The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease

NCT02356536 | Completed Phase 1

• 1 other identifier: 2013000952
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the resumption of normal walking. It is designed for use in PD patients with FOG, in their home environment where FOG is most severe. Kinematic data will be logged by a memory card in the belt worn device recording FOG, and falls. The device will be used on 3 different settings in a gait laboratory environment, and then for 2 weeks in the patient's own home using the same 3 settings. A battery of psychometric instruments will be administered before and after the trial

Conditions

Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• Total seconds of FOG

  duration of freezing with device on versus During the 2 week home trial, Kinematic data to capture FOG duration will be logged on the device during the same time period each day with the device on different settings. Fall data will collected from 6am to 10pm. FOG episodes on all 3 settings of the device will be recorded. The primary outcome measure will be the total seconds of FOG when the device is simply recording compared with the total FOG seconds when a FOG dependent ( or continuous FOG independent) cue is provided by the device. This will be recorded by means of a microSD card within the device. The data will be downloaded once the device is returned

  2 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Device: Agilitas

Interventions

Agilitas DEVICE

WCD trial

Experimental

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's Disease, clinically significant freezing of gait, no significant medical comorbidities

You may not qualify if:

• Non-english speaking, dementia, wheelchair or mobility aid dependent

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

University of Queensland

Brisbane, Queensland, 4000, Australia

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• rodney i marsh, MBBS

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 5, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

AU (1)