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NCT07860125

Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain

Sponsor: DITU Inc.

View on ClinicalTrials.gov

Summary

The goal of this study is to learn whether a 28-day home exercise program using the AxisBoard Single-Leg Balance Board improves ankle function in adults who are still having symptoms 6 weeks to 6 months after a lateral (outer) ankle sprain. The study will also look at the safety and ease of use of the AxisBoard. The main questions it aims to answer are: * Does ankle function in daily activities, measured with the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, improve from the start of the study to Day 28? * How do ankle pain, stability, balance, stiffness, strength, confidence, and return to activity change over the 28 days, and how satisfied are participants with the AxisBoard? There is no comparison group. Each participant's results will be compared with their own results at the start of the study. Participants will: * Complete screening and all study visits virtually, by video call, from home * Use the AxisBoard at home for 10 minutes once a day for 28 days, following a standardized exercise program * Complete a short daily electronic diary about pain, stiffness, ankle stability, and AxisBoard use * Attend virtual study visits at the start of the study and on Days 3, 7, 14, and 28 for questionnaires and recorded balance and movement tests

Official title: A Prospective, Single-Arm Study Evaluating the Safety, Effectiveness, and Usability of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01-04

Completion Date

2028-01-04

Last Updated

2026-10-06

Healthy Volunteers

Conditions

Ankle Sprains Lateral Ankle Sprain

Interventions

OTHER

AxisBoard Single-Leg Balance Board

The AxisBoard (DITU Inc., Alberta, Canada) is a single-leg balance-training board with a split forefoot and rearfoot base and stackable pegs that provide graded, targeted instability training of the ankle-stabilizing muscles. After virtual onboarding, participants use the AxisBoard at home for 10 minutes once daily for 28 consecutive days, following a standardized companion exercise program.

Inclusion Criteria: * Electronic informed consent provided before any study-specific screening procedure * Aged 18 to 70 years at the time of consent * Unilateral lateral ankle sprain occurring more than 6 weeks but less than 6 months before screening * Ankle sprain, as previously identified by the participant or a healthcare provider, confirmed through a standardized self-report history questionnaire and the Cumberland Ankle Instability Tool * Injury history consistent with a lateral ankle sprain, including: a lateral inversion (inward-rolling) injury mechanism; pain, swelling, and/or bruising over the lateral ankle at the time of injury; functional limitation immediately after the injury; and persistent symptoms at screening * Average activity-related pain of at least 3 out of 10 on the Numeric Pain Rating Scale during the previous 7 days * Able to safely perform the home-based AxisBoard program and virtual functional assessments according to study instructions * Body weight of 300 lb (136 kg) or less, and foot size within the range supported by the AxisBoard (women's size 7 to men's size 13, US sizing) * Access to a smartphone or other internet-enabled device suitable for virtual visits, electronic questionnaires, and video-conferencing functional assessments * Able and willing to complete the 28-day intervention, daily electronic diary, and scheduled study assessments Exclusion Criteria: * An injury requiring prolonged immobilization, surgical management, or intensive supervised rehabilitation * Suspected or confirmed syndesmotic (high) ankle sprain * Suspected or confirmed ankle or foot fracture, complete tendon rupture, or unresolved fracture red flags * Previous surgery on the affected ankle within 6 months before screening * Inflammatory arthritis affecting the lower extremities * Neurological disorders that may affect balance or safe performance of study procedures * Severe vestibular disorder or another condition associated with clinically important balance impairment * Intention or clinical requirement to begin a new supervised ankle rehabilitation program or another treatment after enrollment that is likely to affect study outcomes (stable background care may continue) * Any medical, physical, cognitive, or other condition that, in the investigator's judgment, would create an unacceptable risk, interfere with interpretation of study outcomes, or prevent completion of study procedures * Determined during screening to require an in-person clinical assessment to confirm eligibility (for example, because fracture or other serious pathology cannot be excluded through virtual assessment)