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Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rhythmic vibration cueing (lower leg)
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's Disease, Gait freezing, Cueing, Gait

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Participant is fluent in English.
  • Participant is aged 18-90 years inclusive
  • Patients in whom the clinical diagnosis is stated as idiopathic Parkinson's disease or Parkinson's disease (PD).
  • Participant self-reports a history of daily gait freezing (several times a day), but should be able to stand and walk freely for short periods with minimal assistance.
  • Participant has no evidence for significant cognitive impairment.
  • In the investigator's opinion, is willing and able to comply with all trial requirements.

Exclusion Criteria:

  • Participant has a medical or psychiatric illness that would interfere with completing initial and follow up assessments.
  • Participant has severe mental impairment, dementia or psychosis determined either by a prior diagnosis by a medical professional with relevant expertise, or by subjective assessment by the research team during the pre-study questionnaire (e.g. an inability to comprehend questions).
  • Active participation in a clinical drug trial.
  • Female who is pregnant, lactating or planning pregnancy during the course of the investigation. This information will be provided to us by the patient during recruitment screening.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Patients with frequent (daily) falls at home or out of home, or who demonstrate a high fall risk during the study.
  • Patients with atypical parkinsonism (eg MSA, PSP, CBD).
  • Patients who have had Deep Brain Stimulation for their PD.

Sites / Locations

  • The Bosworth Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm of study

Arm Description

Single Arm. During each study session the participant undertakes 4 walking/activity circuits. During each circuit the participant receives either continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. The ordering of the interventions/circuits are systematically alternated for each participant.

Outcomes

Primary Outcome Measures

Step frequency
The primary objective is to test if gait-freeze initiated vibration cues, provided at the lower-leg, can improve gait/walking quality in PD patients. The primary outcome measure will be cadence (step frequency) with other gait measurements including frequency and duration of gait freeze events, continuous walking time, left/right rhythm and stride length. Measurements extracted from video data collected during 1 hour study sessions. Change in these measurements assessed between cued (intervention) and no-cue (no intervention) walking circuits for each participant.

Secondary Outcome Measures

Automated gait freeze detection
Generation of algorithms capable of recognising gait freeze events from device movement data with >80% accuracy. Algorithm development to identify changes in accelerometer (g) and gyroscope (rsp) data from leg-worn devices indicative of gait freeze events. Algorithm accuracy expressed as % sensitivity and % specificity for identifying gait freeze events from movement data relative to observer time stamps.

Full Information

First Posted
August 4, 2021
Last Updated
August 18, 2021
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05019469
Brief Title
Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing
Official Title
Investigating Responsive Vibration Cueing Modalities From a Wearable Device to Overcome Gait Freezing in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this pilot/feasibility study is to test if delivering rhythmic vibration cues to the lower legs, specifically in response to gait defects (rather than continuously), can improve walking quality and overcome gait freezing in Parkinson's disease. During the study, people with Parkinson's disease that suffer from regular (daily) gait freezing will undertake a series of walking/activity circuits, receiving continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. Vibration cueing is provided by a non-invasive wearable device prototyped at the University of Oxford, worn on the lower legs during 3 circuits. A series of walking metrics will be analysed.
Detailed Description
Parkinson's disease (PD) is a progressive, neurodegenerative disorder that impairs the ability to control movement. Gait freezing is an inability to walk spontaneously and continuously, and affects nearly half of PD patients, reducing quality of life and contributing to increased fall risk. Cueing (with visual, auditory or somatosensory stimuli) is an effective way to improve walking quality in people with PD. In this pilot study we aim to test if delivering rhythmic vibration cues acutely, specifically in response to gait defects, can improve walking quality and overcome gait freezing in PD. During the study, people with PD that suffer from regular (daily) gait freezing, but who are able to stand and walk with minimal assistance, undertake 4 walking/activity circuits. During each of the circuits participants receive either continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. Cueing is provided by a non-invasive wearable movement-tracking cueing device prototyped at the University of Oxford (approximately the size of a smart phone), worn on the lower legs during 3 circuits. The ordering of the interventions/circuits are systematically alternated for each participant. The impact of responsive cueing on walking ability can be determined by analysis of walking metrics across the circuits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Gait freezing, Cueing, Gait

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm of study
Arm Type
Experimental
Arm Description
Single Arm. During each study session the participant undertakes 4 walking/activity circuits. During each circuit the participant receives either continuous cueing, responsive cueing (delivered in response to gait freezing), no cueing and no device. The ordering of the interventions/circuits are systematically alternated for each participant.
Intervention Type
Device
Intervention Name(s)
Rhythmic vibration cueing (lower leg)
Intervention Description
A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
Primary Outcome Measure Information:
Title
Step frequency
Description
The primary objective is to test if gait-freeze initiated vibration cues, provided at the lower-leg, can improve gait/walking quality in PD patients. The primary outcome measure will be cadence (step frequency) with other gait measurements including frequency and duration of gait freeze events, continuous walking time, left/right rhythm and stride length. Measurements extracted from video data collected during 1 hour study sessions. Change in these measurements assessed between cued (intervention) and no-cue (no intervention) walking circuits for each participant.
Time Frame
Data collected during 1 hour sessions up to study completion.
Secondary Outcome Measure Information:
Title
Automated gait freeze detection
Description
Generation of algorithms capable of recognising gait freeze events from device movement data with >80% accuracy. Algorithm development to identify changes in accelerometer (g) and gyroscope (rsp) data from leg-worn devices indicative of gait freeze events. Algorithm accuracy expressed as % sensitivity and % specificity for identifying gait freeze events from movement data relative to observer time stamps.
Time Frame
Movement data collected during 1 hour sessions up to study completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Participant is fluent in English. Participant is aged 18-90 years inclusive Patients in whom the clinical diagnosis is stated as idiopathic Parkinson's disease or Parkinson's disease (PD). Participant self-reports a history of daily gait freezing (several times a day), but should be able to stand and walk freely for short periods with minimal assistance. Participant has no evidence for significant cognitive impairment. In the investigator's opinion, is willing and able to comply with all trial requirements. Exclusion Criteria: Participant has a medical or psychiatric illness that would interfere with completing initial and follow up assessments. Participant has severe mental impairment, dementia or psychosis determined either by a prior diagnosis by a medical professional with relevant expertise, or by subjective assessment by the research team during the pre-study questionnaire (e.g. an inability to comprehend questions). Active participation in a clinical drug trial. Female who is pregnant, lactating or planning pregnancy during the course of the investigation. This information will be provided to us by the patient during recruitment screening. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Patients with frequent (daily) falls at home or out of home, or who demonstrate a high fall risk during the study. Patients with atypical parkinsonism (eg MSA, PSP, CBD). Patients who have had Deep Brain Stimulation for their PD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Cantley, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Bosworth Clinic
City
Cassington
State/Province
Oxfordshire
ZIP/Postal Code
OX29 4DS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data points will be shown in the manuscript/publication reporting the study outcomes.

Learn more about this trial

Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing

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