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Completed

NCT Number: NCT02533037

Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability

This is a randomized controlled trial (RCT) regarding the conservative treatment of chronic ankle instability (CAI) with an impairment based rehabilitation program. Individuals with CAI have deficits in neuromuscular control and altered gait patterns. Ankle destabilization shoes are used clinically and may improve neuromuscular control by increasing lower extremity muscle activation, which may improve gait patterns. The investigators' purpose is to determine whether a 4-week rehabilitation program that includes ankle destabilization shoes (experimental) has beneficial effects on self-reported function and ankle gait kinematics compared to traditional rehabilitation without destabilization shoes (control) in CAI patients. In addition, the investigators will compare ankle strength and balance between CAI patients and healthy individuals with no history of ankle injury prior to the 4-week rehabilitation. The investigators hypothesize the experimental group will have greater improvement in self-reported function and frontal and sagittal plane kinematics during walking compared to the control group. In addition, the investigators hypothesize that patients with CAI will have a decrease in ankle strength and balance when compared to healthy individuals. The design is a single-blinded randomized controlled trial. Forty CAI patients will complete baseline self-reported function questionnaires and walking gait trials and then be randomized into control and experimental groups. Both groups will complete 4-weeks of supervised rehabilitation with or without destabilization shoes and then repeat the questionnaires and walking trials.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI
  • All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion criteria

  • Neurological or vestibular disorders affecting balance
  • Currently seeking medical care for CAI
  • History of prior ankle surgery
  • History of ankle sprain within the past 6 weeks
  • History of ankle fracture
  • Diabetes mellitus
  • Current self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
  • Lumbosacral radiculopathy
  • Pregnant
  • Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome

Treatment and study plan

Traditional Instability Tools

Other

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools.

Ankle Destabilization Shoes

Other

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes.

Primary outcomes

  1. Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire

    Time frame: after 4-weeks of rehabilitation

    Scores range from 100%(no decrease in function) to 0%(complete loss of function)

Secondary outcomes

  1. Changes from baseline in ankle range of motion measured in degrees

    Time frame: after 4-weeks of rehabilitation

    Four different ankle ranges of motion will be measured using a bubble inclinometer

  2. Changes from baseline in ankle maximum voluntary isometric strength

    Time frame: after 4-weeks of rehabilitation

    Ankle maximum voluntary isometric strength will be measured during five different ankle positions using a hand-held dynamometer.

  3. Changes from baseline in balance

    Time frame: after 4-weeks of rehabilitation

    Static balance will be measured by participants standing on one limb on a forceplate to measure the participant's center of pressure.

  4. Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testing

    Time frame: after 4-weeks of rehabilitation

    Lower extremity electormyography during maximal isometric strength testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.

  5. Changes from baseline in lower extremity electromyography during balance

    Time frame: after 4-weeks of rehabilitation

    Lower extremity electormyography during balance testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.

  6. Changes from baseline in lower extremity kinematics during walking

    Time frame: after 4-weeks of rehabilitation

    Ankle, knee, and hip motion during walking measured by a 3D motion capture system

  7. Changes from baseline in lower extremity kinetics during walking

    Time frame: after 4-weeks of rehabilitation

    Ankle, knee, and hip moments during walking measured by a 3D motion capture system

  8. Changes from baseline in lower extremity surface electromyography during walking

    Time frame: after 4-weeks of rehabilitation

    Lower extremity electormyography during walking will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 26, 2015
Registry last updated
Aug 26, 2015

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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