Feasibility of a randomised controlled trial of lycra sleeve for management of glenohumeral subluxation (GHS) in people with stroke

Kumar, Praveen; Jones, Robert; Easton, Chris; Turton, Ailie

Abstract

Introduction: Glenohumeral subluxation (GHS) is a common secondary complication reported in up
to 81% of people with stroke. The aims of this study was to evaluate the feasibility of conducting a fully
powered randomised controlled trial of the Lycra sleeve for the management of GHS.
Method: Stroke survivors over 18 years with hemiplegia, muscle strength of3 on Medical Research
Council scale, able to provide informed written consent were recruited. Settings: In-patient rehabilitation.
Evaluation points were at baseline and at three months. Intervention: Patients were randomised
to immediate or delayed (received sleeve at 3 months) groups. Staff, patients and carers received
training on application of sleeve. Outcome measures: Recruitment, retention, adverse events and
completeness of data collection were explored at 3 months. Measurements included: Ultrasound
method (GHS), Passive range of movement, muscle strength, Modified Ashworth Scale, upper limb
function: Motor assessment scale, Health Survey-12 or EQ5D. A questionnaire explored acceptability.
Analysis: was conducted using descriptive statistics and thematic analysis of participant’s views of Lycra
Sleeve.
Results: Over 1 year period, the screening process identified 257 stroke survivors of whom 31 (12%)
were recruited. N¼19 were assigned to immediate group. Overall retention was 27 (87%) and all
patients tolerated clinical outcome measures. Mean AGT distance was 2.20.6 cm at baseline and
2.10.4 cm at follow-up. Average days sleeve worn was 50/90 days with a mean time of 10 hrs/day. In
total, 7 (41%) immediate group participants and two (22%) delayed group participants showed reduction
in GHS. Majority of participants (n¼25) reported no adverse reaction.
Conclusion: Recruitment was low but retention was good. This study found that a subsequent clinical
trial was feasible, however, modifications to the recruitment strategy are required.

• Presentation Conference Type: Conference Paper (published)
• Conference Name: UK Stroke Forum 2019
• Acceptance Date: Aug 23, 2019
• Online Publication Date: Dec 3, 2019
• Publication Date: 2019-12
• Deposit Date: Dec 10, 2022
• Journal: International Journal of Stroke
• Print ISSN: 1747-4930
• Electronic ISSN: 1747-4949
• Publisher: SAGE Publications
• Volume: 14
• Issue: 4
• Pages: 9-55
• Series Title: UK Stroke forum 2019 Abstract Supplement
• DOI: https://doi.org/10.1177/1747493019882907
• Keywords: Neurology, Stroke, GHS, Glenohumeral subluxation
• Public URL: https://uwe-repository.worktribe.com/output/10235542
• Publisher URL: https://journals.sagepub.com/doi/10.1177/1747493019882907