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Completed

NCT Number: NCT04503473

Locomotor Recovery Following Traumatic Brain Injury

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 6 months post traumatic brain injury
  • 18-75 years old
  • ability to walk without physical assistance
  • Self selected walking speed of 0.01-1.0 m/s

Exclusion criteria

  • <18 years old
  • >75 years old
  • self selected walking speed of > 1.0 m/s
  • < 3 months from botulinum toxin injection
  • Above the knee brace
  • Currently receiving physical therapy

Treatment and study plan

High Intensity Stepping Training

Behavioral

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

Other names: HIT

Conventional Therapy

Behavioral

Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions

Primary outcomes

  1. Change in Gait speed

    Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

    Gait speed is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait speed will be measured at self-selected speeds (SSS; instructions to "walk at normal comfortable pace") and fastest-possible speed (FS: "as fast as you safely can") using the Zeno Walkway (Protokinetics, Haverton, PA).

  2. Change in Endurance

    Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

    Endurance is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.

Secondary outcomes

  1. Change in Strength

    Time frame: Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 6 weeks

    • Peak volitional strength - We will assess strength while subjects are seated in an adjustable height chair of a testing apparatus. Three trials of peak isometric volitional hip, knee and ankle torques will be determined bilaterally with significant verbal encouragement for 3-5 sec, and > 1 min duration between trials.
  2. Change in gait quality

    Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

    Gait kinematics: Lower limb kinematics will be collected using an 8-camera motion capture system and 3-dimensional movement of 1" reflective markers affixed to the pelvis/legs. Spatiotemporal metrics will be extracted from the data, with primary measures of peak speed, stride length, cadence. All measures will be compared between fastest speeds achieved at BSL and POST, and at POST speeds matched to BSL peak speed to allow kinematic comparisons while controlling for speeds.

  3. Change in metabolic capacity

    Time frame: Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

    peak metabolic capacity will be observed during graded exercise testing on a treadmill wtih peak oxygen consumption

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: TBI_IU

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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