Parkinson
Conditions
Keywords
gait, walking capacity, neuroplasticity, motor learning, quality of life
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.
Interventions
DEVICEHeel2Toe
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
OTHERNo-feedback control group
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.
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
An evaluator who does not know to which group the participant was assigned will conduct the evaluations. The outcomes are tests of performance.
Intervention model description
Standard two-group, sequential design, with 2:1 randomization (intervention:control) and only a within-group analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliable Change in Six-Minute Walk Test | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Performance-rated outcome |
| Change in Standardized Walking Obstacle Course (SWOC) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Quality (Data capture from Heel2Toe sensor) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)] | Technologically-reported outcome |
| Change in Lower Extremity Function (Neuroqol) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Patient-reported outcome on degree of difficulty with activities related lower extremity function |
| Change in Postural Instability and Gait Dysfunction (UPDRS) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Self-reported outcome of limitations |
| Safety (Falls) | Baseline to 3 months. | Self-reported number of falls during study period |
| Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Patient-reported outcome |
| Change in health states (Visual Analogue Health States) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Patient reported outcome of 8 health states measured on 0 to 10 scale |
| Cognitive performance (Symbol Digit Modality Test) | Baseline, 3 months, 6 months | Performance-rated outcome |
| Change in health-related quality of life (EQ-5D-3L) | Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months) | Patient-reported outcome (EQ-5D-3L) |
| Technology acceptability (System Usability Scale) | 3 months (1 time point) | Patient-reported outcome on satisfaction and intent-to-use |
Countries
Canada
Outcome results
None listed