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

Elisabetta Colucci, Allan Clark, Catherine E. Lang, Valerie M. Pomeroy

Research output: Contribution to journalArticle

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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.
Original languageEnglish
Pages (from-to)414-422
Number of pages9
JournalPhysiotherapy
Volume103
Issue number4
Early online date20 Jan 2017
DOIs
Publication statusPublished - Dec 2017

Keywords

  • Stroke rehabilitation
  • Dose finding
  • Physical therapy
  • Upper limb

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