Biofeedback to Ameliorate Freezing of Gait

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01259635
First received: November 4, 2010
Last updated: December 12, 2010
Last verified: December 2010

November 4, 2010
December 12, 2010
January 2011
November 2011   (final data collection date for primary outcome measure)
Number of freezing of gait episodes [ Time Frame: 2 hour ] [ Designated as safety issue: No ]
Freezing episodes will be counted during lab check.
Same as current
Complete list of historical versions of study NCT01259635 on ClinicalTrials.gov Archive Site
Duration of freezing episodes [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
The duraiton of the freezing episodes will be measured.
Same as current
Not Provided
Not Provided
 
Biofeedback to Ameliorate Freezing of Gait
Biofeedback-based Motor Learning to Ameliorate Freezing of Gait

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Parkinson's Disease
Device: Biofeedback auditory stimulation
Whenever freezing episodes occures, a metronom sound will be heard.
Other Name: Shimmer
Experimental: Bio feedback for freezing
When ever freezing occures, a metronom sound will be heard
Intervention: Device: Biofeedback auditory stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have a diagnosis of PD.
  2. 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.
  3. Able to walk unassisted for at least 5 minutes with ample rest.

Exclusion Criteria:

  1. Having serious co-morbidities or acute illness that would make training inappropriate.
  2. Have had brain surgery.
Both
40 Years to 85 Years
No
Contact: Nir Giladi, MD +972-3-6974790 ext 1 ngiladi@tasmc.healht.gov.il
Israel
 
NCT01259635
0510-10-TLV
No
Nir Giladi MD, Tel Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Nir Giladi, MD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP