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Completed Phase 2 Interventional

Automated Constraint-Induced Therapy for Restoring Movement After Stroke

ClinicalTrials.gov ID: NCT00037960

Public ClinicalTrials.gov record NCT00037960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 in the workstation, in a clinical setting and with minimal supervision. The home-based automated CI therapy group would perform the shaping training at home in the workstation, and with no direct supervision. All other aspects of the three treatment programs will be identical. At the end of this 3-year project, a device will have been designed, built and evaluated that could significantly enhance the application of CI therapy for chronic stroke patients.

Study identification

NCT ID
NCT00037960
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
Not listed

Conditions and interventions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2001
Primary completion
Not listed
Completion
May 31, 2004
Last update posted
Jan 20, 2009

2001 – 2004

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
VA Medical Center Palo Alto California — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00037960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 20, 2009 · Synced Sep 26, 2026

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