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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: Completed Phase 1 study, sponsored by US Department of Veterans Affairs.
NCT00819949 is a Phase 1 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Temporary halting of gait
Interventions
- DEVICE Lokomat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00819949 record still lists
NCT00819949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Lokomat is the first listed.
NCT00819949 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00819949's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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