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Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663361
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Phillip Gribble, University of Kentucky

Brief Summary:
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers.

Condition or disease Intervention/treatment Phase
Ankle Sprains Other: SMART Intervention Other: Standard of Care Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: SMART Intervention
The SMART intervention will utilize the elements of the Standard of Care intervention, and will also include "Sensorimotor Improvements" and other specific additions that will focus on sensory inputs, motor outputs, and integration of the sensory and motor pathways.
Other: SMART Intervention
Ankle rehabilitation with the addition of sensorimotor components

Active Comparator: Standard of Care Intervention
The Standard of Care intervention will include restoration of ankle joint range of motion, strength and functional movement.
Other: Standard of Care Intervention
Ankle rehabilitation focused on restoring range of motion, strength and balance




Primary Outcome Measures :
  1. Ankle re-injury rate [ Time Frame: 12 months ]
    The number of patient reported re-sprains of the ankle. The outcomes will be assessed at 12 months post-rehabilitation discharge (ie. return to activity).

  2. Change in mental quality of life [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as the sum total from 8 questions. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  3. Change in physical quality of life [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as the sum total from 8 questions . Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  4. Change in physical activity [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a score from 0-10, with 10 being the highest level of self-reported physical activity. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  5. Change in self-reported Functional Ankle Instability [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a score from 0-37 on the Identification of Functional Ankle Instability (IdFAI), with 0 indicating no self-reported ankle instability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  6. Change in self-reported Ankle Instability [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a score from 0-5 on the Ankle Instability Instrument (AII), with 0 indicating no self-reported ankle instability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  7. Change in self-reported Ankle Disability [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a percentage score from 0-100% on the Foot and Ankle Ability Measure (FAAM), with 100% indicating no self-reported ankle disability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  8. Change in dynamic balance [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are reported as linear reach distance normalized to leg length, which are presented as a percentage score, with higher percentage scores representing better dynamic balance. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  9. Change in ankle dorsiflexion Range of Motion [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a linear distance with larger values representing more estimated joint range of motion. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  10. Change in corticomotor Excitability - Active Motor Threshold [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented in millivolts with a higher number representing a lower level of cortical excitability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  11. Change in corticomotor Excitability - Cortical Silent Period [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a time value in milliseconds with a higher number representing a lower level of cortical excitability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  12. Change in Spinal Excitability [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a ratio with a smaller ratio representing a lower level of spinal excitability. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  13. Change in White Mater Structural Integrity [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a scalar value ranging from 0-1.0 with lower values representing a greater loss of white mater structural integrity. Group means and standard deviations will be reported. TThe outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  14. Change in Ankle cartilage relaxation [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    T1rho -magnetic resonance imaging of the superior aspect of the talus in the ankle will be performed. Participant images will be assessed by a blinded observer and scored as a the amount of time required to achieve relaxation. The data are presented in milliseconds. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.

  15. Change in Ankle Articular Cartilage Turnover [ Time Frame: rehabilitation discharge visit, 6 and 12 months post-discharge ]
    Data are presented as a time value in seconds with longer values representing a greater amount of articular cartilage turnover. Group means and standard deviations will be reported. The outcomes will be assessed at the rehabilitation discharge visit and 6 and 12 months post-discharge and reported as change scores over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • initiating rehabilitation for a first time acute grade I, II, or III LAS
  • have sustained within 72 hours of study enrollment
  • diagnosed by a physician, medic, athletic trainer, physical therapist, or other providing medical coverage in operational environments as having sustained a LAS

Exclusion Criteria:

  • personal or familial history of epilepsy or seizures
  • history of migraine headaches
  • ocular foreign body, increased intracranial pressure, open head injury or significant closed head injury
  • cochlear implants
  • implanted brain stimulators, aneurysm clips or other metal in the head (except mouth)
  • implanted medication pumps, pacemakers or intracardiac lines
  • current medication with tricyclic anti-depressants, neuroleptic agents or other drugs that lower seizure threshold
  • history of diagnosed major psychiatric disorder
  • history of illicit drug use
  • current alcohol abuse or currently withdrawing from alcohol abuse
  • history of heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663361


Contacts
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Contact: Kyle Kosik, PhD 859-323-9850 kyle.kosik@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Meaghan Beck    859-323-9850    meaghan.beck@uky.edu   
Principal Investigator: Phillip Gribble, PhD         
Sub-Investigator: John Abt, PhD         
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Erik Wikstrom, PhD    919-962-2260    wikstrom@unc.edu   
United States, Texas
William Beaumont Army Medical Center Not yet recruiting
El Paso, Texas, United States, 79920
Contact: Gary Helton, CPT       gary.l.helton8.mil@mail.mil   
Sponsors and Collaborators
Phillip Gribble
United States Department of Defense
Investigators
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Principal Investigator: Phillip Gribble, PhD University of Kentucky
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Responsible Party: Phillip Gribble, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03663361    
Other Study ID Numbers: 44172
DM170430 ( Other Grant/Funding Number: US Army Medical Research Acquisition Activity (USAMRAA) )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phillip Gribble, University of Kentucky:
ankle sprain, sensorimotor, rehabilitation, osteoarthritis
Additional relevant MeSH terms:
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Ankle Injuries
Wounds and Injuries
Leg Injuries