An interventional study of Rhythmic vibration cueing (lower leg) in Parkinson's Disease, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by University of Oxford · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 17 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
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.
Device: Rhythmic vibration cueing (lower leg)
A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
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.
Time frame: Data collected during 1 hour sessions up to study completion.
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.
Time frame: Movement data collected during 1 hour sessions up to study completion.
Plan to share: Yes — Individual participant data points will be shown in the manuscript/publication reporting the study outcomes.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of Oxford