Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Oxfordshire
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Cassington、Oxfordshire、英国、OX29 4DS
- The Bosworth Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Single arm of study
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.
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A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Step frequency
大体时间：Data collected during 1 hour sessions up to study completion.
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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.
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Data collected during 1 hour sessions up to study completion.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Automated gait freeze detection
大体时间：Movement data collected during 1 hour sessions up to study completion.
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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.
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Movement data collected during 1 hour sessions up to study completion.
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合作者和调查者
调查人员
- 首席研究员：James Cantley, PhD、University of Oxford
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- IRAS_216723
- 18/SW/0235 (其他标识符：NHS Health Research Authority REC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Rhythmic vibration cueing (lower leg)的临床试验
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Massachusetts Institute of TechnologyHanger Clinic: Prosthetics & Orthotics招聘中