A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development

Colucci, Elisabetta, Clark, Allan, Lang, Catherine E. and Pomeroy, Valerie M. (2017) A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development. Physiotherapy, 103 (4). pp. 414-422. ISSN 0031-9406

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    Abstract

    Background: Dose-optimisation studies as precursors to clinical trials are rare in stroke rehabilitation. Objective: To develop a rule-based, dose-finding design for stroke rehabilitation research. Design: 3 + 3 rule-based, dose-finding study. Dose escalation/de-escalation was undertaken according to pre-set rules and a mathematical sequence (modified Fibonacci sequence). The target starting daily dose was 50 repetitions for the first cohort. Adherence was recorded by an electronic counter. At the end of the 2-week training period, the adherence record indicated dose tolerability (adherence to target dose) and the outcome measure indicated dose benefit (10% increase in motor function). The pre-set increment/decrease and checking rules were then applied to set the dose for the subsequent cohort. The process was repeated until pre-set stopping rules were met. Participants: Participants had a mean age of 68 (range 48–81) years, and were a mean of 70 (range 9–289) months post stroke with moderate upper limb paresis. Model task: A custom-built model of exercise-based training to enhance ability to open the paretic hand. Outcome measure: Repetitions per minute of extension/flexion of paretic digits against resistance. Analysis: Usability of the pre-set rules and whether the maximally tolerated dose was identifiable. Results: Five cohorts of three participants were involved. Discernibly different doses were set for each subsequent cohort (i.e. 50, 100, 167, 251 and 209 repetitions/day). The maximally tolerated dose for the model training task was 209 repetitions/day. Conclusions: This dose-finding design is a feasible method for use in stroke rehabilitation research.

    Item Type: Article
    Uncontrolled Keywords: stroke rehabilitation,dose finding,physical therapy,upper limb
    Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
    Faculty of Medicine and Health Sciences > Norwich Medical School
    Depositing User: Pure Connector
    Date Deposited: 27 Jan 2017 02:11
    Last Modified: 23 Jan 2019 12:50
    URI: https://ueaeprints.uea.ac.uk/id/eprint/62202
    DOI: 10.1016/j.physio.2016.10.393

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