Clinical trial NCT02533037: Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability
Official title: Effects Of Rehabilitation Incorporating Gait Training On Clinical Measures Associated With Chronic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Ankle Instability
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaire
timeFrame: after 4-weeks of rehabilitation
Secondary outcomes:
measure: Changes from baseline in ankle range of motion measured in degrees
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in ankle maximum voluntary isometric strength
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in balance
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testing
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in lower extremity electromyography during balance
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in lower extremity kinematics during walking
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in lower extremity kinetics during walking
timeFrame: after 4-weeks of rehabilitation
measure: Changes from baseline in lower extremity surface electromyography during walking
timeFrame: after 4-weeks of rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Jay Hertel, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References: