Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04503473 |
| Other study ID # |
1911962819 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
