Smart Wearable Device (gaitQ): Walk Better Project
Smart Wearable Device (gaitQ) That Helps People With Long-term Conditions Affecting Movement: Walk Better
University of Exeter
150 participants
Sep 15, 2023
OBSERVATIONAL
Conditions
Summary
This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models alongside COSMIN methodology for validating a measure. Research question: To what extent does gaitQ's smart cueing system improve people with long-term conditions including people with Parkinson's (PwP's) gait? Is it effective in the everyday environment? What factors are associated with good mobility? What is the impact of cueing on healthy people? Aims and objectives: To finalise the product development and evaluation comprising (1) algorithm refinement and (2) monitoring system development. To evaluate the reliability, concurrent validity, and potential for efficacy, as determined by responsiveness in response to the gaitQ product using gait data collected in laboratory environments. To prepare for market entry and NHS adoption: early economic modelling, pricing, marketing strategies, and early adopter partnerships. Design: Participatory design with testing for validity, reliability and responsiveness Participants: This will involve healthy people and people with long-term conditions affecting their movement, including people with Parkinson's \[PwP\]. Additional patient groups will be investigated, including stroke, and people with hip/knee injuries. Methods The Researchers will collect movement data using the gaitQ system, which monitors and cues, to both collect data and cue in the lab environment and investigate the reliability of the measure, concurrent validity of the metric to gold standard gait capture, the responsiveness of measures to the cueing system and usability for participants and clinical teams. To determine reliability, 60 participants will be invited to repeat testing on a second visit. Researchers will describe participants' conditions using standard questionnaires and their mobility and functioning. This study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models to identify intrinsic and extrinsic factors that contribute to a given outcome in a specific population.
Eligibility
Inclusion Criteria13
- Eligibility Criteria This research will investigate the impact of the gaitQ product on a sufficiently large cohort of PwP, healthy controls and other potential conditions such as stroke and hip and knee replacements.
- Participants with long-term conditions affecting movement
- Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition-specific scales \[stroke, multiple sclerosis, arthritis or osteoporosis\]
- Able to self-report history of daily gait freezing and/or festination for people with PD or gait affected by condition
- Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carry out this level of exercise
- Adult (+18 years old)
- Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support
- Montreal Cognitive assessment score \>21 or ability to follow 2-stage commands
- Healthy participants
- With no long-term conditions affecting movement
- Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise
- Adult (+18 years old)
- Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support
Exclusion Criteria12
- Participants with long-term conditions affecting movement
- Any physical or mental condition affecting the ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.
- Cognitive impairment affecting the ability to safely participate and follow instructions
- Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
- Any skin conditions or broken skin in the calf and behind the knee area
- Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system
- Healthy participants
- Any physical or mental condition affecting the ability to safely participate in this level of activity and capacity to understand testing as demonstrated by the ability to safely follow commands and pass the PARQ by the research team.
- Cognitive impairment affecting the ability to safely participate and follow instructions
- Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
- Any skin conditions or broken skin in the calf and behind the knee area
- Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05913219