Physiotherapy Coupled With Dextroamphetamine for Rehabilitation After Hemiparetic Stroke

Abstract

Background and Purpose-Hemiparesis is the commonest disabling deficit caused by stroke. In animals, dextroamphetamine (AMPH) paired with training enhances motor recovery, but its clinical efficacy is uncertain. Methods-In a randomized, double-blind, placebo-controlled trial, 71 stroke patients were stratified by hemiparesis severity and randomly assigned to 10 sessions of physiotherapy coupled with either 10 mg AMPH or placebo. Study treatments were administered by 1 physiotherapist, beginning 5 to 10 days after stroke and continuing twice per week for 5 weeks. Outcomes were assessed by 1 physiotherapist at baseline, after each treatment session, at 6 weeks, and at 3 months. The primary outcome was motor recovery (impairment level) on the Fugl-Meyer (FM) scale. Secondary outcomes assessed mobility, ambulation, arm/hand function, and independence in activities of daily living.

Amphetamine increases blood pressure and heart rate but has no effect on motor recovery or cerebral haemodynamics in ischaemic stroke: a randomized controlled trial (ISRCTN 36285333)

“…First, enrolment in this study was terminated early because of a low recruitment rate (a problem seen in other trials with limiting inclusion criteria 24,46 ), so the intended sample size was not achieved thereby leading to a potential type II error when viewed in the context of the pretrial sample size calculation. This problem was compounded by the heterogeneous nature of recruited patients with widely varying impairment at baseline.…”

“…In keeping with this, many of the outcome measures utilized demonstrate ceiling effects, although some studies have excluded patients with mild weakness in an attempt to overcome this. 17,21,24,27 Amphetamine increases blood pressure not recovery N Sprigg et al regimes might have been tested; the regime utilized here (and pioneered by others 17,23,24,26,35,36 ) was driven by concern for potential adverse effects. It is possible that higher and more frequent doses are required, as tested in experimental models.…”

“…Dexamphetamine sulphate (initial 5 mg dose followed by 10 mg thereafter) or placebo was administered orally twice a week with alternating 3-or 4-day separations. 17,23,24,26,35,36 The dose of 10 mg is unlikely to cause dependency or extreme vascular instability. There were a total of 11 doses covering a treatment period of 35 days.…”

“…5,9,10 However, timing and dose of administration appears important; high doses and early administration being associated with a poor outcome, 5,11 whereas pretreatment with amphetamine led to increased ischaemic insult. 12 The evidence in normal subjects [13][14][15] and in clinical stroke is less clear, [16][17][18][19][20][21][22][23][24][25][26][27] numerous small trials, utilising varying dosage and timing of treatment, showing conflicting results, overall demonstrating no evidence of benefit on motor recovery. Although treatment appears feasible and well tolerated, a trend towards increased death in the treatment group exists on meta-anlaysis.…”

Stroke, with or with no ice? Observations on amphetamine for the management of acute stroke

“…In contrast, patients with moderate severity hemiparesis exhibited significant limb motor recovery, but limited to the upper extremity. 22 While these observations suggest that stroke patients with mild motor deficits are more responsive to D-amphetamine effects, another clinical study proved this hypothesis wrong, in that the trial was halted when the interim efficacy analysis of 26 stroke patients with mild arm paresis revealed lack of motor facilitation or motor recovery with D-amphetamine over placebo at immediate post-training or long-term periods. 23 In this issue of the Journal of Human Hypertension, the new study Bath et al 24 corroborates recent reports that amphetamine has limited therapeutic effects for improving stroke outcome.…”