Parkinson's DiseaseNCT05019469
Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing
A study testing Rhythmic vibration cueing (lower leg) in people with Parkinson's Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rhythmic vibration cueing (lower leg)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2019to 22 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Bosworth Clinic
Cassington, Oxfordshire, OX29 4DS
About this study
Official title: Investigating Responsive Vibration Cueing Modalities From a Wearable Device to Overcome Gait Freezing in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Rhythmic vibration cueing (lower leg)
- Keywords
- Parkinson's Disease, Gait freezing, Cueing, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic vibration cueing (lower leg)Device
A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
| Study group | Role | What they receive |
|---|---|---|
| Single arm of study | Experimental | 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. Receives: Device: Rhythmic vibration cueing (lower leg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collected during 1 hour sessions up to study completion.
Secondary outcomes (1)
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.
Measured: Movement data collected during 1 hour sessions up to study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start13 Feb 2019
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Cantley, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019469
- Sponsor's protocol ID
- IRAS_216723
- Other IDs
- 18/SW/0235
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data points will be shown in the manuscript/publication reporting the study outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Responsive Vibration Cueing Modalities From a Wearable Device to Overcome Gait Freezing in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05019469
- Acronym / sponsor ID
- IRAS_216723
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Gait freezing, Cueing, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm of study | Experimental | Device: Rhythmic vibration cueing (lower leg)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic vibration cueing (lower leg)A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered. | Device | Single arm of study |
Primary outcome
Step frequency
Time frame: Data collected during 1 hour sessions up to study completion.
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.
1 secondary outcome
Automated gait freeze detection
Time frame: Movement data collected during 1 hour sessions up to study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Yes. Individual participant data points will be shown in the manuscript/publication reporting the study outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cantley, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic vibration cueing (lower leg) in people with Parkinson's Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step frequency (time frame: Data collected during 1 hour sessions up to study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.