Comparison of Sensory Cuing Modalities for Freezing of Gait

Sponsor
Veterans Health Service Medical Center, Seoul, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT05080413
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The investigators intend to compare the effects on the resolution of visual and auditory sensory cues on the resolution of freezing of gait in patients with idiopathic Parkinson's disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Laser shoes
  • Device: Metronome
N/A

Detailed Description

As Parkinson's disease progresses, the patients develop 'Freezing of gait', which make it difficult to initiate gait, turn at the corner, and enter a narrow space. This is considered to be a very important symptom, as it is related to the performance of daily activities, independence of life, and serious injuries caused by falls while walking in Parkinson's disease patients.

It has been found that the use of external sensory stimulation (visual, auditory) can reduce the symptoms of Freezing of Gait, and is used as rehabilitation treatment and instant symptomatic resolution. However, the relative effectiveness of sensory stimulation is not studied yet.

Accordingly, the investigators intend to compare the effects of visual and auditory sensory cues on the resolution of freezing of gait in patients with idiopathic Parkinson's disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study is a single group pre-post intervention comparison study.This study is a single group pre-post intervention comparison study.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Sensory Cuing Modalities for Freezing of Gait in Patients With Idiopathic Parkinson's Disease : a Pilot Study
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Aug 28, 2021
Actual Study Completion Date :
Aug 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parkinson disease group

A total of 10 patients in this group will walk under the same conditions (off- state of antiparkinson drugs). Participants will be instructed to walk three laps on a 10-meter track under each of the following three conditions : 1) without stimulation, 2) with visual cues using a laser shoe, 3) with auditory cues using a metronome.

Device: Laser shoes
Path Finder® is a device that is fixed to the noses of the patient's shoes using a rubber strap, and laser-marks the place to be stepped on the ground of the opposite foot when walking. It is installed on both feet to relieve the symptoms of freezing of gait.
Other Names:
  • Path Finder®
  • Device: Metronome
    The metronome, which makes a sound with a constant beat, is known to have an effect on the symptoms of Freezing of Gait in Parkinson's disease patients. At a rate of 80 beats per minute, the volume of sound that the patient can fully recognize is set to resolve the freezing of gait using the metronome sound.

    Outcome Measures

    Primary Outcome Measures

    1. Number of freezing of gait episodes [30 minutes]

      The number of occurrences of freezing of gait will be measured in each of the three situations (no sensory stimulation, visual stimulation, and auditory stimulation).

    2. Duration of freezing of gait episodes [30 minutes]

      The average duration per occurrence of freezing of gait in each of the three situations (no sensory stimulation, visual stimulation, and auditory stimulation) will be measured.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Diagnosed with idiopathic Parkinson's disease with freezing of gait according to the United Kingdom (UK) Brain Bank.

    2. Scored more than 15 points of Korean version of mini-mental status exam (K-MMSE).

    3. Independent gait for at least a minute without walking assistance device.

    Exclusion Criteria:
    1. History of concomitant brain disease other than idiopathic Parkinson's disease.

    2. Other neurologically deteriorated states, such as neuromuscular disease, which can cause gait disturbance.

    3. Other psychiatric disorders.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Health Service Medical Center, Seoul, Korea Seoul Korea, Republic of 05368

    Sponsors and Collaborators

    • Veterans Health Service Medical Center, Seoul, Korea

    Investigators

    • Principal Investigator: Jun Yup Kim, M.D., Veterans Health Service Medical Center, Seoul, Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Veterans Health Service Medical Center, Seoul, Korea
    ClinicalTrials.gov Identifier:
    NCT05080413
    Other Study ID Numbers:
    • 2020-08-025
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Veterans Health Service Medical Center, Seoul, Korea
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021