A Randomised Controlled Trial of an Accelerometer Triggered Functional Electrical Stimulation Device For Recovery of Upper Limb Function in Chronic Stroke – The REAcH project. Paul Taylor1, Geraldine Mann1, Julie Esnouf1, Helen Luckie2, Karen Waring2, Carol McFadden2, Christine Smith2, Laurence Kenney2. 1 National Clinical FES Centre, Dept. Clinical Sciences and Engineering, Salisbury NHS Foundation Trust, Salisbury, SP2 8BJ 2 Centre for Health Sciences, University of Salford, Greater Manchester, M6 6PU Objective To evaluate Functional Electrical Stimulation (FES) device, designed to facilitate hand opening and elbow extension. MICD = 6 ARAT Box and Block The REAcH Stimulator A movement sensor in the stimulator is used to measure the angle of the upper arm to vertical. Stimulation is triggered by passing a pre-set angle. Hence the user can voluntary initiate FES to assist shoulder flexion, elbow extension and hand opening. Channel 1: One electrode on the triceps, the other on anterior deltoid Channel 2: Posterior interosseous nerve – forearm extensors 60 Recruited Methods Following a 6-week baseline, participants were randomly allocated to either an FES and exercise or exercise only groups. The FES group participated at home in 2 weeks of cyclic stimulation then movement -triggered stimulation for a further 10 weeks. Both groups practised functional tasks and were assessed at week’s -6, 0, 12 and 24, 12 weeks after the interventions ended. Fugl Meyer Total Score SIS Physical Problems Exercise group 31 FES group 29 22 completed protocol 22 completed protocol Results There was a statistically significant increase in total Action Research Arm Test (ARAT) scores in the exercise group at 12 weeks, which was maintained at week 24. No significant change was seen in the FES group except with FES turned on and there was no significant difference in the change in scores between groups. Both groups showed significant improvement in impairment level by Fugl-Meyer (FM) test at 12 weeks, but there was no significance between groups. A small but statistically significant improvement was measured in both groups using the Canadian Occupational Performance Measure, no difference between groups. Both groups received similar improvements in quality of life score. User satisfaction was overall positive but reports of difficulties suggest device improvements are needed to make it adequately reliable and more user friendly. Age 56.9 Time since stroke 52 months 13 male 9 female 9 right 13 left hemi 9 same hand dominance as stroke Age 63.3 (p=0.11) Time since stroke 42 months (p=0.47) 14 male 8 female 8 right 12 left hemi 7 same hand dominance as stroke SIS Hand Function SIS Quality of Life MICD = 2.0 SIS Stroke Recovery Conclusion There were no significant differences between the groups in almost all outcome measures, changes were significantly less than in the pilot study1. Participants did report benefits from the device, however improvements in the reliability of the device are required. Acknowledgments The REAcH Project was funded by the Stroke Association * Within group significant change from base line (Wilcoxon) # Between group significant difference (Mann Whitney U Test) Red line is the minimum important clinical difference (MICD) Bar = median, box = inter-quartile range, whisker = 95% of data, red crosses = full range of data Reference 1. Mann G, Taylor P, Lane R. Accelerometer-Triggered Electrical Stimulation for Reach and Grasp in Chronic Stroke Patients: A Pilot Study. Neurorehabil Neural Repair May 31, 2011 1545968310397200