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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04721860
Brief Summary:
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
Detailed Description:
Severe walking impairment after stroke is defined as the inability to walk faster than 0.4 meters per second and impacts nearly twenty-five percent of chronic stroke survivors. Walking speed is a key determiner of community independence, and stroke survivors classified as "severe" are more often symptomatically home-bound with limited mobility and are at higher risk of falls, fractures, and rehospitalizations. A recent study by the investigators suggests that backward locomotion treadmill training (BLTT) may be a promising rehabilitative approach in stroke survivors with severe walking impairment; however, the effect of training duration on behavioral outcomes is unknown.
The objective of this study is to obtain critical pilot data on the effects of extended BLTT on walking speed, symmetry, and balance (static and dynamic), in chronic stroke survivors with baseline severe walking impairment, relative to forward treadmill training controls (FLTT).
Aim 1. Determine the training-related effects of extended BLTT on overground walking speed (primary outcome) in survivors with severe walking impairment. To achieve this aim, we will compare the Pre-Post change in walking speed \[10- meter walk test (10MWT)\] between groups. The working hypothesis is that extended BLTT will increase walking speed to a clinically meaningful level (≥0.16m/s), compared to the control group (FLTT).
Aim 2. Determine the effects of extended BLTT on walking symmetry and balance. The Zeno Walkway Gait Analysis software will capture Pre-Post changes in temporal gait symmetry index during the 10-MWT. Working hypothesis 2a: BLTT will be associated with a favorable improvement in the temporal symmetry index score. Proprioception and spinovestibular function will be measured with the modified Sensorineural Integration Test (mSIT), and dynamic balance will be assessed with the completion time on the instrumented Timed Up \& Go (i- TUG). Working hypothesis 2b and c: BLTT will be associated with a favorable improvement Pre-Post mSIT(a) and completion time on the i-TUG (b).
Study:
NCT04721860
Study Brief:
Protocol Section:
NCT04721860