Comparison of Sensory Cuing Modalities for Freezing of Gait

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Laser shoes; Device: Metronome

• Registration Number: NCT05080413
• Lead Sponsor: Veterans Health Service Medical Center, Seoul, Korea

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.

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2021-08-28
• Study Completion: 2021-08-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parkinson disease group	Laser shoes	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.
Parkinson disease group	Metronome	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.

Primary Outcome Measures

Name	Time	Method
Number of freezing of gait episodes	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	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.

Trial Locations

Locations (1)

Veterans Health Service Medical Center, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of