Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03538756
Brief Summary:
The purpose of this study is to investigate the long-term effects of Walkasins® use on clinical and subject-reported outcomes of balance and gait function, quality of life, physical activity/participation, pain, and medication use in persons with peripheral neuropathy who experience balance problems.
Detailed Description:
The main objectives of this single-arm study are to show a long-term (10 weeks), sustained improvement in Functional Gait Assessment (FGA) score \>4 following Walkasins use as compared to participants' initial baseline assessments and to examine a potential relationship between initial baseline assessment data and long-term outcomes. The previous finding of a short-term FGA change \>4 during Walkasins use (NCT02115633) justifies a pre-post study design to investigate the long-term effects of Walkasins use. Although the primary timeframe for the primary endpoint is 10 weeks, participants will return for follow-up visits at 26 weeks and 52 weeks of Walkasins use.
The investigators also intend to extend their observations of the short-term effects of Walkasins by replicating the randomized cross-over design of a previous short-term study. (The randomized cross-over replication will occur only during the baseline visit. The long-term study consists of a single arm.) This study may help to further refine the prescription criteria for Walkasins and determine whether or not the presence of a short-term response is indicative of long-term improvements.
A subset of 10 participants at the Harvard Medical School site will be enrolled in a pilot study to investigate possible structural and functional changes in cortical areas of the brain related to somatosensory connectivity using magnetic resonance imaging (MRI). Structural as well as functional MRI scans will be acquired at baseline and after 26 weeks of daily Walkasins use. An exploratory analysis of MRI data will be performed and related to functional clinical outcomes associated with Walkasins use over the same time period.
Study:
NCT03538756
Study Brief:
Protocol Section:
NCT03538756