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.
Article Info
No comments:
Post a Comment