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Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation

ConditionAnkle Sprains
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-44
SponsorPhillip Gribble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART Intervention

    Other intervention

    Ankle rehabilitation with the addition of sensorimotor components

  • Standard of Care Intervention

    Other intervention

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: SMART InterventionExperimental treatment 1 intervention
Group B: Standard of Care InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 months
2

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.

Time frame
rehabilitation discharge visit, 6 and 12 months post-discharge
3

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.

Time frame
rehabilitation discharge visit, 6 and 12 months post-discharge
4

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.

Time frame
rehabilitation discharge visit, 6 and 12 months post-discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phillip Gribble

Lead sponsor

University of Kentucky

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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