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ParkinsonNCT04300348

Improving Walking With Heel-To-Toe Device

A study testing Heel2Toe in people with Parkinson, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: The purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with Parkinson's Disease (PD). The components of walking are commonly affected in patients with PD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson
What is being tested?
Heel2Toe
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteCanada
Study dates
15 Apr 2021to 30 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Parkinson Disease and be independent in ambulation without use of walking aid

Who cannot join

  • exercising three or more time per week;
  • Had any additional illness that restricted their function
  • Showing difficulty reading, understanding or speaking either French or English

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Center

    Montreal, Quebec, H4A 3S5

Other trials in Canada

About this study

Official title: Real-time Auditory Feedback for Improving Gait and Walking in People With Parkinson's Disease

Introduction: The purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with Parkinson's Disease (PD). The components of walking are commonly affected in patients with PD. Gait training for PD is usually based on verbal cues from the therapist that are only moderately effective. Based on good principals of gait and neuroplasticity, the Heel-To-Toe (Heel2Toe) sensor was developed to provide real-time auditory feedback during walking training. Methods: A two-group, randomized feasibility trial is planned with repeated measures of gait parameters and walking outcomes. Participants will be assessed at baseline, 3 and 6 months. Outcomes after the 5 training days will be obtained directly from the Hee2Toe device for both groups (with and without auditory feedback). The primary outcome is walking capacity measured by the Six-Minute Walk Test and the Standardized Walking Obstacle Course. Gait parameters will be captured by the Heel2Toe device Expected Contributions: Gait training using the Heel2Toe sensor will be potentially effective for improving walking pattern in people with PD.

Read the detailed description

As this is a feasibility study, the main analysis will focus on within-group change over the intervention period of 3 months using indices of reliable change(36). This method assesses the number of people who changed in each of the groups based on the magnitude of change relative to pre-post variability and correlation. We will estimate the proportion of people with reliable change. Estimates from the pilot study will be used to plan the main trial if the pilot demonstrates feasibility. For the maintenance period, reliable change from baseline will also be estimated and used to identify the proportion of people who maintained reliable change or who gained/lost this status.

The study is designed to detect a minimal important within-group change of moderate magnitude or greater (effect size ½ standard deviation) with adequate precision. A sample size of 20 in the intervention with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.

Conditions
Parkinson
Being tested
Heel2Toe, No-feedback control group
Keywords
gait, walking capacity, neuroplasticity, motor learning, quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heel2ToeDevice

    Heel to Toe (Heel2Toe) is a device that clips on the shoe and provides an instant auditory feedback (a beep) for each correct step characterized by putting the heel first and it provides data on gait parameters

  • No-feedback control groupOther

    The control group will follow the same protocol as the Heel2Toe group but the device will not be in feedback mode just in data acquisition mode.

Study groups in NCT04300348
Study groupRoleWhat they receive
Heel2Toe GroupActive comparatorThe Heel2Toe group will have 5 therapy sessions to learn to trigger the sensor with a strong heel strike and how to use device for home practice for 3 months. During the home practice, participants will be instructed to walk with the device for a minimum of 10 minutes per day in feedback mode. They will be provided with a workbook outlining simple exercises targeting functions needed to walk well (Walk-BEST Workbook) in paper and as a mobile app.
Receives: Device: Heel2Toe
No-feedback Control Group (Control group)OtherThe Control group will do the same 5 sessions of training and 3 months of practice but without the Heel2Toe device in feedback mode, just in data acquisition mode. They will be provided with a workbook outlining simple exercises targeting functions needed to walk well (Walk-BEST Workbook) in paper and as a mobile app.
Receives: Other: No-feedback control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reliable Change in Six-Minute Walk Test

    Performance-rated outcome

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  2. Change in Standardized Walking Obstacle Course (SWOC)

    Performance-rated outcome of challenges experienced with starting, stopping, turning, making motor decisions. The metric is the time to complete a 12.2-m long, 0.92-m wide curved pathway, with obstacles commonly encountered in daily life.

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

Secondary outcomes (9)

  1. Safety (Falls)

    Self-reported number of falls during study period

    Measured: Baseline to 3 months.

  2. Technology acceptability (System Usability Scale)

    Patient-reported outcome on satisfaction and intent-to-use

    Measured: 3 months (1 time point)

  3. Change in Gait Quality (Data capture from Heel2Toe sensor)

    Technologically-reported outcome

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)]

  4. Change in Lower Extremity Function (Neuroqol)

    Patient-reported outcome on degree of difficulty with activities related lower extremity function

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  5. Change in Postural Instability and Gait Dysfunction (UPDRS)

    Self-reported outcome of limitations

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  6. Change in health-related quality of life (EQ-5D-3L)

    Patient-reported outcome (EQ-5D-3L)

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  7. Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory)

    Patient-reported outcome

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  8. Change in health states (Visual Analogue Health States)

    Patient reported outcome of 8 health states measured on 0 to 10 scale

    Measured: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)

  9. Cognitive performance (Symbol Digit Modality Test)

    Performance-rated outcome

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start15 Apr 2021
  3. Primary completion30 Oct 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Standard two-group, sequential design, with 2:1 randomization (intervention:control) and only a within-group analysis.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300348
Sponsor's protocol ID
2020-5842
Status last verified
Mar 2023
First submitted
4 Mar 2020
Last updated
15 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mate KKV, Abou-Sharkh A, Morais JA, Mayo NE. Putting the best foot forward: Relationships between indicators of step quality and cadence in three gait vulnerable populations. NeuroRehabilitation. 2019;44(2):295-301. doi: 10.3233/NRE-182595.

    PubMed 30856128

  • Mate KK, Abou-Sharkh A, Morais JA, Mayo NE. Real-Time Auditory Feedback-Induced Adaptation to Walking Among Seniors Using the Heel2Toe Sensor: Proof-of-Concept Study. JMIR Rehabil Assist Technol. 2019 Dec 11;6(2):e13889. doi: 10.2196/13889.

    PubMed 31825320

  • Carvalho LP, Mate KKV, Cinar E, Abou-Sharkh A, Lafontaine AL, Mayo NE. A new approach toward gait training in patients with Parkinson's Disease. Gait Posture. 2020 Sep;81:14-20. doi: 10.1016/j.gaitpost.2020.06.031. Epub 2020 Jun 29.

    PubMed 32650238

Questions about this trial

What is this clinical trial studying?

A study testing Heel2Toe in people with Parkinson, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reliable Change in Six-Minute Walk Test (time frame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300348, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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