Parkinson DiseaseNCT05080413
Comparison of Sensory Cuing Modalities for Freezing of Gait
A study testing Laser shoes and Metronome in people with Parkinson Disease, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Laser shoes and Metronome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2020to 28 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Veterans Health Service Medical Center, Seoul, Korea
Seoul, 05368
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Laser shoes, Metronome
- Keywords
- Freezing of gait, Parkinson Disease, functional near-infrared spectroscopy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser shoesDevice
Also called Path Finder®
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.
MetronomeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser shoes; Device: Metronome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Oct 2020
- Primary completion28 Aug 2021
- Study completion28 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single group pre-post intervention comparison study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Yup Kim, M.D., Principal investigator, Veterans Health Service Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080413
- Sponsor's protocol ID
- 2020-08-025
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers.
Publications
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.
PubMed 19095226Heremans 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.
PubMed 23625316Shine 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.
PubMed 21724402Gao 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.
PubMed 32322387Lee 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.
PubMed 22157432Barthel 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.
PubMed 29263221Arias 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.
PubMed 20339591Hughes 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.
PubMed 1564476An 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.
PubMed 37464390
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensory Cuing Modalities for Freezing of Gait in Patients With Idiopathic Parkinson's Disease : a Pilot Study
- ClinicalTrials.gov ID
- NCT05080413
- Acronym / sponsor ID
- 2020-08-025
- Conditions
- Parkinson Disease
- Keywords
- Freezing of gait, Parkinson Disease, functional near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Veterans Health Service Medical Center, Seoul, KoreaUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 28 Aug 2021 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single group pre-post intervention comparison study.
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease group | Experimental | Device: Laser shoes, Device: MetronomeA 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser shoesAlso: Path Finder®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. | Device | Parkinson disease group |
| MetronomeThe 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. | Device | Parkinson disease group |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 19095226Bartels 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.
- Background: PubMed 23625316Heremans 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.
- Background: PubMed 21724402Shine 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.
- Background: PubMed 32322387Gao 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.
- Background: PubMed 22157432Lee 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.
- Background: PubMed 29263221Barthel 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.
- Background: PubMed 20339591Arias 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.
- Background: PubMed 1564476Hughes 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.
- Derived from this study: PubMed 37464390An 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Yup Kim, M.D. principal investigator
Veterans Health Service Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser shoes and Metronome in people with Parkinson Disease, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of freezing of gait episodes (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080413, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.