Description of Event or Problem · 1
THIS PT WITH CEREBRAL PALSY IS THE FIRST TO ENROLLED IN A STUDY TO ASSESS THE BENEFITS OF SURFACE ELECTRICAL STIMULATION TO IMPROVE WALKING. WATER BASED ELECTRODES WERE USED TO CONDUCT THE CURRENT FROM THE STIMULATOR TO THE SKIN WHICH CAUSED HER PLANTAR FLEXOR AND DORSIFLEXOR MUSCLES TO CONTRACT AT THE CORRECT TIME TO MOVE THE LEG PROPERLY FOR WALKING EFFICIENCY. THE STIMULATION WAS PROVIDED THROUGHOUT THE DAY (6-8 HRS) WHENEVER THE CHILD WAS WALKING AND TURNED OFF AUTOMATICALLY WHEN THE CHILD WAS INACTIVE. THE CHILD HAD BEEN WEARING THE STIMULATION SYSTEM FOR 3 WEEKS WHEN SHE CAME FOR HER WEEKLY MONITORING ACCORDING TO THE STUDY PROTOCOL. A SKIN RASH DEVELOPED UNDER BOTH PADS STIMULATING THE PLANTAR FLEXOR MUSCLES. THE PADS WERE REMOVED AND STIMULATION WAS DISCONTINUED. THE PRINCIPAL INVESTIGATOR PHOTOGRAPHED THE LEG AND NOTIFIED THE IRB OF THIS EVENT. THE IRB COMMITTEE DETERMINED THE CHILD SHOULD BE REMOVED FROM THE STUDY. EVENTUALLY, THE STUDY WAS SUSPENDED DUE TO A TOTAL OF 4 CHILDREN WHO DEVELOPED A SIMILAR SKIN IRRITATION. THE RASH BEGAN TO IMPROVE ONCE THE PADS WERE REMOVED AND THE STIMULATION WAS DISCONTINUED. WITHIN 10 DAYS, THE SKIN RETURNED TO A HEALTHY COLOR. THE REDNESS RESOLVED WITHIN 5 WEEKS. DATES OF USE: (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: HEMIPLEGIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. FACILITY: (B)(6).