Clinical trial NCT04300348: Improving Walking With Heel-To-Toe Device
Official title: Real-time Auditory Feedback for Improving Gait and Walking in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson
Keywords: gait
walking capacity
neuroplasticity
motor learning
quality of life
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard two-group, sequential design, with 2:1 randomization (intervention:control) and only a within-group analysis.
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reliable Change in Six-Minute Walk Test
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Change in Standardized Walking Obstacle Course (SWOC)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
Secondary outcomes:
measure: Safety (Falls)
timeFrame: Baseline to 3 months.
measure: Technology acceptability (System Usability Scale)
timeFrame: 3 months (1 time point)
measure: Change in Gait Quality (Data capture from Heel2Toe sensor)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)]
measure: Change in Lower Extremity Function (Neuroqol)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Change in Postural Instability and Gait Dysfunction (UPDRS)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Change in health-related quality of life (EQ-5D-3L)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Change in health states (Visual Analogue Health States)
timeFrame: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
measure: Cognitive performance (Symbol Digit Modality Test)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Research Institute - MUHC
name: Nancy Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.