Biofeedback-based Motor Learning to Ameliorate Freezing of Gait

NCT01223781 | Unknown DMC

• 1 other identifier: 510-10-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective/Rationale: The investigators objective is to demonstrate that an intervention program based on motor learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer from freezing to walk in a way that minimizes the occurrence of freezing. Since sufficient motor learning capabilities are preserved in PD, the investigators hypothesize that an intervention program that targets the time periods just prior to an approaching freezing episode can modify the walking strategies so that the episode will now be averted. Project 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. Relevance to Diagnosis/Treatment of Parkinson's Disease: If even partially successful, the investigators will show, for the first time that freezing of gait is amenable to motor learning and that appropriate training with external cueing can alleviate these motor blockades. While future studies will be needed to further assess long-term efficacy and other important questions about clinical efficacy and the mechanisms involved, this study should go a long way towards improving the investigators understanding of freezing of gait and its amenability to appropriate therapy. Anticipated Outcome: The investigators 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.

Conditions

Gait; Parkinson Disease

Keywords

Freezing; biofeedback; motor learning; freezing of gait in PD

Outcome Measures

Primary Outcomes (1)

• Number of freezing episodes

  In lab examinaiton and then in 3 days of ambulatory monitoring, the nubmer of freezing episodes will be counted before and after the intervention.

  3 days

Secondary Outcomes (1)

• duration of freezing episodes

  3 days

Study Arms (2)

Feedforward stimulation

EXPERIMENTAL

Prior to any gait condition likely to invoke freez, auditory stimulation is presented

Behavioral: Biofeedback-based motor learning for PD

Feedback stimulation

EXPERIMENTAL

Once a device identifies freezing, a auditory stimulation is triggered

Behavioral: Biofeedback-based motor learning for PD

Interventions

Biofeedback-based motor learning for PD BEHAVIORAL

Prior to freezing episodes, auditory stimulation is triggered

Feedback stimulation; Feedforward stimulation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) Unable to walk unassisted for at least 5 minutes with ample rest. 2)Brain surgery.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.

  PMID: 19906597 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Meir Plotnik, PhD

CONTACT

972 326974958; meirp@tasmc.health.gov.il

Jeffrey M Hausdorff, PhD

CONTACT

972 326974958; jhausdor@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 17, 2010
• First Posted: October 19, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

IL (1)