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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lokomat
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Robot, Treadmill, Rehabilitation, Freezing of gait

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Providence VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Potential eligible subjects for the trial will be individuals between ages 18-85, with a confirmed diagnosis of PD that experience freezing.

Outcomes

Primary Outcome Measures

Freezing of Gait
Temporary halting of gait

Secondary Outcome Measures

Full Information

First Posted
January 7, 2009
Last Updated
September 18, 2013
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00819949
Brief Title
Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease
Official Title
Effect of Robot-assisted Gait Training on Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Robot, Treadmill, Rehabilitation, Freezing of gait

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Potential eligible subjects for the trial will be individuals between ages 18-85, with a confirmed diagnosis of PD that experience freezing.
Intervention Type
Device
Intervention Name(s)
Lokomat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freezing of Gait
Description
Temporary halting of gait
Time Frame
Each Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lo, MD PhD
Organizational Affiliation
Providence VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4799
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20946640
Citation
Lo AC, Chang VC, Gianfrancesco MA, Friedman JH, Patterson TS, Benedicto DF. Reduction of freezing of gait in Parkinson's disease by repetitive robot-assisted treadmill training: a pilot study. J Neuroeng Rehabil. 2010 Oct 14;7:51. doi: 10.1186/1743-0003-7-51.
Results Reference
result

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

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