Objective: To examine whether the use of a shoulder joint functional orthosis over four weeks can mitigate the development or progression of the shoulder-hand syndrome in patients with shoulder joint subluxation after stroke.
Design: Two-armed randomized controlled trial.
Setting: Rehabilitation unit of a neurological hospital, single centre.
Subjects: Forty-one patients with caudal subluxation of the glenohumeral joint and hemiparesis of the upper extremity after ischaemic brain stroke.
Interventions: Support by functional orthosis Neuro-Lux (Sporlastic, Nürtingen, Germany) on top of usual care according to current guidelines (experimental, n = 20) versus usual care alone (control, n = 21).
Main measures: Weekly shoulder-hand syndrome scores (severity of clinical symptoms ranging from 0 to 14), discomfort caused by the orthosis, and its usage rate. The primary outcome was the average shoulder-hand syndrome score on days 14, 21 and 28, adjusted for the baseline shoulder-hand syndrome score.
Results: The adjusted mean shoulder-hand syndrome score was lower by 3.1 in the intervention compared to the control subjects (95% confidence interval 1.9 to 4.3, P < 0.0001). Marginal or no discomfort from treatment with the orthosis was reported in 15 patients (75%), and only a single patient (5%) felt severe discomfort during the entire treatment. Use of the orthosis during the prescribed time was 89%.
Conclusions: The orthosis examined in this trial has been successfully shown to reduce and prevent the development of clinical symptoms of shoulder-hand syndrome. Timing and duration of application of the orthosis as well as its combination with other therapeutic measures should be investigated in future clinical trials.