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

Introduction: Glenohumeral subluxation (GHS) is a common secondary complication reported in upto 81% of people with stroke. The aims of this study was to evaluate the feasibility of conducting a fullypowered 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 ResearchCouncil 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 randomisedto immediate or delayed (received sleeve at 3 months) groups. Staff, patients and carers receivedtraining on application of sleeve. Outcome measures: Recruitment, retention, adverse events andcompleteness of data collection were explored at 3 months. Measurements included: Ultrasoundmethod (GHS), Passive range of movement, muscle strength, Modified Ashworth Scale, upper limbfunction: 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 LycraSleeve.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 allpatients tolerated clinical outcome measures. Mean AGT distance was 2.20.6 cm at baseline and2.10.4 cm at follow-up. Average days sleeve worn was 50/90 days with a mean time of 10 hrs/day. Intotal, 7 (41%) immediate group participants and two (22%) delayed group participants showed reductionin GHS. Majority of participants (n¼25) reported no adverse reaction.Conclusion: Recruitment was low but retention was good. This study found that a subsequent clinicaltrial was feasible, however, modifications to the recruitment strategy are required