FAST INdICATE Trial
Clinical Efficacy of FunctionAl STrength TraINing for upper limb motor recovery early after stroke: neural CorrelATEs and prognostic indicators (FAST INdICATE).
Weakness of the arm and hand after stroke affects everyday lives. People with substantial weakness may not be able to participate in proven treatment which requires repeated practice of functional tasks such as pouring water from a jug. The present study will investigate two forms of conventional therapy (CPT). One is called Functional Strength Training (FST). The other is called Movement Performance Therapy (MPT). Both are used but we do not know which stroke survivors will respond best to which therapy.
This is a two group randomised clinical trial in three clinical centres. All 288 participants will receive their conventional physiotherapy (CPT). In addition they will be randomised to receive extra treatment either as MPT or FST. The measures of clinical outcome that will be used to compare the effects of the two extra therapies will be: the ability to use the weaker arm and hand for functional tasks such as picking up a pencil; and the ability to produce voluntary contraction of weak muscles against resistance. These measures will be made before treatment begins, after 6 weeks of treatment and at 6 months after the stroke.
The trial is designed to find whether the benefits of FST justify a subsequent large scale trial. Embedded in the trial are measures to increase understanding of how central nervous system (CNS) recovers in response to MPT and FST after stroke. We know that CNS recovery involves reorganisation of nerve networks in the brain and spinal cord. We do not yet know how to use MPT and FST to encourage beneficial reorganisation to improve outcomes after stroke.
To answer these questions we will combine: brain imaging and magnetic brain stimulation to find out how the biological mechanisms underpinning arm use change over time in the two groups of participants and whether these changes are associated with improvements in the ability to perform everyday tasks.
This research was funded/supported by the National Institute for Health Research (NIHR).