Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04503473
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2019-12-16
Brief Title:
Locomotor Recovery Following Traumatic Brain Injury
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Locomotor Recovery Following Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBI_IU
Brief 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 ie 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 ie 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 ie 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 ie 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 in1 greater locomotor gains as compared to non-specific interventions 2 gains in selected impairments underlying gait dysfunction ie 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
Central hypotheses are that stepping training in TBI results in1 greater locomotor gains as compared to non-specific interventions 2 gains in selected impairments underlying gait dysfunction ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None