Treatment of Shoulder Subluxation in Chronic Stroke Patients (NCT00628836) | Clinical Trial Compass
CompletedPhase 1
Treatment of Shoulder Subluxation in Chronic Stroke Patients
United States30 participantsStarted 2001-06
Plain-language summary
The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It compares electrical stimulation with surface electrodes (stimulation through the skin) with intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION® group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2 sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy. If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more intense therapy is carried out for another 6 weeks. Treatment is similar in the surface electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of 30 subjects is expected to complete the study.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosis of hemiplegic stroke at least 6 months prior to enrollment;
✓. Paresis of the shoulder muscles;
✓. Shoulder subluxation (i.e., a positive sulcus sign of 5 mm or more);
✓. Age 18 years or older;
✓. Stable use of pain medication for at least one month prior to enrollment;
✓. Medically stable;
✓. Able to travel to the testing center;
✓. Mentally capable to understand and carry out the procedures and communicate concerns; and
Exclusion criteria
✕. Pregnant, nursing, or planning to become pregnant within the next four months;