Status:
COMPLETED
Prevention of Post-Stroke Hand/Wrist Flexion Deformity
Lead Sponsor:
University of Southern California
Conditions:
Hand Deformities
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that ...
Detailed Description
BION™ Experimental Group Following implantation, the patients receiving BIONs will have a 3 to 7 day healing period. During this period, subjects will not receive active therapy. At the end of this h...
Eligibility Criteria
Inclusion
- Diagnosis of hemiplegic stroke 6 months to 20 years prior to enrollment in this study;
- Paresis of extensors in the forearm;
- Demonstrable restriction of hand or wrist mobility (i.e. significant stretch response, defined as a 2+ or greater on the Ashworth scale, can be elicited in the finger or wrist flexor muscles, and the patient's resting hand posture is flexed when the patient is standing with the upper arm pendant and the elbow flexed);
- Age 18 years or older;
- Stable pattern of pain-medication use 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
- Able and willing to participate and provide informed consent.
- Ability to bring the wrist into neutral posture and the MCP joints into 30 degrees of flexion
Exclusion
- Pregnant, nursing, or planning to become pregnant within the study timeframe;
- Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.);
- Presence of metallic implants, such as artificial elbow implants or metal screws, in the immediate field of the magnetic coil (on the arm between the fingers and the shoulder).
- Use of electrical stimulation for treatment of relevant extensor muscles in the past month;
- Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue;
- Presence of other unrelated hand or wrist pathologies; participating in other treatments including active physical therapy or drug therapy that affect their hand or wrist.
- Severe hemineglect; and
- Cancer or other serious illness, including a disease other than stroke resulting in motor dysfunction.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00628537
Start Date
April 1 2004
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