Biofeedback to Ameliorate Freezing of Gait
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Biofeedback auditory stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's disease, freezing of gait
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of PD.
- Suffer from the freezing of gait (FOG) symptoms. Subjects must score 2 or more on item #3 of the subjective FOG questionnaire (FOG-Q) and exhibit two or more FOG episodes during a short, functional FOG evaluation procedure that includes FOG-provoking conditions (e.g., turns, doorways) and 5 laps of walking in a figure 8 shaped trajectory.
- Able to walk unassisted for at least 5 minutes with ample rest.
Exclusion Criteria:
- Having serious co-morbidities or acute illness that would make training inappropriate.
- Have had brain surgery.
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bio feedback for freezing
Arm Description
When ever freezing occures, a metronom sound will be heard
Outcomes
Primary Outcome Measures
Number of freezing of gait episodes
Freezing episodes will be counted during lab check.
Secondary Outcome Measures
Duration of freezing episodes
The duraiton of the freezing episodes will be measured.
Full Information
NCT ID
NCT01259635
First Posted
November 4, 2010
Last Updated
December 12, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01259635
Brief Title
Biofeedback to Ameliorate Freezing of Gait
Official Title
Biofeedback-based Motor Learning to Ameliorate Freezing of Gait
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.
Detailed Description
The freezing burden will be quantified in subjects with PD before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.
We anticipate that after intensive training, the central nervous system (CNS) of subjects with PD will be able to anticipate impending freezing episodes based on awareness of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious response to a deteriorating gait pattern. As a result, an automated motor response that paces and coordinates gait will be internally triggered by the CNS and the approaching freezing episode will be averted. The overall freezing burden will therefore decrease in trained subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, freezing of gait
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bio feedback for freezing
Arm Type
Experimental
Arm Description
When ever freezing occures, a metronom sound will be heard
Intervention Type
Device
Intervention Name(s)
Biofeedback auditory stimulation
Other Intervention Name(s)
Shimmer
Intervention Description
Whenever freezing episodes occures, a metronom sound will be heard.
Primary Outcome Measure Information:
Title
Number of freezing of gait episodes
Description
Freezing episodes will be counted during lab check.
Time Frame
2 hour
Secondary Outcome Measure Information:
Title
Duration of freezing episodes
Description
The duraiton of the freezing episodes will be measured.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of PD.
Suffer from the freezing of gait (FOG) symptoms. Subjects must score 2 or more on item #3 of the subjective FOG questionnaire (FOG-Q) and exhibit two or more FOG episodes during a short, functional FOG evaluation procedure that includes FOG-provoking conditions (e.g., turns, doorways) and 5 laps of walking in a figure 8 shaped trajectory.
Able to walk unassisted for at least 5 minutes with ample rest.
Exclusion Criteria:
Having serious co-morbidities or acute illness that would make training inappropriate.
Have had brain surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nir Giladi, MD
Phone
+972-3-6974790
Ext
1
Email
ngiladi@tasmc.healht.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, MD
Phone
+972-3-6974790
Ext
1
Email
ngiladi@tasmc.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Biofeedback to Ameliorate Freezing of Gait
We'll reach out to this number within 24 hrs