Comparison of Sensory Cuing Modalities for Freezing of Gait

October 4, 2021 updated by: Veterans Health Service Medical Center, Seoul, Korea

Comparison of Sensory Cuing Modalities for Freezing of Gait in Patients With Idiopathic Parkinson's Disease : a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05368
        • Veterans Health Service Medical Center, Seoul, Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of freezing of gait episodes
Time Frame: 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).
30 minutes
Duration of freezing of gait episodes
Time Frame: 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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Health Service Medical Center, Seoul, Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

August 28, 2021

Study Completion (Actual)

August 28, 2021

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-08-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual participant data to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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