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 (Lead / Corresponding author), Alexandra John, Lucy Wedderburn, Petra Rauchhaus, Peter T. Donnan

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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.

Original languageEnglish
Pages (from-to)1331-1343
Number of pages13
JournalClinical Rehabilitation
Volume33
Issue number8
Early online date12 Apr 2019
DOIs
Publication statusPublished - 1 Aug 2019

Fingerprint

Splints
Rehabilitation
Randomized Controlled Trials
Health Services Research
Stroke
Odds Ratio
Confidence Intervals
Orthotic Devices
Paresis
Survivors
Motor Activity
Interviews
Control Groups
Stroke Rehabilitation

Keywords

  • Arm
  • orthotic device
  • rehabilitation
  • stroke

Cite this

@article{e635fc5a82bf42cfa7eb768ddcda405f,
title = "Dynamic Lycra{\circledR} 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{\circledR} 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{\circledR} 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.",
keywords = "Arm, orthotic device, rehabilitation, stroke",
author = "Morris, {Jacqui H.} and Alexandra John and Lucy Wedderburn and Petra Rauchhaus and Donnan, {Peter T.}",
note = "The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by the Chief Scientist Office at the Scottish Government (grant no. CZH/4/1075).",
year = "2019",
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TY - JOUR

T1 - Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke

T2 - a single-blind, two-arm parallel group, randomized controlled feasibility trial

AU - Morris, Jacqui H.

AU - John, Alexandra

AU - Wedderburn, Lucy

AU - Rauchhaus, Petra

AU - Donnan, Peter T.

N1 - The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by the Chief Scientist Office at the Scottish Government (grant no. CZH/4/1075).

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

AB - 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.

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KW - orthotic device

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KW - stroke

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DO - 10.1177/0269215519840403

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SN - 0269-2155

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