor performance measured with the Fugl-Meyer Assessment (FMA), and functional independence evaluated using the Functional Independence Measure (FIM). RESULTS: Within-group analyses revealed statistically significant changes in shoulder subluxation (p = 0.02), pain reduction (p < 0.001), upper limb function (p < 0.05), and functional independence (p = 0.001) in both groups over time. However, between-group comparisons showed no significant differences in any of the outcome measures (p > 0.05). CONCLUSION: Adding a standardized shoulder support to conventional rehabilitation did not produce a statistically significant additional benefit over 7 weeks in reducing shoulder subluxation, pain, or improving upper-limb motor function and functional independence. The observed changes over time should be interpreted in the context of rehabilitation received by both groups, spontaneous recovery, and other time-related factors cannot be distinguished.