The REAcH project. A Randomised Controlled Trial of an Accelerometer Triggered Functional Electrica Stimulation Device For Recovery of Upper Limb Function in Chronic Stroke Patients. Paul Taylor The National Clinical FES Centre Salisbury UK BACKGROUND Cyclic exercise stimulation of wrist, finger and thumb flexors has been shown to improve function but generally the improvement has not bean maintained at least in chronic CVA (Pandyan et al. 997) FES for dropped foot has a long term training effect (Taylor et al. 999 &, Kottink et al. 4) There is strong and growing evidence that relearning of function is encouraged by appropriate functional practice of meaningful tasks, aimed at acquiring a practical skill rather than simple repetition of a movement (Krakauer et al. 5) Reciprocal Inhibition Sensory Input Boosted by Electrical Stimulation Extensors Flexors Hebbian Learning and Rushton s Hypothesis Hebbian Learning and Rushton s Hypothesis Nerves that fire together w ire together F w ave F w ave When tw o adjacent neurons are active they are more likely to make synaptic connections
Training Orthosis for practicing reaching and obtaining objects Target group Ability to make a grip but unable to release Restricted elbow extension Chronic stroke Stimulation Wrist, finger and thumb extensors Triceps Stimulation triggered by movement sensor Assistance to reach and open the hand in response to attempt to make movement Feasibility Study Repeated Case Study design 8 months 5 participants 4 week baseline weeks exercise stimulation elbow, wrist & finger extension weeks triggered stimulation for given functional tasks, use of system for practice of chosen ADL tasks & any other ADL desired by the participant Treatment withdrawn at end of this period week follow up 8 7 6 5 4 6 5 4 Action Research Arm Test (ARAT) (max. possible score 57) MICD MICD 6 Wek-4 Wek Wek Wek6 Wek Wek4 Canadian Occupational Performance M easure (COPM ) - performance (p) & satisfaction (s) scores p w k p w k p w k 4 s wk s wk s wk 4 Mean Modified Ashworth Score - - -.5.5.5 elbow -4 elbow elbow elbow 6 elbow elbow 4 Elb ow, w rist an d fing er fl exor spasticity wrist -4 wrist wrist wrist 6 wrist wrist 4 fingers -4 fingers fingers fingers 6 fingers fingers 4 Elbow, Wrist and Fingers MAS at -4,,, 6, and 4 Psychosocial Impact of Assistive Devices (PIADS) competence adaptability self esteem range = - to +, =no change ± 9 5% Co nfidence USER REPORTS At end of study one volunteer made her husband a birthday cake - something she had not attempted since her stroke. She w as also able to fasten the buttons on her jeans w ithout help. A nd volunteer w as able to hold his large camera steady w ith both hands giving him more control over the standard of his photographs, regain use of the controls on his car w ith his affected arm and hold a book and turn the pages w hen singing in his choir w ithout needing a music stand. Most users found the stimulation system easy to don and doff and the controls easy to use. All users reported reduced muscle stiffness in the hemiplegic arm All users reported increased aw areness of their hemiplegic arm w hich encouraged them at least to use it for handed tasks. All users found the system useful and w ould recommend it to others The trigger w as not alw ays effective and some participants at times used the system in exercise mode to assist w ith functional activities as w ell as during the prescribed exercise sessions. RCT The REAcH Project (Re-Education of Arm and Hand) The same protocol except: per group (6 in total) powered on ARAT Control group who performed the same exercises without FES assistance Base line 6 weeks not 4 weeks Blinded assessments Triceps stim combined with anterior deltoid Stimulator re-engineered to make set up easier Stimulator set up by Physio not Engineer Additional outcome measures Fugl Meyer impairment Stroke Impact Scale QOL Box and block hand function Salisbury and University of Salford
6 Recruited ARAT Exercise group FES group 9 completed protocol completed protocol Age 56.9 Time since stroke 5 months male 9 female 9 right left hemi 9 same hand dominance as stroke Age 6. (p=.) Time since stroke 4 months (p=.47) 4 male 8 female 8 right left hemi 7 same hand dominance as stroke Exercise group: Improved ARAT but mean below MICD FES group: No Training effect. MICD w hen device sw itched on No significant difference between groups Box and Block Fugl Meyer Total Score MICD 5. Exercise group: Small Improvement in B&B at week 4 FES group: No Training effect. No improvement when device switched on No significant difference between groups Both groups showed reduced impairment There w as no difference betw een groups SIS Physical Problems SIS Hand Function MICD 9. Both groups show ed improved physical scores Both groups show ed improved hand function scores
SIS Quality of Life SIS Stroke Recovery # The exercise groups showed improved QoL scores at week Both groups showed improved stroke recovery scores This w as greater in the FES group at w eek 4 COMP Performance MICD. COMP Satisfaction Both groups improved COPM satisfaction and performance scores There w as no statistical difference between groups E lbow W ris t Fingers # E lbow W ris t Fingers Modified Ashworth Score The exercise group show ed small but statistically significant improvements in MAS This w as statistically significantly different at w eek 4 for fingers The FES did not change FES user feedback Use of Device Questionnaire (n=4) 8 reported benefit from the device reported increased voluntary movement 6 reduced spastic tone 4 increased awareness of their effect upper limb increased use of their effective upper limb in bimanual tasks 9 reported or more improved ADL task 8 participants rated the device effective and very effective. FES user feedback Use of Device Questionnaire (n=4) Device used: mean of days in the last weeks of trial used a median of 85 minutes each day had difficulty correctly positioning the device and electrodes. 7 reported that the controls were difficult to use 8 experienced device failure, reporting that this was frequent 6 reported the device was very useful, 6 useful, 6 fairly useful and 6 not useful for performing practical tasks. would like to continue using the device, 5 would not. 4
Conclusions There was no significant difference between groups in almost all outcome measures Changes were significantly less than in the pilot study Participants reported benefits from the device Improvements in device reliability are required ACKNOWLEDGEMENTS The participants for taking part Laurence Kenney Geraldine Mann Chris Smith Julie Esnouf Helen Lucky Carol McFadden Karen Waring In the Pilot study, ARAT score correlated w ith the finger MAS score at week There w as no similar correlation in the RCT No difference in Starting ARAT Age Time since stroke There was a difference in mean Wrist MAS (.7 pilot,.8 RCT) Finger MAS (.4 pilot,.8 RCT) 5