Status:
COMPLETED
Treatment of Shoulder Subluxation in Chronic Stroke Patients
Lead Sponsor:
University of Southern California
Conditions:
Shoulder Dislocation
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 s...
Detailed Description
The BION™ is a novel implantable neuromuscular stimulator whose intended use in this study is to reanimate the shoulder muscles of stroke survivors with shoulder subluxation. Strokes are considered to...
Eligibility Criteria
Inclusion
- 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
- Willing to participate and provide informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00628836
Start Date
June 1 2001
End Date
December 1 2008
Last Update
June 3 2015
Active Locations (1)
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1
Rancho Los Angeles National Rehabilitation Center
Downey, California, United States, 90242