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Title: Dose in stroke rehabilitation trials
Author: Colucci, Elisabetta
ISNI:       0000 0004 6059 8710
Awarding Body: University of East Anglia
Current Institution: University of East Anglia
Date of Award: 2016
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Background: the dose and the length of rehabilitative interventions for optimal motor recovery after stroke are unknown. Dose optimization studies are required as precursors to efficacy trials, but are rarely conducted in stroke rehabilitation research. Objective: to overcome the knowledge gap on appropriate dose and length of rehabilitative interventions guiding the implementation of novel effective approaches to dose optimization in stroke rehabilitation research. Method: two systematic reviews on dose optimization in exercise-based training and pharmaceutical clinical research guided the development of a new approach to dose-finding suitable for physical interventions. The feasibility of a novel phase I 3+3 rule-based, outcome-adaptive dose-finding design was assessed with stroke survivors with moderate upper limb paresis. Moreover, the feasibility of a repetitive assessment procedure to identify the appropriate length of motor interventions was explored in stroke rehabilitation research. Results: the first literature review showed a lack of reliable approaches to dose optimization in exercise-based training. The review of pharmaceutical research highlighted dose optimization “gold” standard approaches, and helped in devising the dose-finding study for physical intervention. The dose-finding study was feasible using the applied model-task intervention. Preliminary explorations on the dose-response relationship were possible indicating a maximum tolerable dose and a potential recommended dose of 209 and 162 repetitions respectively of the applied intervention-task. The repetitive assessment procedure was found feasible in a clinical efficacy stroke rehabilitative trial. The repetitive assessment procedure provided relevant data on the therapy effect over-time showing that more than six weeks of the applied upper limb intervention may be necessary to reach maximal therapy effects. Whereas, five weeks of intervention appeared enough to exploit therapy effects for the lower limb. Conclusions: results are promising on identifying relevant dose and protocol endpoints implementing dose-finding and repetitive assessments approaches in stroke rehabilitation. Further confirmative data are needed to validate these findings.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available