Functional orthosis in shoulder joint subluxation after ischaemic brain stroke to avoid post-hemiplegic shoulder–hand syndrome: a randomized clinical trial

Abstract

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.