The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
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|ClinicalTrials.gov Identifier: NCT00762814|
Recruitment Status : Terminated (There was no funding for the device to be used in the study.)
First Posted : September 30, 2008
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Parkinson subjects with freezing
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.
Device: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)
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.
- Timed Up and Go [ Time Frame: Time of study visit ]
- Time to perform a 360 degree turn while standing in place [ Time Frame: Time of study visit ]
- Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject [ Time Frame: Time of study visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762814
|United States, Missouri|
|Washington University Program in Physical Therapy|
|Saint Louis, Missouri, United States, 63108|