Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
Condition: Stroke; Chronic Stroke; Walking, Difficulty; Gait, Hemiplegic
MeSH terms: Stroke; Gait Disorders, Neurologic; Mobility Limitation
Study type: Interventional

Summary: 
      Despite current walking rehabilitation strategies, the majority of stroke survivors are
      unable to walking independently in the community and remain at increased risk of falls.
      Backward treadmill training is a novel training approach used by elite athletes to enhance
      speed, agility, and balance; however, it is currently unknown how this exercise interacts
      with the central nervous system or if it could benefit stroke survivors with residual walking
      impairment. Knowledge gained from this study will likely lead to more effective walking
      rehabilitation strategies in stroke and related disorders.
    

Detailed description: 
      Walking impairment after a stroke impacts nearly 66% of stroke survivors and is a rising
      cause of morbidity worldwide. Despite ongoing efforts to increase the quality and delivery of
      rehabilitative care, less than ten percent of stroke survivors ever achieve walking
      independence within the community and are at higher risk of falls, fractures,
      rehospitalization. Several factors may lead to walking impairment, but the two most prevalent
      causes are lower extremity asymmetry and imbalance. Herein, the investigators propose
      backward locomotion treadmill training (BLTT), as a promising approach for walking
      rehabilitation in stroke survivors.

      Hence, our central hypothesis is that BLTT facilitates sensory signaling, leading to an
      improvement in walking speed. The investigators have preliminary proof of technique and
      feasibility data suggesting that BLTT is safe and feasible for stroke patients, with our
      results showing clinically meaningful improvement in overground walking speed after just six
      training sessions, with retention at the two-week follow-up. The next logical step in
      planning toward a future definitive clinical trial is to determine its preliminary efficacy
      compared with conventional forward walking treadmill training (FLTT) as control.

      The investigators plan to test the preliminary efficacy of BLTT by conducting a prospective,
      randomized, blinded-endpoint, pilot study of 40 individuals with residual mild-moderate gait
      impairment, >6 months post-stroke, to BLTT (n=20) versus FLTT (n=20), for nine 30-minute
      training session (3 sessions/week). The investigators will utilize well-validated behavioral
      measures in stroke recovery and rehabilitation to test the following Aims:

      Aim 1. Determine the training-related effects of BLTT on overground walking speed (primary
      outcome) To achieve this aim, the investigators will compare the Pre-Post change in walking
      speed [10- meter walk test (10MWT)] between groups. Our working hypothesis 1 is that BLTT
      will increase walking speed (>0.13m/s), compared to the control group (FLTT).

      Aim 2. Determine the effects of training on walking symmetry, proprioceptive signaling, and
      dynamic 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(b) and completion time on the i-TUG (c).
    

Intervention name(s): Backward Locomotion Treadmill Training (BLTT)
Intervention type(s): Behavioral
Intervention description(s): 9-training sessions of reverse treadmill training (no bodyweight support)over three weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: stratified randomization
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gait; Balance; Non-body weight supported treadmill training; Backward locomotion treadmill training; Forward locomotion treadmill training; Walking Rehabilitation; Walking Recovery