Status:
COMPLETED
Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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 re...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic PD by UK Brain Bank criteria, without other significant neurological problems.
- Men and women between the ages of 18-85 years.
- History of FOG by self-report and verified by MD.
- Must be able to walk unassisted when not freezing but use of a device to prevent falls and overcome freezing is not exclusionary. (Device should not be used for visual cueing).
Exclusion
- Cognitively unable to understand instructions required by the study.
- Presence of medical or neurological infirmity that might contribute to significant gait dysfunction (such as severe OA, foot drop, sensory neuropathy, blindness, joint replacement, etc.), determined by the physician during the screening exam.
- Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg.
- History of uncontrolled diabetes.
- Significant symptoms of orthostasis when standing up.
- Circulatory problems, history of vascular claudication or 3+ pitting edema.
- Body weight over 100 kg.
- Lower extremity injuries that limit range of motion or function.
- Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
- Unstable fractures.
- Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
- Chronic and ongoing alcohol or drug abuse.
- Active depression, anxiety or psychosis that might interfere with use of the equipment or testing.
- Inability to participate in and complete the training sessions.
- Patients determined to have an atypical parkinsonian syndrome by a neurologist.
- Patients with PD that have undergone deep brain stimulation.
- Primarily wheelchair bound.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00819949
Start Date
October 1 2008
End Date
October 1 2010
Last Update
September 20 2013
Active Locations (1)
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1
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799