NCT04493645

Ankle Instability Using Foot Intensive Rehabilitation

Optimizing Clinical Outcomes for Patients With Chronic Ankle Instability Using Foot Intensive Rehabilitation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Matthew Hoch · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.

Detailed description

Lateral ankle sprains are one of the most common injuries sustained by the general population with the greatest rates in people who are physically active or service members. Approximately 40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by recurrent lateral ankle sprains, repetitive sensations of ankle "giving way", residual ankle sprain symptoms, and self-reported disability. Factors related to the development and progression of CAI has been thoroughly studied. However, few interventions have been developed which have successfully created long term reductions in re-injury rates, physical function, or health-related quality of life. Recent work by our research team has uncovered several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot function may contribute to the high re-injury rates, deficits in balance and strength, and diminished health-related quality of life commonly experienced by individuals with CAI. The investigators expect the additive effect of FIRE with components of the standard of care (balance training, strength training, and range of motion) will create the synergy needed to reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported disability in CAI patients (Aim 3).

Conditions

• Ankle Injuries
• Ankle Sprains

Interventions

Type	Name	Description
BEHAVIORAL	Standard of Care Rehabilitation (SOC)	6 weeks of standard of care rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.
BEHAVIORAL	Foot Intensive Rehabilitation (FIRE)	6 weeks of FIRE will be given along with elements of SOC. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.

Timeline

• Start date: 2021-10-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-07-30
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States