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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:10/14/2017
Start Date:October 2008
End Date:October 2010

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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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
Providence, Rhode Island 02908
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from
Providence, RI
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