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Comparison of Sensory Cuing Modalities for Freezing of Gait

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laser shoes
Metronome
Sponsored by
Veterans Health Service Medical Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Freezing of gait, Parkinson Disease, functional near-infrared spectroscopy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Veterans Health Service Medical Center, Seoul, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson disease group

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of freezing of gait episodes
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).
Duration of freezing of gait episodes
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
October 4, 2021
Sponsor
Veterans Health Service Medical Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05080413
Brief Title
Comparison of Sensory Cuing Modalities for Freezing of Gait
Official Title
Comparison of Sensory Cuing Modalities for Freezing of Gait in Patients With Idiopathic Parkinson's Disease : a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
August 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Health Service Medical Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Freezing of gait, Parkinson Disease, functional near-infrared spectroscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a single group pre-post intervention comparison study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson disease group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser shoes
Other Intervention Name(s)
Path Finder®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Metronome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of freezing of gait episodes
Description
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).
Time Frame
30 minutes
Title
Duration of freezing of gait episodes
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with idiopathic Parkinson's disease with freezing of gait according to the United Kingdom (UK) Brain Bank. Scored more than 15 points of Korean version of mini-mental status exam (K-MMSE). Independent gait for at least a minute without walking assistance device. Exclusion Criteria: History of concomitant brain disease other than idiopathic Parkinson's disease. Other neurologically deteriorated states, such as neuromuscular disease, which can cause gait disturbance. Other psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yup Kim, M.D.
Organizational Affiliation
Veterans Health Service Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Health Service Medical Center, Seoul, Korea
City
Seoul
ZIP/Postal Code
05368
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data to other researchers.
Citations:
PubMed Identifier
19095226
Citation
Bartels AL, Leenders KL. Parkinson's disease: the syndrome, the pathogenesis and pathophysiology. Cortex. 2009 Sep;45(8):915-21. doi: 10.1016/j.cortex.2008.11.010. Epub 2008 Nov 27.
Results Reference
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PubMed Identifier
23625316
Citation
Heremans E, Nieuwboer A, Vercruysse S. Freezing of gait in Parkinson's disease: where are we now? Curr Neurol Neurosci Rep. 2013 Jun;13(6):350. doi: 10.1007/s11910-013-0350-7.
Results Reference
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PubMed Identifier
21724402
Citation
Shine JM, Naismith SL, Lewis SJ. The pathophysiological mechanisms underlying freezing of gait in Parkinson's Disease. J Clin Neurosci. 2011 Sep;18(9):1154-7. doi: 10.1016/j.jocn.2011.02.007. Epub 2011 Jul 2.
Results Reference
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PubMed Identifier
32322387
Citation
Gao C, Liu J, Tan Y, Chen S. Freezing of gait in Parkinson's disease: pathophysiology, risk factors and treatments. Transl Neurodegener. 2020 Apr 15;9:12. doi: 10.1186/s40035-020-00191-5. eCollection 2020.
Results Reference
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PubMed Identifier
22157432
Citation
Lee SJ, Yoo JY, Ryu JS, Park HK, Chung SJ. The effects of visual and auditory cues on freezing of gait in patients with Parkinson disease. Am J Phys Med Rehabil. 2012 Jan;91(1):2-11. doi: 10.1097/PHM.0b013e31823c7507. Erratum In: Am J Phys Med Rehabil. 2012 Apr;91(4):345. Park, Hee Kyoung [corrected to Park, Hee Kyung].
Results Reference
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PubMed Identifier
29263221
Citation
Barthel C, Nonnekes J, van Helvert M, Haan R, Janssen A, Delval A, Weerdesteyn V, Debu B, van Wezel R, Bloem BR, Ferraye MU. The laser shoes: A new ambulatory device to alleviate freezing of gait in Parkinson disease. Neurology. 2018 Jan 9;90(2):e164-e171. doi: 10.1212/WNL.0000000000004795. Epub 2017 Dec 20.
Results Reference
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PubMed Identifier
20339591
Citation
Arias P, Cudeiro J. Effect of rhythmic auditory stimulation on gait in Parkinsonian patients with and without freezing of gait. PLoS One. 2010 Mar 22;5(3):e9675. doi: 10.1371/journal.pone.0009675.
Results Reference
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PubMed Identifier
1564476
Citation
Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
Results Reference
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Comparison of Sensory Cuing Modalities for Freezing of Gait

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