Comparison of Sensory Cuing Modalities for Freezing of Gait

NCT05080413 | Completed DMC

• 1 other identifier: 2020-08-025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Freezing of gait; Parkinson Disease; functional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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).

  30 minutes

• 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.

  30 minutes

Study Arms (1)

Parkinson disease group

EXPERIMENTAL

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; Device: Metronome

Interventions

Laser shoes DEVICE

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.

Also known as: Path Finder®

Parkinson disease group

Metronome DEVICE

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.

Parkinson disease group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veterans Health Service Medical Center, Seoul, Korea: lead

Study Sites (1)

Veterans Health Service Medical Center, Seoul, Korea

Seoul, 05368, South Korea

Location

Related Publications (9)

• 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.

  PMID: 19095226 BACKGROUND

• 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.

  PMID: 23625316 BACKGROUND

• 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.

  PMID: 21724402 BACKGROUND

• 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.

  PMID: 32322387 BACKGROUND

• 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.

  PMID: 22157432 BACKGROUND

• 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.

  PMID: 29263221 BACKGROUND

• 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.

  PMID: 20339591 BACKGROUND

• 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.

  PMID: 1564476 BACKGROUND

• An EJ, Sim WS, Kim SM, Kim JY. Suitability of visual cues for freezing of gait in patients with idiopathic Parkinson's disease: a case-control pilot study. J Neuroeng Rehabil. 2023 Jul 18;20(1):91. doi: 10.1186/s12984-023-01214-8.

  PMID: 37464390 DERIVED

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

• Jun Yup Kim, M.D.

  Veterans Health Service Medical Center, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single group pre-post intervention comparison study.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 15, 2021
• Study Start: October 15, 2020
• Primary Completion: August 28, 2021
• Study Completion: August 28, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)