Laser Shoes for Freezing in People With Parkinson's Disease

November 22, 2021 updated by: Northern Arizona University

Assessing the Use of Lasers on Shoes for Freezing of Gait in People With Parkinson's Disease: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Phoenix Biomedical Campus
        • Contact:
        • Contact:
          • Linda Denney, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People with PD who exhibit freezing, on medications

Exclusion Criteria:

  • People who are non-ambulatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People with Parkinson's disease on medication who freeze
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
use of lasers on shoes to potentially minimize freezing of gait
Other Names:
  • A gait task and activity of daily living task without laser shoe attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freezing Severity
Time Frame: 4 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freezing of Gait Ratio
Time Frame: 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.
Freezing of gait (FoG) ratio is calculated from acceleration of the shins (measured via inertial sensors, Opals by APDM) in-place turning. First, power spectral density from antero-posterior acceleration signals are calculated. Then, a FoG ratio is calculated as the ratio of total power in the "freezing band" (3-8 Hz) and the "locomotion band" (0.5-3 Hz). Higher freezing ratios indicate higher severity of FoG. (Tang et al., 2019).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step length during gait
Time Frame: 4 hours
The step length during gait as quantified by gait map recording.
4 hours
Foot angle during gait
Time Frame: 4 hours
The foot angle during gait as quantified by gait map recording.
4 hours
Foot height during gait
Time Frame: 4 hours
The foot height during gait as quantified by gait map recording.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Arizona University

Collaborators

Arizona State University
FY2020 Research Bridge

Investigators

  • Principal Investigator: Cindy C Ivy, OTD, Northern Arizona University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2020

Primary Completion (Anticipated)

July 14, 2022

Study Completion (Anticipated)

July 14, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1550436-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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