Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jan;44(1):3-14.
doi: 10.1097/NPT.0000000000000295.

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial

Irene Aprile  1 , Marco Germanotta, Arianna Cruciani, Simona Loreti, Cristiano Pecchioli, Francesca Cecchi, Angelo Montesano, Silvia Galeri, Manuela Diverio, Catuscia Falsini, Gabriele Speranza, Emanuele Langone, Dionysia Papadopoulou, Luca Padua, Maria Chiara Carrozza; FDG Robotic Rehabilitation Group
Affiliations
Randomized Controlled Trial

Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial

Irene Aprile et al. J Neurol Phys Ther. 2020 Jan.

Abstract

Background and purpose: After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy.

Methods: In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation.

Results: One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference -0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences.

Discussion and conclusions: Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).

Trial registration: ClinicalTrials.gov NCT02879279.

PubMed Disclaimer

References

    1. Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003;34(9):2181–2186.
    1. Gowland C. Recovery of motor function following stroke: profile and predictors. Physiother Canada. 1982;34(2):77–84. doi:10.3138/ptc.34.2.077.
    1. Kwakkel G, Wagenaar RC, Kollen BJ, Lankhorst GJ. Predicting disability in stroke—a critical review of the literature. Age Ageing. 1996;25(6):479–489.
    1. Feys HM, De Weerdt WJ, Selz BE, et al. Effect of a therapeutic intervention for the hemiplegic upper limb in the acute phase after stroke: a single-blind, randomized, controlled multicenter trial. Stroke. 1998;29(4):785–792.
    1. Broeks JG, Lankhorst GJ, Rumping K, Prevo AJ. The long-term outcome of arm function after stroke: results of a follow-up study. Disabil Rehabil. 1999;21(8):357–364.

Publication types

Associated data