Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05913219

Smart Wearable Device (gaitQ): Walk Better Project

Led by University of Exeter · Updated on 2025-12-15

150

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

University of Exeter

Lead Sponsor

G

GaitQ company

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Smart Wearable Device (gaitQ): Walk Better Project

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with long-term conditions affecting movement, such as Parkinson's disease (diagnosed by UK Brain Bank Criteria), stroke, multiple sclerosis, arthritis, or osteoporosis
  • Able to self-report daily gait freezing or festination for Parkinson's disease or gait affected by condition
  • Able to walk unsupported or with an aid for at least 3 minutes and pass the Canadian PARQ (if over 69 years)
  • Adults aged 18 years or older
  • Normal or corrected-to-normal vision (Snellen Visual Acuity > 12/18) or safe to move with support
  • Montreal Cognitive Assessment score above 21 or ability to follow two-stage commands
  • Healthy adults aged 18 years or older with no long-term conditions affecting movement
  • Healthy adults able to walk unsupported or with an aid for at least 3 minutes and pass the Canadian PARQ (if over 69 years)
  • Healthy adults with normal or corrected-to-normal vision or safe to move with support
  • Healthy adults with Montreal Cognitive Assessment score above 21 or ability to follow two-stage commands
Not Eligible

You will not qualify if you...

  • Any physical or mental condition that prevents safe participation or understanding of testing, including inability to safely follow commands or pass the PARQ
  • Cognitive impairment affecting safe participation and following instructions
  • Any injury or disorder affecting balance other than Parkinson's disease or the primary condition
  • Skin conditions or broken skin on the calf or behind the knee area
  • Presence of deep brain stimulation, pacemaker implants, or other implants that could interfere with the measurement system

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Exeter

Exeter, United Kingdom, EX1 2LU

Actively Recruiting

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Research Team

H

Helen Dawes, PhD

CONTACT

M

Mae Mansoubi, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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