Recruiting

Laser Shoes

Sponsor:

Northern Arizona University

Code:

NCT05131906

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

gait task and activity of daily living task

Study Details

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

Study ID

NCT05131906

Start date

Dec 12, 2020

Status verified date

Nov, 2021

Completion date

Jul 14, 2022

Anticipated

Primary completion date

Jul 14, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • People with PD who exhibit freezing, on medications

Exclusion Criteria:

  • People who are non-ambulatory

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

gait task and activity of daily living task

use of lasers on shoes to potentially minimize freezing of gait

Primary outcome measure

  • Freezing Severity [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Locations

Phoenix Biomedical Campus

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

More Information

Sponsor

Northern Arizona University

Last update posted

Nov 23, 2021

Last verified

Nov, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northern Arizona University on 2021-11-23.