Comparison of Sensory Cuing Modalities for Freezing of Gait

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080413
• Other study ID #: 2020-08-025
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: August 28, 2021

Study information

• Verified date: September 2021
• Source: Veterans Health Service Medical Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 28, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Veterans Health Service Medical Center, Seoul, Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Veterans Health Service Medical Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View 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. — View Citation

Barthel C, Nonnekes J, van Helvert M, Haan R, Janssen A, Delval A, Weerdesteyn V, Debû 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. — View 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. Review. — View 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. Review. — View 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. — View 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]. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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