Treatment of Shoulder Subluxation in Chronic Stroke Patients
Completed · Phase 1
Conditions studied: Shoulder Dislocation
In brief
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.
Key facts
- Study ID
- NCT00628836
- Run by
- University of Southern California
- People needed
- 30
- Starts
- 2001-06-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2015-06-03
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant, nursing, or planning to become pregnant within the next four months;
- Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.);
- Presence of metallic implants in the immediate field of the magnetic coil:
- Use of using electrical stimulation for treatment of their subluxed shoulder in the past month;
- Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue;
- Presence of other unrelated shoulder problems;
- Severe hemineglect ( patient is unable to acknowledge or answer questions about the involved limb)
- Cancer or other serious illness, including a disease other then stroke resulting in dysfunction of movement.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention to the upper limb.
Where it is running
- Rancho Los Angeles National Rehabilitation Center — Downey, California, United States
Full record on ClinicalTrials.gov
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