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NCT00037960 · ClinicalTrials.gov registry record · Phase 2
Automated Constraint-Induced Therapy for Restoring Movement After Stroke
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
NCT00037960 is a Phase 2 study that has completed, run by US Department of Veterans Affairs.
The verdict
NCT00037960, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
We propose to develop and evaluate a workstation that significantly enhances the application of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks currently used in the shaping training. The motivation for development of such a device is as follows: 1) Patients could receive CI therapy at home without the need for constant supervision from a therapist. Many veterans do not have the resources to travel to their local VAMC for the two or three week period required for the treatment. A home-based device would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able to receive CI therapy in the clinic, this device would facilitate an effective post-treatment home-practice program. 3) Currently, patients are treated on a one-on-one basis in the clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby substantially reducing the cost of the therapy. 4) This workstation would provide clear and comprehensive quantification of the progress of the treatment. This could indicate on which tasks the patient was progressing most and least rapidly, and would therefore enable effective modifications of the treatment plan while treatment was in progress. The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly enhanced, if the shaping training component is performed in a workstation that guides, motivates and records exercise of the more-affected limb. In the first 18 months, the workstation will be designed and fabricated. To expedite the design, we will rely on simple modifications to "off the shelf" components. In the last 18 months, a controlled, randomized, clinical trial will compare the effectiveness of automated CI therapy programs with standard CI therapy. The standard CI therapy group would receive shaping training in a clinical setting, one-on-one with a therapist. The clinic-based automated CI therapy group would perform the shaping training
Interventions
- PROCEDURE Constrained Induced Therapy
Trial Details
| Field | Value |
|---|---|
| Start Date | 2001-06 |
| Est. Completion | 2004-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00037960
The ClinicalTrials.gov registry entry for NCT00037960 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Constrained Induced Therapy is the first listed.
NCT00037960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00037960 about?
NCT00037960 is a clinical study titled "Automated Constraint-Induced Therapy for Restoring Movement After Stroke". We propose to develop and evaluate a workstation that significantly enhances the application of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks currently used in the shaping training. The motivation for development of such a device is as follows: 1) Patients coul...
What is the current status of trial NCT00037960?
This trial is currently completed. It is a Phase 2 study. The study started on 2001-06. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00037960?
The interventions under investigation include: Constrained Induced Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00037960?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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