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  • Specialised orthotic care to improve functioning in adults with neuromuscular disorders: protocol of a prospective randomised open-label blinded end-point study

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Rehabilitation medicine
Protocol
Specialised orthotic care to improve functioning in adults with neuromuscular disorders: protocol of a prospective randomised open-label blinded end-point study
  1. Elza van Duijnhoven1,
  2. Fieke Sophia Koopman1,
  3. Jana Antonius Maria Tuijtelaars1,
  4. Viola Altmann2,
  5. Rimke Lagrand1,
  6. Johanna Maria van Dongen3,
  7. Frans Nollet1,
  8. Merel-Anne Brehm1
  1. 1Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  2. 2Klimmendaal Rehabilitation Center, Arnhem, The Netherlands
  3. 3Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
  1. Correspondence to Elza van Duijnhoven; e.vanduijnhoven{at}amsterdamumc.nl

Abstract

Introduction People suffering from leg muscle weakness caused by neuromuscular disorders (NMDs) are often provided with leg orthoses to reduce walking problems such as increased walking effort, diminished walking speed, reduced balance and falls. However, evidence for the effectiveness of leg orthoses to improve walking in this patient group is limited and there is an absence of standardised practice in orthotic prescription. In 2012 a Dutch multidisciplinary guideline was developed aimed to standardise the orthotic treatment process in NMD. Although application of the guideline in expert centres (specialised orthotic care) seems beneficial regarding clinical effectiveness, larger studies are necessary to confirm results and investigate cost-effectiveness. Therefore, this study aims to examine the effectiveness and cost-effectiveness of specialised orthotic care compared with usual orthotic care in adults with slowly progressive NMD.

Methods and analysis A prospective randomised open-label blinded end-point study will be performed, in which 70 adults with slowly progressive NMD are randomly assigned to specialised orthotic care (intervention) or usual orthotic care (control). Outcome measures are assessed at baseline and at 3 and 6 months follow-up. The primary endpoints are gross walking energy cost (J/kg/m) assessed during a 6 min walk test and achievement of personal goals, measured with the Goal Attainment Scale. Secondary endpoints include walking speed, gait biomechanics, stability, physical functioning, falls and fear of falling, perceived fatigue and satisfaction. For the economic evaluation, societal costs and health-related quality of life will be assessed using cost questionnaires and the 5-Level version of EuroQol 5 Dimension, retrospectively.

Ethics and dissemination The study is registered in the Dutch trial register (NL 7511) and the protocol has been approved by the Medical Ethics Committee of the Academic Medical Center in Amsterdam. Results will be presented at national and international scientific conferences and disseminated through peer-reviewed journals and media aimed at a broad audience including patients.

  • neuromuscular disease
  • rehabilitation medicine
  • protocols & guidelines
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2020-039683

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    Footnotes

    • Contributors M-AB, FSK and FN conceived the study. M-AB, FSK, FN, JMvD and EvD contributed to the study design and methods. M-AB, FSK, FN, JAMT, RL, VA and EvD participated in logistical planning of the study. EvD wrote the manuscript and is responsible for data acquisition and analysis. All authors conceived, provided feedback and approved the final version of the manuscript.

    • Funding This study was supported by ZonMw, The Netherlands Organisation for Health Research and Development, grant number: 853 001 103.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.