Table 1 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov NCT04493645 |
Date of registration in primary registry | 30 July 2020 |
Secondary identifying numbers | 58,500; CDMRP-OR190060 (Other Grant/Funding Number: Department of Defense) |
Source(s) of monetary or material support | Congressionally Directed Medical Research Programs |
Primary sponsor | Congressionally Directed Medical Research Programs |
Secondary sponsor(s) | NA |
Contact for public queries | Douglas Long, MS, 859–323-5438, delong2@uky.edu; Matthew Hoch, PhD, ATC, 859–323-9850, matt.hoch@uky.edu |
Contact for scientific queries | Matthew Hoch, PhD, ATC, Sports Medicine Research Institute, University of Kentucky |
Public title | Ankle Instability Using Foot Intensive Rehabilitation |
Scientific title | Optimizing Clinical Outcomes for Patients with Chronic Ankle Instability Using Foot Intensive Rehabilitation |
Countries of recruitment | United States |
Health condition(s) or problem(s) studied | Ankle Injuries; Ankle Sprains |
Intervention(s) | Active comparator: Foot Intensive Rehabilitation (FIRE) and Standard of Care Rehabilitation (SOC). 6Â weeks of FIRE will be given along with elements of SOC. Each patient will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week |
Control comparator: Standard of Care Rehabilitation. 6Â weeks of SOC rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each patient will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week | |
Key inclusion and exclusion criteria | Ages eligible for study: 18 to 44Â years; Sexes eligible for study: both; Accepts healthy volunteers: no |
Inclusion criteria: Aged 18–44; Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months; Patients must answer "yes" to at least 5 questions on the Ankle Instability Instrument; Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI); Confirmed clinical presentation of CAI by a PT, AT, or MD | |
Exclusion criteria: Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12Â months; History of surgery to the lower extremity; Sustained a lower extremity fracture; History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance; Current participation in a formal ankle joint rehabilitation program; Sustained a concussion in the last 12Â months; Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity) | |
Study type | Allocation: Randomized; Intervention Model: Parallel Assignment; Intervention Model Description:The investigators will compare clinical and innovative outcome measures collected at five time points between cohorts of patients with CAI that receive a standard of care (SOC) rehabilitation program compared to an innovative foot intensive rehabilitation (FIRE) program to determine if FIRE can further reduce the rate of re-injury, improve sensorimotor function, and reduce self-reported disability during the 24Â months following the intervention.; Masking: Single (Outcomes Assessor); Masking Description: The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment. Primary Purpose: Treatment |
Date of first enrolment | October 2021 |
Target sample size | 150 |
Recruitment status | Recruiting |
Primary outcome(s) | Number of recurrent ankle sprains [Time Frame: 24 months]: The ability of FIRE to attenuate the occurrence of ankle sprains compared to SOC rehabilitation will be determined through self-report. An ankle sprain will be operationally defined as an incident in which the rearfoot was inverted or supinated and resulted in a combination of swelling, pain, and time lost or modification of normal function for at least one day Frequency of episodes of the ankle giving way [Time Frame: 24 months]: The ability of FIRE to attenuate the number of episodes of the ankle giving way compared to SOC rehabilitation will be determined through self-reported occurrences per week in the past month. Episodes of giving way will be operationally defined for the patient as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and was able to continue with normal function Severity of chronic ankle instability related symptoms [Time Frame: 24 months]: The ability of FIRE to attenuate the severity of related symptoms compared to SOC rehabilitation will be determined through the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a 9-item instrument used to identify self-reported impairments associated with CAI. This instrument is scored on a 0–30 scale, where lower scores represent greater severity of CAI related symptoms |
Key secondary outcomes | Postural Control [Time Frame: 12 months]: The ability of FIRE to improve static and dynamic postural control compared to SOC rehabilitation will be determined. Multiple measurements will be made including: Single-limb stance on each limb with eyes open and eyes closed with use of a force plate for center of pressure measurements, Star Excursion Balance Test, forward jump single limb landing stabilization task. All measurements will be monitored while the patient wears an inertial sensor placed on the lumbar spine Ankle/Toe Strength [Time Frame: 12 months]: The ability of FIRE to improve strength compared to SOC rehabilitation will be determined. Strength of the muscles surrounding the ankle and the toes will be assessed through a series of assessments with a digital handheld dynamometer Intrinsic Foot Muscle Activation [Time Frame: 12 months]: The ability of FIRE to improve foot muscle activation compared to SOC rehabilitation will be determined. Abductor hallucis, flexor digitorum brevis, quadratus plantae, and flexor hallucis brevis functional activity ratios will be captured using diagnostic ultrasound with a 12–4 MHz linear array transducer probe and measured using Image J software Plantar Cutaneous Sensation [Time Frame: 12 months]: The ability of FIRE to improve plantar cutaneous sensation compared to SOC rehabilitation will be determined. Plantar cutaneous sensation will be tested using a 20-piece Semmes–Weinstein Monofilament kit which has monofilaments ranging from to 0.008 g of force (1.65 level) to 300 g of force (6.65 level). Light touch detection thresholds will be assessed on the plantar surface at the 1st metatarsal head |