The Lycra arm sleeve for treatment of glenohumeral subluxation in people with sub-acute stroke: a randomized controlled (RC) feasibility study.

Abstract

Background: A Lycra arm sleeve has the potential to reduce glenohumeral subluxation (GHS) in people with stroke (PwS). Aims were (1) to provide feasibility data to inform a future fully powered randomized controlled trial, (2) to understand whether patients would be willing to be randomized, (3) to measure changes in GHS at 3 months after wearing the sleeve when compared to not wearing the sleeve.

Method: PwS ≥18 years with ≤3/5 shoulder abduction strength and able to give informed consent were recruited. The feasibility data on recruitment, screening, and retention rate at 12 weeks were collected. Participants were asked if they would be happy to be randomized into one of the two groups. The immediate group received the Lycra sleeve on recruitment and wore for up to 10 hours/day for 3 months. The delayed group received the sleeve after follow-up assessment at 3 months. GHS was assessed using diagnostic ultrasound method.

Results: Over one year, 257 patients were screened, 34 patients were eligible, and 31 (91%) were recruited. Retention at 3 months was 27 (87%). Of those eligible, all found randomization to be acceptable. In the immediate group, GHS showed reduction from 2.6 ± 0.7 cm (95% CI 2.0-3.1 cm) at baseline to 2.2 ± 0.4 cm (CI 2.0-2.5 cm) at 12 weeks. In the delayed group, mean GHS remained unchanged over 3 months period (2.3 ± 0.5 cm, CI 1.9-2.7 cm).

Conclusion: Recruitment was harder than anticipated, but there was high retention demonstrating feasible methodology. There is some indication of a clinical effect of Lycra sleeve on GHS early after stroke.