Objectives: To compare the efficacy of a newly designed cus- tom-fitted shoulder subluxation orthosis (SSO) with a commercial Bobath sling for shoulder subluxation in stroke patients.

Study design: A single-blinded crossover randomized con- trolled trial.

Setting: Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Subjects: Sixteen post-stroke patients with hemiplegia/hemiparesis Methods: A radiologist measured the acromiohumeral (AH) distance in anterior-posterior view radiographs of normal and affected shoulders of patients in a sitting position when not using any orthosis, when wearing a Bobath sling which supports the proximal humerus only, and when wearing an SSO. Comparison of the AH distance was conducted using the paired t-test. Results: Without any orthosis, the mean (SD) of the affected and normal shoulders were 47.9 (7.5) and 36.2 (4.6) mm, respective- ly. The AH distance of the affected shoulder while wearing SSO was reduced to 36.8 (4.7) mm which is not statistically significant different from the normal shoulder distance (p = 0.49), whereas the mean AH distance wearing a Bobath sling was only reduced to 44.9 (7.7) mm., statistically significantly greater than the normal shoulders (p < 0.01).

Conclusions: The newly designed custom-fitted proximal-distal type shoulder subluxation orthosis for hemiplegia/hemiparesis patients, can reduce the AH distance significantly closer to that of a normal shoulder than a Bobath sling.