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

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University of Virginia

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Ankle Instability

Treatments

Other: Ankle Destabilization Shoes
Other: Traditional Instability Tools

Study type

Interventional

Funder types

Other

Identifiers

NCT02533037
16992 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Traditional Instability Tools
Active Comparator group
Description:
Participants will use traditional instability tools during the impairment-based rehabilitation intervention.
Treatment:
Other: Traditional Instability Tools
Ankle destabilization shoes
Experimental group
Description:
Participants will use ankle destabilization shoes during the impairment-based rehabilitation intervention.
Treatment:
Other: Ankle Destabilization Shoes

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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