Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial

Abstract

Objective: The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. Design: This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. Setting: In-patient rehabilitation. Subjects: The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation. Interventions: Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation ( n = 27), or to usual rehabilitation only ( n = 16). Main measures: Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. Results: Of the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. Conclusion: Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.

Implementation of Dynamic Lycra® Orthoses for Arm Rehabilitation in the Context of a Randomised Controlled Feasibility Trial in Stroke: A Qualitative study Using Normalisation Process Theory

“…These adaptations may partly explain findings of the feasibility trial, which indeed showed no indications of benefits of dynamic Lycra® orthoses on arm recovery in this population. 6 Any intervention adaptations need to be considered against the backdrop of "the fidelity and adaptation debate" 4 (p.39). This debate calls for a distinction between 'innovation', whereby skilled implementers adapt an intervention to better fit the context, and 'drift', whereby adaptations could potentially undermine an intervention's effectiveness.…”

“…Because of attrition, sub-groups were however too small for meaningful conclusions. 6 It is similarly unclear whether responses to orthosis wear might vary depending on when the orthosis is worn (eg, outside or during task practice). We prescribed orthosis wear for 8 h daily, according to manufacturer's guidance, intending that the orthosis would be worn during the most active parts of the day, including during task practice.…”

“…Full trial details and results are published elsewhere. 6 Occupational therapy, physiotherapy and nursing staff on the rehabilitation units and within community hospital rehabilitation teams were trained by researchers, and were responsible for implementing the orthoses with study participants. Their duties involved identifying potential participants, informing them about the study, supporting study participants to don and doff the orthoses, ensuring appropriate duration of wear, recording daily wear and rehabilitation activities, washing of the orthoses to manufacturer instructions and reporting adverse reactions to researchers.…”

Effects of pressure garment on spasticity and function of the arm in the early stages after stroke: a randomized controlled trial

“…Specifically, not covering the elbow joint could be a problem, as a published review 29 showed that spasticity is one of the major contributors that limit the arm movement after stroke at the elbow joint. The pressure garment wearing time was decided upon our review on published studies 14,16 with the suggestion that at least 6 hour/day stretching may be needed to prevent a muscle from developing into a contracture. Since we only referenced scar control guidelines when designing and fabricating the pressure garment, we could not ascertain if these guidelines were also suitable for use in stroke management.…”

“…2,13 To our knowledge, there were two studies that had investigated the effects of pressure garment on spasticity and arm function in stroke. 4,14 Gracies et al, 4 while investigating the effect of Lycra glove in hemiplegic individuals, found that the glove can improve wrist posture, reduce wrist and finger flexor spasticity, swelling in fingers, and improve passive range of movement in the shoulder. Morris et al, 14 most recently, found that there was a low retention rate of patients with dynamic Lycra orthoses with some having adverse reactions.…”