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Reporting of “usual care” as the control group in randomized clinical trials of physiotherapy interventions for multiple sclerosis is poor: a systematic review

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Abstract

Objective

To compare the description of interventions defined as “usual care” in control groups with those provided in experimental groups in physiotherapy randomized clinical trials for multiple sclerosis.

Methods

Two independent reviewers conducted a literature search and study selection from five databases from their inception to February 2021. Randomized clinical trials aimed to physiotherapy multiple sclerosis treatment and providing “usual care” in the control group were included. Intervention reporting was assessed using the TIDieR checklist. Word and reference counts for each group were extracted. The methodological quality was assessed by the PEDro scale.

Results

Twenty-four articles were included. The TIDieR total scores, word, and reference count were statistically higher in the experimental group, when compared to the control group (p < 0.001). The TIDieR total score is not correlated with PEDro score, word, publication year, or reference counts.

Conclusion

Control treatments identified as “usual care” are underdescribed when compared to experimental treatments, affecting the validity, generalizability, and interpretability of results.

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Authors and Affiliations

  1. Unit of Functional Rehabilitation, Azienda USL Toscana Centro, Viale Michelangiolo, 41, 50125, Florence, Italy

    Matteo Paci

  2. School of Physiotherapy, University of Florence, Florence, Italy

    Federico Risaliti

  3. IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

    Leonardo Pellicciari

Authors
  1. Matteo Paci
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  2. Federico Risaliti
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  3. Leonardo Pellicciari
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Contributions

M. P. and F. R. were primarily responsible for study conception and design and for data analysis and interpretation. All authors (M. P., F. R., L. P.) participated in the phases of the systematic review. M. P. analyzed the data. All authors (M. P., F. R., L. P.) interpreted the results. M. P. led the writing of the first draft of the manuscript. All authors (M. P., F. R., L..P.) contributed to drafting and revising the manuscript. M. P. is the guarantor. All authors (M. P., F. R., L. P.) read and approved the final manuscript.

Corresponding author

Correspondence to Matteo Paci.

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Appendix 1 References of the articles included in the systematic review

Appendix 1 References of the articles included in the systematic review

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    Dodd KJ, Taylor NF, Shields N, Prasad D, McDonald E, Gillon A. Progressive resistance training did not improve walking but can improve muscle performance, quality of life and fatigue in adults with multiple sclerosis: a randomized controlled trial. Mult Scler. 2011;17:1362–74. https://doi.org/10.1177/1352458511409084.

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    Schwartz I, Sajin A, Moreh E, Fisher I, Neeb M, Forest A, Vaknin-Dembinsky A, Karusis D, Meiner Z. Robot-assisted gait training in multiple sclerosis patients: a randomized trial. Mult Scler. 2012;18:881–90. https://doi.org/10.1177/1352458511431075.

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    Gutiérrez RO, Galán Del Río F, Cano de la Cuerda R, Alguacil Diego IM, González RA, Page JC. A telerehabilitation program by virtual reality-video games improves balance and postural control in multiple sclerosis patients. NeuroRehabilitation. 2013;33:545–54. https://doi.org/10.3233/NRE-130995.

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    Keser I, Kirdi N, Meric A, Kurne AT, Karabudak R. Comparing routine neurorehabilitation program with trunk exercises based on Bobath concept in multiple sclerosis: pilot study. J Rehabil Res Dev. 2013;50:133–40. https://doi.org/10.1682/jrrd.2011.12.0231.

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    Ortiz-Gutiérrez R, Cano-de-la-Cuerda R, Galán-del-Río F, Alguacil-Diego IM, Palacios-Ceña D, Miangolarra-Page JC. A telerehabilitation program improves postural control in multiple sclerosis patients: a Spanish preliminary study. Int J Environ Res Public Health. 2013;10:5697–710. https://doi.org/10.3390/ijerph10115697.

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    Straudi S, Benedetti MG, Venturini E, Manca M, Foti C, Basaglia N. Does robot-assisted gait training ameliorate gait abnormalities in multiple sclerosis? A pilot randomized-control trial. NeuroRehabilitation. 2013;33:555–63. https://doi.org/10.3233/NRE-130990.

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    Skjerbæk AG, Næsby M, Lützen K, Møller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014;20:627–30. https://doi.org/10.1177/1352458513505351.

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    Brichetto G, Piccardo E, Pedullà L, Battaglia MA, Tacchino A. Tailored balance exercises on people with multiple sclerosis: a pilot randomized, controlled study. Mult Scler. 2015;21:1055–63. https://doi.org/10.1177/1352458514557985.

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    Feys P, Coninx K, Kerkhofs L, De Weyer T, Truyens V, Maris A, Lamers I. Robot-supported upper limb training in a virtual learning environment: a pilot randomized controlled trial in persons with MS. J Neuroeng Rehabil. 2015;12:60. https://doi.org/10.1186/s12984-015-0043-3.

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    Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: a randomized, controlled trial. Mult Scler. 2015;21:1453–62. https://doi.org/10.1177/1352458514562438.

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    Hansen D, Wens I, Keytsman C, Verboven K, Dendale P, Eijnde BO. Ventilatory function during exercise in multiple sclerosis and impact of training intervention: cross-sectional and randomized controlled trial. Eur J Phys Rehabil Med. 2015;51:557–68.

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    Straudi S, Fanciullacci C, Martinuzzi C, Pavarelli C, Rossi B, Chisari C, Basaglia N. The effects of robot-assisted gait training in progressive multiple sclerosis: a randomized controlled trial. Mult Scler. 2016;22:373–84. https://doi.org/10.1177/1352458515620933.

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    Fox EE, Hough AD, Creanor S, Gear M, Freeman JA. Effects of pilates-based core stability training in ambulant people with multiple sclerosis: multicenter, assessor-blinded, randomized controlled trial. Phys Ther. 2016;96:1170–8. https://doi.org/10.2522/ptj.20150166.

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    Kalron A, Fonkatz I, Frid L, Baransi H, Achiron A. The effect of balance training on postural control in people with multiple sclerosis using the CAREN virtual reality system: a pilot randomized controlled trial. J Neuroeng Rehabil. 2016;13:13. https://doi.org/10.1186/s12984-016-0124-y.

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    Hugos CL, Bourdette D, Chen Y, Chen Z, Cameron M. A group-delivered self-management program reduces spasticity in people with multiple sclerosis: a randomized, controlled pilot trial. Mult Scler J Exp Transl Clin. 2017;3:2055217317699993. https://doi.org/10.1177/2055217317699993.

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    Kalron A, Rosenblum U, Frid L, Achiron A. Pilates exercise training vs. physical therapy for improving walking and balance in people with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2017;31:319–328. https://doi.org/10.1177/0269215516637202.

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    Toomey E, Coote S. Augmenting home exercise programmes in multiple sclerosis with “exercise buddies”: a pilot study. International Journal of Therapy and Rehabilitation 2017;24;54–61.

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    Arntzen EC, Straume BK, Odeh F, Feys P, Zanaboni P, Normann B. Group-based individualized comprehensive core stability intervention improves balance in persons with multiple sclerosis: a randomized controlled trial. Phys Ther. 2019 Aug 1;99(8):1027–1038. https://doi.org/10.1093/ptj/pzz017.

  20. 20.

    Cuesta-Gómez A, Sánchez-Herrera-Baeza P, Oña-Simbaña ED, Martínez-Medina A, Ortiz-Comino C, Balaguer-Bernaldo-de-Quirós C, Jardón-Huete A, Cano-de-la-Cuerda R. Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial. J Neuroeng Rehabil. 2020 Jul 13;17(1):90. https://doi.org/10.1186/s12984-020-00718-x.

  21. 21.

    Ozdogar AT, Ertekin O, Kahraman T, Yigit P, Ozakbas S. Effect of video-based exergaming on arm and cognitive function in persons with multiple sclerosis: a randomized controlled trial. Mult Scler Relat Disord. 2020 May;40:101966. https://doi.org/10.1016/j.msard.2020.101966.

  22. 22.

    Ryan JM, Fortune J, Stennett A, Kilbride C, Lavelle G, Hendrie W, DeSouza L, Abdul M, Brewin D, David L, Anokye N, Victor C, Norris M. Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: results from the iStep-MS randomised controlled trial. Mult Scler. 2020 Dec;26(14):1907–1918. https://doi.org/10.1177/1352458519886231.

  23. 23.

    Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): a randomized controlled trial. Mult Scler. 2020 May;26(6):716–724. https://doi.org/10.1177/1352458519833901.

  24. 24.

    Ziliotto N, Lamberti N, Manfredini F, Straudi S, Baroni M, Tisato V, Carantoni M, Secchiero P, Basaglia N, Marchetti G, Bernardi F. Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors. Mult Scler Relat Disord. 2020 Sep;44:102319. https://doi.org/10.1016/j.msard.2020.102319.

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Paci, M., Risaliti, F. & Pellicciari, L. Reporting of “usual care” as the control group in randomized clinical trials of physiotherapy interventions for multiple sclerosis is poor: a systematic review. Neurol Sci 43, 5207–5216 (2022). https://doi.org/10.1007/s10072-022-06167-9

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