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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.