CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 44 enrolled
Drug / intervention
Sensory Augmentation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03988400
NCT03988400Early Ph 1Completed

Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability

VA Office of Research and Development·interventional·Posted Jun 17, 2019·Updated Sep 19, 2024

In Brief

A Early Phase 1 clinical trial evaluating Sensory Augmentation and Random Vibration for Stroke. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedJun 17, 2019
Enrollment StartApr 4, 2022
Primary CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.0 years ago

Interventions

Sensory Augmentationbehavioral

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.

Random Vibrationbehavioral

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.