Prevention of Post-Stroke Hand/Wrist Flexion Deformity

Completed · Phase 1

Conditions studied: Hand Deformities

In brief

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 position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.

Key facts

Study ID

NCT00628537

Run by

University of Southern California

People needed

30

Starts

2004-04-01

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 qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Rancho Los Angeles National Rehabilitation Center — Downey, California, United States

Full record on ClinicalTrials.gov

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