Biofeedback to Ameliorate Freezing of Gait
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Device: Biofeedback auditory stimulation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | Biofeedback-based Motor Learning to Ameliorate Freezing of Gait |
- Number of freezing of gait episodes [ Time Frame: 2 hour ] [ Designated as safety issue: No ]Freezing episodes will be counted during lab check.
- Duration of freezing episodes [ Time Frame: 2 hours ] [ Designated as safety issue: No ]The duraiton of the freezing episodes will be measured.
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bio feedback for freezing
When ever freezing occures, a metronom sound will be heard
|
Device: Biofeedback auditory stimulation
Whenever freezing episodes occures, a metronom sound will be heard.
Other Name: Shimmer
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Nir Giladi, MD | +972-3-6974790 ext 1 | ngiladi@tasmc.healht.gov.il |
| Israel | |
| Tel Aviv Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Nir Giladi, MD +972-3-6974790 ext 1 ngiladi@tasmc.health.gov.il | |
| Principal Investigator: | Nir Giladi, MD | Tel-Aviv Sourasky Medical Center |
More Information
No publications provided
| Responsible Party: | Nir Giladi MD, Tel Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01259635 History of Changes |
| Other Study ID Numbers: | 0510-10-TLV |
| Study First Received: | November 4, 2010 |
| Last Updated: | December 12, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Parkinson's disease 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 May 19, 2013