Smart Wearable Device (gaitQ): Walk Better Project

NCT05913219 | Recruiting

• 1 other identifier: 2022-23-24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis; Parkinson Disease; Stroke; Multiple Sclerosis; Osteoporosis

Keywords

Parkinson, MS, osteoporosis, arthritis, Stroke

Outcome Measures

Primary Outcomes (9)

• Freezing and festinating events

  The number of freezing and festinating events during the following tasks performed with and without the gaitQ device (condition order will be randomised) will be recorded: 1. 10-meter walk 2. Timed Up and Go 3. 1-minute walk 4. Walking with increasing physical and cognitive distractions.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Step length

  Step length (meters) will be measured during gait tasks performed with and without the gaitQ device.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Step rate

  Step rate (steps per minute) will be measured during gait tasks performed with and without the gaitQ device.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Step length symmetry index

  Step length symmetry index will be calculated using the following equation: \[((R - L)/0.5 × (R + L)) × 100\], where R: right leg, L: left leg

  Day 1 (& Day 2 for the reliability arm n= 60)

• Walking speed

  Walking speed (meters per second) will be measured during the gait activities with and without the gaitQ device.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Acceptability of the gaitQ device

  Acceptability of the gaitQ device will be assessed with questionnaires and completion \>70% of the planned sessions.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Safety of the gaitQ device

  Safety of the gaitQ device will be assessed by recording the adverse events (expected and unexpected).

  Day 1 (& Day 2 for the reliability arm n= 60)

• Usability of the gaitQ device

  Usability of the gaitQ device will be assessed through successful establishment of a system usability scale target \>68 and through the number of therapy support sessions required.

  Day 1 (& Day 2 for the reliability arm n= 60)

• Timed Up and Go

  The time (seconds) to complete the Timed Up and Go task will be recorded.

  Day 1 (& Day 2 for the reliability arm n= 60)

Study Arms (2)

Participants with long-term conditions affecting movement

A total number of 120 people with long-term conditions affecting their movement include people with Parkinson's (N=60), stroke (N=30), those living with arthritis (N=30).

Healthy control

A total number of 30 healthy people with no condition impacting their movement and walking ability.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for the research will include individuals with long-term conditions affecting movement (such as Parkinson's disease, stroke, multiple sclerosis, arthritis, or osteoporosis), healthy controls, and individuals with hip and knee replacements. The inclusion criteria for people with long-term conditions require participants to have a diagnosis of the specified conditions, self-report gait issues, be able to walk unsupported or with aid for at least 3 minutes, and meet certain vision and cognitive assessment criteria. The age requirement is 18 years or older. Participants should not have any physical or mental conditions affecting their ability to safely participate or understand the study, including cognitive impairment or balance-affecting disorders.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• GaitQ company: collaborator

Study Sites (1)

University of Exeter

Exeter, EX1 2LU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Stroke; Multiple Sclerosis; Osteoporosis; Arthritis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Joint Diseases

Study Officials

• Helen Dawes

  Professor of Clinical Rehabilitations

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Dawes, PhD

CONTACT

01392; h.dawes@exeter.ac.uk

Mae Mansoubi, PhD

CONTACT

0786613722; m.mansoubi@exeter.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: September 15, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)