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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00819949
First received: January 7, 2009
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Device: Lokomat
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Freezing of Gait [ Time Frame: Each Visit ] [ Designated as safety issue: No ]
    Temporary halting of gait


Estimated Enrollment: 20
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Potential eligible subjects for the trial will be individuals between ages 18-85, with a confirmed diagnosis of PD that experience freezing.
Device: Lokomat
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs through position controlled trajectories that mimic normal human gait patterns. This is accomplished by utilizing high quality computer-controlled motors that are precisely synchronized with the speed of the treadmill. The hip and knee joint angles are controlled in real time by software to achieve kinematically correct stepping behaviors. Each of the four motor-driven joints is individually controlled to correspond precisely to the desired joint angle trajectories. This system assures a precise match between the speed of the limb trajectory and the treadmill. In addition, sensors in the motors provide an indirect indicator of the amount of effort the patient is generating to achieve walking in an upright posture.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819949

Locations
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799
Sponsors and Collaborators
Investigators
Principal Investigator: Albert Lo, MD PhD Providence VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00819949     History of Changes
Other Study ID Numbers: B4125-K
Study First Received: January 7, 2009
Last Updated: September 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Robot
Treadmill
Rehabilitation
Freezing of gait

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 26, 2014