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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02533037
Enrollment
26
Registered
2015-08-26
Start date
2013-08-31
Completion date
2014-07-31
Last updated
2015-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Ankle Instability

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.

Interventions

OTHERTraditional Instability Tools

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.

OTHERAnkle Destabilization Shoes

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.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure questionnaireafter 4-weeks of rehabilitationScores range from 100%(no decrease in function) to 0%(complete loss of function)

Secondary

MeasureTime frameDescription
Changes from baseline in ankle maximum voluntary isometric strengthafter 4-weeks of rehabilitationAnkle maximum voluntary isometric strength will be measured during five different ankle positions using a hand-held dynamometer.
Changes from baseline in balanceafter 4-weeks of rehabilitationStatic balance will be measured by participants standing on one limb on a forceplate to measure the participant's center of pressure.
Changes from baseline in lower extremity electromyography during ankle maximal voluntary isometric strength testingafter 4-weeks of rehabilitationLower 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.
Changes from baseline in ankle range of motion measured in degreesafter 4-weeks of rehabilitationFour different ankle ranges of motion will be measured using a bubble inclinometer
Changes from baseline in lower extremity kinematics during walkingafter 4-weeks of rehabilitationAnkle, knee, and hip motion during walking measured by a 3D motion capture system
Changes from baseline in lower extremity kinetics during walkingafter 4-weeks of rehabilitationAnkle, knee, and hip moments during walking measured by a 3D motion capture system
Changes from baseline in lower extremity surface electromyography during walkingafter 4-weeks of rehabilitationLower extremity electormyography during walking will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.
Changes from baseline in lower extremity electromyography during balanceafter 4-weeks of rehabilitationLower extremity electormyography during balance testing will be measured using surface EMG electrodes over the peroneus brevis, peroneus longus, anterior tibialis, and medial gastrocnemius muscles.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026