Laser Shoes for Freezing in People With Parkinson's Disease

NCT05131906 | Unknown DMC

• 1 other identifier: 1550436-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Freezing of gait; laser shoes; Parkinson's disease; External cueing; Parkinsonian Disorder; Movement Disorders; Neurodegenerative Diseases; Freezing

Outcome Measures

Primary Outcomes (1)

• Freezing Severity

  The severity of freezing during a gait task, as quantified by review of a video of the movement, assessed by a trained reviewer

  4 hours

Secondary Outcomes (1)

• Freezing of Gait Ratio

  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 (3)

• Step length during gait

  4 hours

• Foot angle during gait

  4 hours

• Foot height during gait

  4 hours

Study Arms (1)

People with Parkinson's disease on medication who freeze

EXPERIMENTAL

We will be testing each of the 15 participants both with and without the removeable lasers on their shoes.

Device: gait task and activity of daily living task

Interventions

gait task and activity of daily living task DEVICE

use of lasers on shoes to potentially minimize freezing of gait

Also known as: A gait task and activity of daily living task without laser shoe attachment

People with Parkinson's disease on medication who freeze

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People with PD who exhibit freezing, on medications

You may not qualify if:

• People who are non-ambulatory

Sponsors & Collaborators

• Northern Arizona University: lead
• FY2020 Research Bridge: collaborator
• Arizona State University: collaborator

Study Sites (1)

Phoenix Biomedical Campus

Phoenix, Arizona, 85004, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31475194 BACKGROUND

• 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.

  PMID: 22927946 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 RESULT

• 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.

  PMID: 27161825 RESULT

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies

Study Officials

• Cindy C Ivy, OTD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy C Ivy, OTD

CONTACT

(602) 329-3878; Cynthia.Ivy@nau.edu

Linda Denney, PhD

CONTACT

6028272665; linda.denney@nau.edu

Study Design

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

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: November 23, 2021
• Study Start: December 12, 2020
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)