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Author Spotlight: Rehabilitation of Stroke Patients With a Digital Occupational Training System

Author Spotlight: Rehabilitation of Stroke Patients With a Digital Occupational Training System

Published on: December 29, 2023

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

E Colucci¹, A Clark², C E Lang³

¹Acquired Brain Injury Rehabilitation Alliance, School of Health Sciences, University of East Anglia, Norwich, UK.

|August 14, 2017

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 preset 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 preset increment/decrease and checking rules were then applied to set the dose for the subsequent cohort. The process was repeated until preset stopping rules were met.

Participants:

Participants had a mean age of 68 (range 48 to 81) years, and were a mean of 70 (range 9 to 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 preset 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.

Keywords:

Dose finding Physical therapy Stroke rehabilitation Upper limb

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