Locomotor Recovery Following Traumatic Brain Injury
Condition: Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of two different walking
      training interventions on the recovery of strength, mobility, walking and other measures of
      health in individuals following traumatic brain injury. During this study, participants will
      aim to complete up to 15 training sessions over 4-5 weeks of each intervention with at least
      a 4 week break between interventions. Each training session will last approximately 1 hour,
      while testing sessions performed at the beginning and end of each intervention will last
      approximately 3-4 hours. Participation in this research study may last up to 6 months
      including screening and baseline testing. The possible benefits to participant from
      participation in this study include increased strength of the participants leg muscles and
      improved walking ability
    

Detailed description: 
      The primary goal of the proposed study is to identify the contributions of the amount of
      task-specific practice on locomotor (i.e., walking) recovery in patients with (> 6 Months)
      traumatic brain injury (TBI). The investigator will do this by building on our previous work
      directed towards identifying the essential exercise training parameters that maximize
      locomotor recovery. Consistent with principles of motor learning and exercise physiology, the
      investigator contend that certain training (i.e., dosage) parameters of physical
      rehabilitation, including the type (specificity) and amount of task practice, are critical to
      mobility outcomes following neurological injury. Previous work suggests these training
      parameters may influence locomotor recovery in patients with other neurological disorders
      (i.e., stroke), although few studies have attempted to delineate similar contributions of
      amount of task-specific practice in neurologic injury. Indeed, no studies have carefully
      controlled these training parameters during physical rehabilitation of patients with
      neurologic injury, and such interventions are rarely utilized in the clinical setting.
      Reasons for these knowledge gaps from other rehabilitation studies to patients with
      neurologic injury or lack of clinical implementation are unclear, but may be due to adherence
      to traditional rehabilitation theories. One concern is that practicing only stepping tasks
      reduces attention towards hallmark physical impairments following neurologic injury, such as
      loss of strength or postural stability, which are considered primary determinants of
      decreased mobility. Only a few studies have addressed whether providing only structured
      stepping training can mitigate these impairments without their explicit practice, but not in
      the neurologic injury population. A related concern is that focused stepping training without
      significant attention towards impairments or gait quality may exaggerate altered movement
      strategies, which could be reinforced with repeated practice. However, there is little data
      to suggest "worsening" of abnormal gait patterns following high intensity training. Rather,
      recent findings suggest patients demonstrate more normal kinematics. If focused task specific
      (i.e., stepping) training is to be applied clinically, participant must delineate its
      contributions towards improving locomotor function, and their effects on underlying
      impairments and gait kinematics.

      Central hypotheses are that stepping training in TBI results in:1) greater locomotor gains as
      compared to non-specific interventions; 2) gains in selected impairments underlying gait
      dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in
      gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized
      clinical trial (RCT) is designed to test the effects of specificity of rehabilitation
      training applied early-post-stroke. In this RCT, patients > 6 post-TBI will be allocated ≤ 15
      sessions over approximately 4-5 weeks of high-intensity stepping training or conventional
      therapy. Importantly, training intensity will be held constant to account for this potential
      confounding factor. Blinded assessments will be performed prior to and following each
      training paradigm.
    

Intervention name(s): High Intensity Stepping Training; Conventional Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The goals will be to maximize stepping activity at high intensities for 40 minutes per 1 hour session, with rest breaks as needed
Conventional Therapy: : Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions; Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions
Other intervention name(s): HIT
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Baseline characteristics and training parameters (steps, intensity parameters) will be compared between treatment groups using independent group comparisons. (ANOVA, Kruskal-Wallis, or Chi-squared tests as appropriate).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; TBI; Walking