Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001302549p
Ethics application status
Submitted, not yet approved
Date submitted
26/09/2024
Date registered
28/10/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
RhythmiGait: Auditory feedback to Support Gait Rehabilitation
Scientific title
Wearable Auditory Feedback System for Gait Rehabilitation in Adults with Neurological Conditions: A Study Assessing the Impact of Rhythmic Auditory Stimulation on Gait Parameters
Secondary ID [1] 313055 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gait impairment 335282 0
Stroke Rehabilitation 335283 0
Parkinson's Disease 335284 0
Balance Disorders 335285 0
Mobility Impairment 335286 0
Neurological Conditions 335287 0
Condition category
Condition code
Neurological 331857 331857 0 0
Parkinson's disease
Neurological 331858 331858 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 331859 331859 0 0
Other physical medicine / rehabilitation
Stroke 331860 331860 0 0
Haemorrhagic
Stroke 331861 331861 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims to evaluate whether Rhythmic Auditory Stimulation (RAS) delivered through a wearable auditory feedback device can improve gait parameters in individuals with neurological-related mobility impairments. The essential elements of the intervention are grounded in the theory that auditory cues can stimulate rhythmic motor activity, potentially improving stride length, cadence, and walking stability.

Intervention Arm (Wearable Auditory Feedback System)
Wearable Auditory Feedback System (Intervention Condition)
The intervention uses Rhythmic Auditory Stimulation (RAS), delivered through a wearable auditory feedback device, to guide participants’ walking patterns and improve gait. The goal is to assess whether real-time auditory cues can help participants regulate stride length, cadence, and overall gait stability during treadmill walking.

WHAT
Materials:
Wearable Auditory Feedback System: A mobile phone with an integrated gyroscope that collects real-time motion data from participants’ movements. The system is worn on the lower back (L4 region) using an adjustable belt. The device uses Bluetooth to provide auditory feedback through headphones or speakers. The feedback is based on participants' gait patterns and provides rhythmic cues to help them adjust their steps.

Procedures:
Participants will walk on the treadmill while wearing the auditory feedback device.
The wearable device will provide RAS, designed to help participants regulate their gait in real time. The auditory cues will guide participants’ stride length and cadence.
The treadmill speed will remain constant throughout the intervention, matching the speed used in the baseline condition.

WHO PROVIDED
The RMIT research team will oversee the intervention. All research staff will have appropriate training in operating the wearable device, monitoring participants, and ensuring safety during treadmill walking.
The research team will also provide instructions to participants on the use of the wearable device and monitor their progress during the intervention.

HOW
The intervention will be delivered individually to each participant in an in-person session. Auditory feedback will be administered in real time through the wearable system, with ongoing monitoring by the research staff.

WHERE
The intervention will take place at Klint Clinic in a controlled, supervised environment. The necessary infrastructure, including the treadmill, wearable device, and safety harness, will be available at the clinic.

WHEN and HOW MUCH
The intervention will be delivered once per participant during the treadmill walking task. The duration of the intervention will be consistent with the baseline and post-intervention phases, with rest breaks provided as needed.

TAILORING
The treadmill speed will be personalized to each participant’s comfort level at the beginning of the session. The auditory feedback will be tailored to each participant’s walking pattern, with rhythmic cues designed to match their step cadence.

MODIFICATIONS
No significant modifications to the intervention are planned. However, adjustments to treadmill speed or rest periods may be made based on participant fatigue or discomfort.

HOW WELL
Planned: The research team will ensure adherence to the intervention protocol by monitoring participants throughout the task. Any deviations from the planned intervention (e.g., changes to treadmill speed) will be documented.
Actual: Intervention fidelity will be assessed by reviewing the consistency of auditory feedback delivery and ensuring that all participants complete the walking task with the wearable system as planned.
Intervention code [1] 329610 0
Treatment: Devices
Intervention code [2] 329611 0
Rehabilitation
Intervention code [3] 329612 0
Behaviour
Comparator / control treatment
Control Arm (No Auditory Feedback)
No auditory feedback provided (Baseline and Post-Intervention Conditions)
The baseline and post-intervention conditions provide a comparison for gait performance without the influence of auditory feedback. This allows for the assessment of baseline gait parameters and short-term retention of any improvements after the intervention phase.

Baseline Condition (for the control):
Participants will walk on the treadmill without the auditory feedback system for a duration of 2 minutes. This will provide baseline data on their gait without any external guidance.
Control group
Active

Outcomes
Primary outcome [1] 339474 0
Change in Gait parameters such as Stride Length, Cadence (steps per minute) and Walking Speed will be assessed together as a composite primary outcome.

By using a composite outcome, we aim to capture the overall effect of the intervention on gait function, integrating these three key parameters to reflect the combined impact on walking performance. This approach allows for a comprehensive assessment of the wearable auditory feedback system's influence on participants' gait by examining changes across these interrelated aspects of movement.
Timepoint [1] 339474 0
The composite outcome of gait parameters—Stride Length, Cadence (steps per minute), and Walking Speed—will be assessed at the following timepoints:

1. Baseline (before the intervention).
2. Intervention
3. Immediately post-intervention (primary timepoint).
4. Five minutes after the intervention to assess retention.
Primary outcome [2] 339475 0
Change in Balance and stability

Change in Balance and Change in Stability will be assessed together as a composite primary outcome. Both measures will be combined to provide a comprehensive understanding of how the wearable auditory feedback system affects overall postural control and gait stability in participants.
Timepoint [2] 339475 0
The composite primary outcome of Change in Balance and Change in Stability will be assessed at the following timepoints:

1. Baseline (before the intervention).
2. Intervention
3. Immediately post-intervention (primary timepoint).
4. Five minutes after the intervention to assess retention of improvements
Primary outcome [3] 339476 0
Change in Range of Motion (Lower Limbs)
Timepoint [3] 339476 0
Range of Motion will be assessed at the following timepoints:


1. Baseline (before the intervention).
2. Intervention
3. Immediately post-intervention (primary timepoint).
4. Five minutes after the intervention to assess retention of improvements
Secondary outcome [1] 440147 0
Perceived Effort During Walking
Timepoint [1] 440147 0
Immediately after each walking condition (Baseline, Intervention, Post-Intervention).
Secondary outcome [2] 440148 0
Participant's Perception of the Auditory Feedback System
Timepoint [2] 440148 0
Immediately post-intervention and 5 minutes after the intervention.

Eligibility
Key inclusion criteria
Neurological Condition Impacting Gait:
Participants must have a documented neurological condition that impacts their gait, such as stroke, Parkinson's Disease, or other neurological disorders that impair motor control and balance.

Recovery Phase:
Participants should be in the recovery phase of their condition, actively undergoing or having completed rehabilitation aimed at improving gait and mobility.

Ability to Walk Independently:
Participants must be able to walk independently for short distances, either unassisted or with minimal assistance, and must be physically capable of walking on a treadmill for the duration of the study.

Age Range:
Participants should be adults aged 18 years and older. There is no upper age limit, provided the participant meets other eligibility criteria.

Ability to Consent:
Participants must have sufficient cognitive ability to understand the study and provide informed consent, either independently or with the assistance of a caregiver or family member.

Stable Medical Condition:
Participants must have a medically stable condition, with no major recent hospitalisations or interventions (e.g., surgery or hospitalisation within the last 3 months) that would preclude participation in physical rehabilitation activities.

Willingness to Participate:
Participants must be willing to participate in all study sessions, including wearing the auditory feedback device, walking on the treadmill, and completing all assessments and surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe Neurological or Musculoskeletal Impairments:
Individuals with severe neurological impairments that prevent independent walking, such as advanced-stage Parkinson’s Disease or severe post-stroke impairments, will be excluded. This includes participants who rely on full assistance for walking or have significant mobility limitations that cannot be addressed with treadmill walking.

Recent Surgery or Lower Limb Injuries:
Participants who have undergone major lower limb surgery or experienced a significant lower limb injury (e.g., fractures, ligament tears) in the past three months will be excluded due to the risk of exacerbating their condition during treadmill walking.

Cognitive Impairment Affecting Compliance:
Individuals with severe cognitive impairments (e.g., advanced dementia or significant memory disorders) that affect their ability to understand instructions, comply with the study protocol, or provide informed consent will not be eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the specific nature of the study and the target population (stroke survivors with specific mobility challenges), recruitment should be manageable within the context of a rehabilitation facility. A sample size of 40 participants is appropriate, which balances the need to gather sufficient data to evaluate the effect of the wearable auditory feedback system on gait. It helps to understand the preliminary efficacy while considering the logistic of recruitment and study management within the local context. The findings from this study will provide a foundation for larger, more definitive trials in the future.


Statistical Methods and Analysis Plan

Primary Outcome Analysis:
The primary outcomes (e.g., stride length, cadence, balance) will be evaluated using repeated measures ANOVA, depending on data distribution, to assess changes across the baseline, intervention, and post-intervention phases.

Post-hoc tests will be applied to examine specific pairwise comparisons (e.g., baseline vs. intervention, intervention vs. post-intervention) where significant differences are found.

Secondary Outcome Analysis:
Secondary outcomes such as perceived exertion (using the Borg Rating of Perceived Exertion Scale) and participant satisfaction will be analyzed using descriptive statistics and paired t-tests or Wilcoxon signed-rank tests if data is non-normally distributed.

Effect Size Calculation:
Effect sizes will be calculated using Cohen’s d for paired comparisons to estimate the magnitude of the intervention’s effect on gait parameters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43228 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 317497 0
University
Name [1] 317497 0
RMIT University
Country [1] 317497 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 319793 0
None
Name [1] 319793 0
Address [1] 319793 0
Country [1] 319793 0
Other collaborator category [1] 283240 0
Commercial sector/Industry
Name [1] 283240 0
Keegan Bow
Address [1] 283240 0
Country [1] 283240 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316208 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 316208 0
Ethics committee country [1] 316208 0
Australia
Date submitted for ethics approval [1] 316208 0
30/09/2024
Approval date [1] 316208 0
Ethics approval number [1] 316208 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137150 0
A/Prof Toh Yen Pang
Address 137150 0
A/Prof Toh Yen Pang, RMIT University, 124 La Trobe Street, Melbourne VIC 3000
Country 137150 0
Australia
Phone 137150 0
+61 3 9925 6128
Fax 137150 0
Email 137150 0
[email protected]
Contact person for public queries
Name 137151 0
Toh Yen Pang
Address 137151 0
A/Prof Toh Yen Pang, RMIT University, 124 La Trobe Street, Melbourne VIC 3000
Country 137151 0
Australia
Phone 137151 0
+61 3 9925 6128
Fax 137151 0
Email 137151 0
[email protected]
Contact person for scientific queries
Name 137152 0
Toh Yen Pang
Address 137152 0
A/Prof Toh Yen Pang, RMIT University, 124 La Trobe Street, Melbourne VIC 3000
Country 137152 0
Australia
Phone 137152 0
+61 3 9925 6128
Fax 137152 0
Email 137152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The individual participant data (IPD) for this trial will not be made publicly available. This decision is to ensure the protection of participant privacy and confidentiality, in line with ethical guidelines of RMIT University.

Aggregated and anonymized results of the study will be published, but no raw line-by-line participant data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.