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NCT00819949 · ClinicalTrials.gov registry record · Phase 1

Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease

A Phase 1 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00819949 is a Phase 1 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants.

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The verdict

NCT00819949, a Phase 1 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

Freezing of gait (FOG) is a common yet poorly understood motor symptom in persons with Parkinson's disease (PD). Previous studies have shown that bilateral uncoordinated gait and gait asymmetry are related to FOG, and that intensive treadmill training in PD patients can improve gait. However, no group has yet studied the effect of robot-assisted gait training (RAGT) on FOG. The primary aim of this study is to collect pilot data on the effect of robot-assisted gait training in reducing episodes of freezing in PD. Subjects with Parkinson's disease that experience freezing of gait will be recruited and enrolled following informed consent and screening for eligibility. Each of the 10 training session will last approximately one hour. Neurological evaluations, testing of gait parameters, and quality of life assessments will be conducted. Participants will also be asked to return for 1- and 3-month post-intervention assessments to see if the training has any lasting effects. Approximately 10-20 subjects will be enrolled, and the study will last up to 6 months. Robot-assisted gait training will be conducted with the Lokomat (a treadmill with supplemental robot-assistance for moving the hip and knee). We will monitor changes in freezing by conducting various assessments. There are approximately 1 million Americans with PD in the US. PD is a significant cause for reduced functional ability and quality of life, progressive disability. Patients with PD with FOG have indicated that this is one of their most disturbing symptoms, as there are no effective treatments. Therefore it is important that additional and alternative interventions for FOG be tested and developed.

Interventions

  • DEVICE Lokomat

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2008-10
Est. Completion 2010-10
Phase Phase 1

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00819949

The ClinicalTrials.gov registry entry for NCT00819949 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Lokomat is the first listed.

NCT00819949 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00819949 about?

NCT00819949 is a clinical study titled "Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease". Freezing of gait (FOG) is a common yet poorly understood motor symptom in persons with Parkinson's disease (PD). Previous studies have shown that bilateral uncoordinated gait and gait asymmetry are related to FOG, and that intensive treadmill training in PD patients can improve gait. However, no gro...

What is the current status of trial NCT00819949?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-10. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00819949?

The interventions under investigation include: Lokomat (DEVICE).

Who is sponsoring clinical trial NCT00819949?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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