Back to resultsThe Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Individuals, frequent, freezing, during, gait
Eligibility Criteria
Inclusion Criteria:
- PD diagnostic criteria include those used for clinically defined "definite PD", as previously outlined22 based upon established criteria.22, 23
- history of consistent freezing with ambulation in a straight line and/or when turning.
- normal central and peripheral neurological function
- at least grade 4 strength and normal joint ranges of motion in both legs
- normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa.
- Each must have had clear benefit from levodopa for at least some of his/her PD symptoms
- All subjects with PD must be able to walk independently for 10 feet.
Exclusion Criteria:
- serious medical problem that would impair the ability to undergo testing.
- use of neuroleptic or other dopamine-blocking drug
- use of drugs that might affect balance
- history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
- participants who are unable to provide informed consent
Sites / Locations
- Washington University Program in Physical Therapy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parkinson subjects with freezing
Arm Description
Each subject will have been diagnosed with Parkinson disease and will serve as his/her own control. Inclusion criteria: history of consistent freezing with ambulation in a straight line and/or when turning, normal central and peripheral neurological function, at least grade 4 strength and normal joint ranges of motion in both legs, normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa, each must have had clear benefit from levodopa for at least some of his/her PD symptoms, and all subjects with PD must be able to walk independently for 10 feet. Exclusion criteria include: serious medical problem that would impair the ability to undergo testing, use of neuroleptic or other dopamine-blocking drug, use of drugs that might affect balance, history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease, or participants who are unable to provide informed consent.
Outcomes
Primary Outcome Measures
Timed Up and Go
Secondary Outcome Measures
Time to perform a 360 degree turn while standing in place
Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject
Full Information
NCT ID
NCT00762814
First Posted
September 23, 2008
Last Updated
May 4, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00762814
Brief Title
The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
Official Title
The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
There was no funding for the device to be used in the study.
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Some individuals with Parkinson disease experience "freezing" during walking which results in their inability to move their feet. They often have difficulty starting to move once they have stopped. Freezing often results in loss of balance and falling. Oral medications for Parkinson disease aren't as effective in treating freezing as it is in reducing other symptoms. Another treatment for freezing is instruction in walking using visual targets or auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some individuals, but the effects do not last. Other types of cues have not been studied. We want to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on the effects of freezing.
Detailed Description
We will use a device (TENS unit) that provides electrical stimulation to a nerve in the lower legs. Electrodes will be placed on the skin of your lower legs and a box that delivers electrical current will cause a tingling feeling in the legs. Subjects will be asked to perform three gait tasks with the device on and off to compare the effects of the sensory cue on the speed/time to complete gait tasks and the frequency and duration of any freezing events. This use of the device (TENS unit) is investigational. While it has been approved by the Food and Drug Administration for the treatment of pain, it has not been approved for the treatment of freezing. Because the TENS unit can provide a sensory cue, it may help to prevent or reduce freezing. If it is found that this cue works, it could lead to new treatments for the treatment of freezing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Individuals, frequent, freezing, during, gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson subjects with freezing
Arm Type
Experimental
Arm Description
Each subject will have been diagnosed with Parkinson disease and will serve as his/her own control. Inclusion criteria: history of consistent freezing with ambulation in a straight line and/or when turning, normal central and peripheral neurological function, at least grade 4 strength and normal joint ranges of motion in both legs, normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa, each must have had clear benefit from levodopa for at least some of his/her PD symptoms, and all subjects with PD must be able to walk independently for 10 feet.
Exclusion criteria include: serious medical problem that would impair the ability to undergo testing, use of neuroleptic or other dopamine-blocking drug, use of drugs that might affect balance, history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease, or participants who are unable to provide informed consent.
Intervention Type
Device
Intervention Name(s)
Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)
Intervention Description
Eligible subjects will be perform walking tests involving the use of the TENS device (Select Unit by Empi) on the lower leg bilaterally during gait: uncued (wearing the unit but, but with the device turned off) or with a tactile cue (wearing the device with it turned on until a tactile stimulus is felt). The TENS unit is a battery-operated, single-channel electrical stimulator worn around the proximal calf that can used to provide a constant tactile stimulus. All subjects will undergo a single visit in which the two walking conditions are tested. During these visits, the patient will perform the same gait assessments measured with the device turned off as well as turned on. Testing the two conditions on the same day/time will provide the investigators with a consistent comparison of the two tested conditions, as mobility and function in patients with PD can vary significantly within and between days.
Primary Outcome Measure Information:
Title
Timed Up and Go
Time Frame
Time of study visit
Secondary Outcome Measure Information:
Title
Time to perform a 360 degree turn while standing in place
Time Frame
Time of study visit
Title
Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject
Time Frame
Time of study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PD diagnostic criteria include those used for clinically defined "definite PD", as previously outlined22 based upon established criteria.22, 23
history of consistent freezing with ambulation in a straight line and/or when turning.
normal central and peripheral neurological function
at least grade 4 strength and normal joint ranges of motion in both legs
normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa.
Each must have had clear benefit from levodopa for at least some of his/her PD symptoms
All subjects with PD must be able to walk independently for 10 feet.
Exclusion Criteria:
serious medical problem that would impair the ability to undergo testing.
use of neuroleptic or other dopamine-blocking drug
use of drugs that might affect balance
history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
participants who are unable to provide informed consent
Facility Information:
Facility Name
Washington University Program in Physical Therapy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
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The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
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