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

NCT02533037 | Completed Phase 2

• 1 other identifier: 16992
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

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

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

  after 4-weeks of rehabilitation

Secondary Outcomes (8)

• Changes from baseline in ankle range of motion measured in degrees

  after 4-weeks of rehabilitation

• Changes from baseline in ankle maximum voluntary isometric strength

  after 4-weeks of rehabilitation

• Changes from baseline in balance

  after 4-weeks of rehabilitation

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

  after 4-weeks of rehabilitation

• Changes from baseline in lower extremity electromyography during balance

  after 4-weeks of rehabilitation

Study Arms (2)

Traditional Instability Tools

ACTIVE COMPARATOR

Participants will use traditional instability tools during the impairment-based rehabilitation intervention.

Other: Traditional Instability Tools

Ankle destabilization shoes

EXPERIMENTAL

Participants will use ankle destabilization shoes during the impairment-based rehabilitation intervention.

Other: Ankle Destabilization Shoes

Interventions

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.

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.

Ankle destabilization shoes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Officials

• Jay Hertel, PhD, ATC

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Kinesiology

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2015

Record last verified: 2015-08