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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 25, 2008 | ||||
| Last Updated Date | October 27, 2008 | ||||
| Start Date ICMJE | April 2004 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale [ Time Frame: baseline, 2 weeks, 4 weeks and 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00628537 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Post-Stroke Hand/Wrist Flexion Deformity | ||||
| Official Title ICMJE | BION Implantable Microstimulator | ||||
| 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 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. |
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| 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 healing period, subjects will come to the testing center so that the examiner can program the exercise patterns. They will be instructed to increase the strength of their muscle contractions as tolerance permits. The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. The intensity, duration and frequency of the exercise program will be modified according to the progress of the participant, so that the strength of the contraction is increased over time. Surface Stimulation Group Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Stimulus parameters will be similar to those reported in earlier successful stimulation studies. The parameters should achieve a tetanic contraction that raises the joint through full range of motion against gravity (graded 3/5) based on the patient's available range of motion, and cycled, typically at 25-35 pps, using stimulus ramps as necessary so that contractions are smoothly graded and comfortable. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation. Control Group with conservative therapy (Range of motion exercises) The research participant is instructed in self-administered, standard range of motion stretching exercises. If the patient is unable to stretch the fingers into extension, a family member or a care-giver will be instructed to assist. They will be instructed to exercise the affected hand twice daily, repeating the exercise a minimum of 15 times in each session for 6 weeks. Control subjects will return to the clinic every two weeks for the first 6 weeks and every 3 weeks during the follow-up period. During these visits, passive range of motion testing will be administered. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hand Deformities | ||||
| Intervention ICMJE | Device: BION stimulation | ||||
| Study Arms / Comparison Groups |
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| Publications * | Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. Review. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 36 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00628537 | ||||
| Responsible Party | Gerald E. Loeb, MD, Alfred E. Mann Institute | ||||
| Study ID Numbers ICMJE | BT4 | ||||
| Study Sponsor ICMJE | University of Southern California | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Southern California | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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