Improving Walking With Heel-To-Toe Device
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Standard two-group, parallel design, with intention-to-treat and per-protocol analysesMasking: 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.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 variabi...
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 per group with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.
Tracking Information
- NCT #
- NCT04300348
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nancy Mayo, PhD Research Institute - MUHC
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