Clinical trial NCT04721860: Optimizing Training in Severe Post-Stroke Walking Impairment
Official title: Optimizing Training in Severe Post-Stroke Walking Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Chronic Stroke
Walking, Difficulty
Gait, Hemiplegic
Keywords: Gait
Balance
Non-body weight supported treadmill training
Backward locomotion treadmill training
Forward locomotion treadmill training
Walking Rehabilitation
Walking Recovery
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified Randomization
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Walking speed less than or equal to 0.4 meters/second
* Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill
* Able to walk independently (cane and hemi-walker acceptable)
* Ambulate \>10 meters over ground with the Free Step Harness System (as a safety precaution)
* Discharged from formal rehabilitation

Exclusion Criteria:

* Unstable cardiac status which would preclude participation in a moderate-intensity exercise program.
* Significant language barrier which might prevent the participant from following instructions during training and testing.
* Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect)
* Severe lower extremity spasticity (Ashworth \>2)
* Depression (\>10 on the Patient Health Questionnaire, if untreated).

Primary outcomes:
measure: Change in 10-Meter Walk (fast)
timeFrame: Pre-Baseline (Day of Randomization) to One Day Post-Training
Secondary outcomes:
measure: 10-Meter Walk Test (Fast- Retention)
timeFrame: One Day Post Training, One month Post Training, 3- Months Post Training
measure: 10-Meter Walk (Comfortable)
timeFrame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training
Other outcomes:
measure: Temporal Symmetry Index
timeFrame: Temporal Symmetry Index
measure: Static Balance: Sway Index (SI)
timeFrame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training
measure: Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 3 Meter
timeFrame: Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
measure: Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 7 Meter
timeFrame: Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
References: