Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation

NCT03663361 | Recruiting

• 2 other identifiers: 44172DM170430
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankle Sprains

Keywords

ankle sprain, sensorimotor, rehabilitation, osteoarthritis

Outcome Measures

Primary Outcomes (15)

• Ankle re-injury rate

  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).

  12 months

• Change in mental quality of life

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in physical quality of life

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in physical activity

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in self-reported Functional Ankle Instability

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in self-reported Ankle Instability

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in self-reported Ankle Disability

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in dynamic balance

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in ankle dorsiflexion Range of Motion

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in corticomotor Excitability - Active Motor Threshold

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in corticomotor Excitability - Cortical Silent Period

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in Spinal Excitability

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in White Mater Structural Integrity

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in Ankle cartilage relaxation

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

• Change in Ankle Articular Cartilage Turnover

  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.

  rehabilitation discharge visit, 6 and 12 months post-discharge

Study Arms (2)

SMART Intervention

EXPERIMENTAL

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

Standard of Care Intervention

ACTIVE COMPARATOR

The Standard of Care intervention will include restoration of ankle joint range of motion, strength and functional movement.

Other: Standard of Care Intervention

Interventions

SMART Intervention OTHER

Ankle rehabilitation with the addition of sensorimotor components

SMART Intervention

Standard of Care Intervention OTHER

Ankle rehabilitation focused on restoring range of motion, strength and balance

Standard of Care Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phillip Gribble: lead
• United States Department of Defense: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Osteoarthritis

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Phillip Gribble, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Kosik, PhD

CONTACT

859-323-9850; kyle.kosik@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: September 10, 2018
• Study Start: November 12, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)