Clinical trial NCT05131906: Laser Shoes for Freezing in People With Parkinson's Disease
Official title: Assessing the Use of Lasers on Shoes for Freezing of Gait in People With Parkinson's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of gait
laser shoes
Parkinson's disease
External cueing
Parkinsonian Disorder
Movement Disorders
Neurodegenerative Diseases
Freezing
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: FY2020 Research Bridge
name: Arizona State University
First posted: 2021-11-23
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of the visual cues of a wearable device in preventing freezing of gait (FOG) in those with PD.The aim is to investigate the impact of laser shoe attachments on gait in single and dual-tasking scenarios, as well as "real-world" mobility scenarios, in people with PD who freeze. For this study, participants will wear sensors on their feet, hips, chest, and head to show stride length, foot angle, and foot height, and head position during different gait assessments. The patients will do the gait assessments without the laser shoes and with the laser shoes to determine how the laser shoes affect freezing of gait. The gait assessments include having the patient complete a two minute walk, two minute walk with another task (reciting every other letter of the alphabet), obstacle course, obstacle course with another task (reciting every other letter of the alphabet), and quickly turning in place. The assessments are activities that are performed in everyday activities so there are no risks associated with these requested tasks. These activities will be done in a lab at the Phoenix Biomedical Campus. Safety for the participants will be monitored by placing a belt around the waist of the participant with a member of the research personnel close by in case the participant demonstrated a shift in their balance. The research member can use the belt to provide stability and secure the participant, preventing them from further loss of balance. Moreover, three different activities of daily living (ADL's) will be assessed with and without the laser shoes in a simulated apartment environment located at the Phoenix Biomedical campus. The ADL's include walking from the bed to the kitchen, walking from the living room to the kitchen and making tea in the microwave, and answering the door. The activities to be done in the apartment setting will be video-recorded and analyzed. Some participants will be given the laser shoes to take home and use for one week. The same protocol explained above will be used to assess freezing of gait after this one week in those selected participants. To assess retention of improvements, the participants who took the laser shoes home will also be given the same protocol two days later (after not having used the laser shoes during that time). Participants will also complete surveys for quality of life, freezing and gait and cognitive function. A standard test for balance will also be conducted.

Detailed description: 15 individuals with Parkinson's Disease will complete two tasks: a gait task and an activity of daily living (ADL) task both with and without the use of laser shoe attachment. The gait task involves 5 separate scenarios: 2 min walk with a single and dual-task trial, obstacle course with a single and dual-task trial, and a quick turn-in-place. For the dual-task trials, participants will complete the 2 min walk and obstacle course scenarios in addition to a cognitive task (e.g. reciting the alphabet every other letter). During the single-task trials for the 2 min walk and obstacle course, participants will complete these activities without a cognitive task. Participants will also be required to fill out surveys for quality of life, balance and freezing of gait. A standard test for balance will be conducted (MiniBEST). Participants will be assessed using the UPDRS in order to categorize the level of Parkinson's Disease. Permission and training for use of the UPDRS will be obtained prior to testing participants.

The ADL task involves three "real-world" mobility scenarios, in which participants will be asked to: walk from the bedroom to the bathroom and also the kitchen, make tea in the kitchen, and move from the couch to answer the front door.

For both tasks, gait will be characterized during each scenario using inertial sensors (OPALs). Outcomes will include step length, foot angle and foot height (clearance from floor) and head movement. To characterize functional movements we will video movements during all scenarios for both tasks. Outcomes will be the number and temporal length of each freezing event, to be determined by a movement disorders neurologist.

A subset of participants (n=3) will use the sensors at home for 1 week, and return to the lab for gait and functional task assessment. They will return after a 2-day washout (no sensors) to assess retention of improvements from the 1-week exposure.

Eligibility criteria: Inclusion Criteria:

* People with PD who exhibit freezing, on medications

Exclusion Criteria:

* People who are non-ambulatory

Primary outcomes:
measure: Freezing Severity
timeFrame: 4 hours
Secondary outcomes:
measure: Freezing of Gait Ratio
timeFrame: This outcome will be assessed during in-place turning with and without laser shoes (both collected within the same data collection). The time frame will be 2 hours with or without the lasers followed by 2 hours without or with the lasers.
Other outcomes:
measure: Step length during gait
timeFrame: 4 hours
measure: Foot angle during gait
timeFrame: 4 hours
measure: Foot height during gait
timeFrame: 4 hours
Locations:
city: Phoenix
country: United States
facility: Phoenix Biomedical Campus
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Cindy C Ivy, OTD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang L, Xu W, Li Z, Chen Y, Chen H, Yu R, Zhu X, Gu D. Quantitative gait analysis for laser cue in Parkinson's disease patients with freezing of gait. Ann Transl Med. 2019 Jul;7(14):324. doi: 10.21037/atm.2019.05.87.
citation: Sejdic E, Fu Y, Pak A, Fairley JA, Chau T. The effects of rhythmic sensory cues on the temporal dynamics of human gait. PLoS One. 2012;7(8):e43104. doi: 10.1371/journal.pone.0043104. Epub 2012 Aug 21.
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.
citation: Ferraye MU, Fraix V, Pollak P, Bloem BR, Debu B. The laser-shoe: A new form of continuous ambulatory cueing for patients with Parkinson's disease. Parkinsonism Relat Disord. 2016 Aug;29:127-8. doi: 10.1016/j.parkreldis.2016.05.004. Epub 2016 May 6. No abstract available.