Dataset Information

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.

SUBMITTER: Morris JH

PROVIDER: S-EPMC6613174 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Morris Jacqui H JH John Alexandra A Wedderburn Lucy L Rauchhaus Petra P Donnan Peter T PT

Clinical rehabilitation 20190412 8

<h4>Objective</h4>The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra<sup>®</sup> orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes.<h4>Design</h4>This is a single-blind, two-arm parallel group, feasibility randomized controlled trial.<h4>Setting</h4>In-patient rehabilitation.<h4>Subjects</h4>The study participants were stroke survivors with arm hemiparesis t ...[more]

PMID: 30977382

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Dataset Information

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

Objective

Design

Setting

Subjects

Interventions

Main measures

Results

Conclusion

Publications

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

Similar Datasets

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