Treatment of Shoulder Subluxation in Chronic Stroke Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2001

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Shoulder Dislocation
Interventions
DEVICE

BION stimulation

"The study will have two phases, each with a six week duration. During phase 1, the BION group will be implanted with BIONs in the middle deltoid and supraspinatus muscles. The muscles will be stimulated electrically by way of the BION and an external controller for one to two hours per day at 5pps in an on-off duty cycle train. The SE group will begin surface stimulation similar to that of BE group.~Subjects in either group whose initial therapy in phase 1 successfully reduces the amount of shoulder subluxation to 5mm or less will go off stimulation for six weeks, and be reassessed whether subluxation is redeveloping.~If a subject in either group does not respond sufficiently to phase 1 therapy, the participant will move to phase 2 where the shoulder will be stimulated at up to 25 pps either with surface stimulation (SE group) or BION stimulation (BE group) for another six weeks. At the end of phase 2, participants will go off stimulation for six weeks and then be reevaluated."

Trial Locations (1)

90242

Rancho Los Angeles National Rehabilitation Center, Downey

All Listed Sponsors
lead

University of Southern California

OTHER

NCT00628836 - Treatment of Shoulder Subluxation in Chronic Stroke Patients | Biotech Hunter | Biotech Hunter