Biofeedback to Ameliorate Freezing of Gait
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | November 4, 2010 | ||||
| Last Updated Date | December 12, 2010 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of freezing of gait episodes [ Time Frame: 2 hour ] [ Designated as safety issue: No ] Freezing episodes will be counted during lab check. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01259635 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Duration of freezing episodes [ Time Frame: 2 hours ] [ Designated as safety issue: No ] The duraiton of the freezing episodes will be measured. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biofeedback to Ameliorate Freezing of Gait | ||||
| Official Title ICMJE | Biofeedback-based Motor Learning to Ameliorate Freezing of Gait | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
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| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Device: Biofeedback auditory stimulation
Whenever freezing episodes occures, a metronom sound will be heard.
Other Name: Shimmer |
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| Study Arm (s) | Experimental: Bio feedback for freezing
When ever freezing occures, a metronom sound will be heard
Intervention: Device: Biofeedback auditory stimulation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | November 2011 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01259635 | ||||
| Other Study ID Numbers ICMJE | 0510-10-TLV | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nir Giladi MD, Tel Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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