The responses from the questionnaires were analysed using chi squared tests. The ratings for treatment effectiveness, treatment worth, and tolerance were dichotomised into < 3 and ≥ 3 for between-group comparisons. The significance level was set at < 0.05. Analyses were conducted separately for the post-intervention and follow-up assessments. Missing data were not imputed. All analyses were performed according to ‘intention-to-treat’. A total of 356 patients were screened; 39 met the eligibility criteria but three declined to participate. Hence 36 were recruited and randomised: 31 (86%) had a stroke and 5 (14%) had a traumatic brain
injury. Table 1 outlines the demographic and neurological characteristics of the two groups. The flow of the participants through the trial is illustrated in Figure 2. Approximately 15 physiotherapists working in the participating KRX-0401 ic50 units administered the electrical stimulation and usual care over the course of the trial. Adherence to the electrical stimulation was excellent and adherence to splinting was fair (Table 2). One participant in the experimental group participated in the program for only two days and then declined further electrical stimulation and splinting. He completed
all the assessments. Five other participants (two in the experimental group and three in the control group) had poor adherence to the splinting regimen (< 50% adherence). Twelve (33%) participants were unexpectedly discharged home before completion of the program, with seven before the post-intervention assessment and another five after the post-intervention assessment selleck kinase inhibitor but before the follow-up assessment (six in the experimental group and six in the control group). In all but three cases, their families and carers were relied upon to continue the interventions. In the three cases that this was not possible, an experienced and trained research assistant visited the participants and provided the interventions according to the study protocol. All primary and secondary outcome measures are shown in Tables 3 and 4 (individual participant data are presented in Table 5 on the eAddenda).
about Both groups showed a mean loss in passive wrist extension over the 4-week intervention period (2 degrees in the experimental group and 9 degrees in the control group). The mean between-group difference at 4 weeks was 7 degrees (95% CI –2 to 15) in favour of the experimental group, which exceeded the pre-determined minimally important level of 5 degrees. However, the 95% CI reflected imprecision around this estimate. At follow-up 2 weeks later, the mean between-group difference was 3 degrees (95% CI –7 to 13) in favour of the control group. There were no convincing treatment effects at 4 or 6 weeks for any of the secondary outcomes although the mean (95% CI) between-group differences of the Global Perceived Effect of Treatment rated by the treating physiotherapists were 1 point (0 to 2) at Week 4 and 3 points (0 to 5) at Week 6.