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

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.

This is a single-blind, two-arm parallel group, feasibility randomized controlled trial.

In-patient rehabilitation.

The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation.

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).

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.

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.

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.

Studies with children who have spastic hemiplegia caused by cerebral palsy suggest that wearing dynamic Lycra® orthoses as an adjunct to goal-directed training may improve movement and functional goal achievement.1 This evidence raises the question of whether the orthoses may be effective as an adjunct to rehabilitation in adults with arm impairments after stroke. Arm impairments, which include weakness and sensory loss, restrict independence in activities of daily living and affect stroke survivors’ quality of life.2

Dynamic Lycra® orthoses are commercially available dynamic braces that use tensile properties of Lycra® to generate torsion, correct muscle force imbalances across joints, optimize muscle length and functional positioning, and provide compression to enhance proprioception and sensory awareness.3,4 However, effectiveness in stroke rehabilitation has not been fully evaluated, despite anecdotal evidence that they are already in use in clinical practice. One single case study of 6 weeks wear in a survivor with long-standing stroke4 and a crossover trial with 16 stroke survivors 3–36 weeks after stroke onset3 involving only 3 hours orthosis wear have shown improvements in arm impairment, sensation and functional outcomes after orthosis wear. Evidence is therefore limited to low-quality study designs, and rigorous effectiveness studies are required.

The aim of this feasibility randomized controlled trial was to examine recruitment, retention, adverse events, intervention fidelity, magnitude and direction of difference in outcomes in stroke survivors receiving Lycra® orthoses as an adjunct to usual rehabilitation, compared to those receiving usual rehabilitation only. It also aimed to explore survivor and carer perceptions of acceptability, to inform decisions about a future definitive randomized controlled trial.[…]

 

Continue —-> Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial – Jacqui H Morris, Alexandra John, Lucy Wedderburn, Petra Rauchhaus, Peter T Donnan, 2019

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Figure 1. Example of Lycra® gauntlet used in the study.

 

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