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.
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 language | English |
|---|---|
| Pages (from-to) | 414-422 |
| Number of pages | 9 |
| Journal | Physiotherapy |
| Volume | 103 |
| Issue number | 4 |
| Early online date | 20 Jan 2017 |
| DOIs | |
| Publication status | Published - Dec 2017 |
Keywords
- Stroke rehabilitation
- Dose finding
- Physical therapy
- Upper limb