Biofeedback to Ameliorate Freezing of Gait

NCT01259635 | Unknown

• 1 other identifier: 0510-10-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; freezing of gait

Outcome Measures

Primary Outcomes (1)

• Number of freezing of gait episodes

  Freezing episodes will be counted during lab check.

  2 hour

Secondary Outcomes (1)

• Duration of freezing episodes

  2 hours

Study Arms (1)

Bio feedback for freezing

EXPERIMENTAL

When ever freezing occures, a metronom sound will be heard

Device: Biofeedback auditory stimulation

Interventions

Biofeedback auditory stimulation DEVICE

Whenever freezing episodes occures, a metronom sound will be heard.

Also known as: Shimmer

Bio feedback for freezing

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Having serious co-morbidities or acute illness that would make training inappropriate.
• Have had brain surgery.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

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

Study Officials

• Nir Giladi, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Giladi, MD

CONTACT

+972-3-6974790; ngiladi@tasmc.healht.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 14, 2010

Record last verified: 2010-12

Locations

IL (1)