Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDITU Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
AxisBoard Single-Leg Balance Board
Other interventionThe 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: AxisBoard Home ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Subscale Score
The FAAM-ADL is a validated, patient-reported measure of ankle-related limitations in daily activities such as standing, walking, using stairs, and squatting. Scores are expressed as a percentage from 0% to 100%, where higher scores indicate better function. FAAM-ADL scores are also recorded at Day 7 and Day 14 to describe the trajectory of change.
Time frame
Baseline (Day 0) to Day 28 (±3 days)2
Proportion of Participants Achieving the FAAM-ADL Minimal Clinically Important Difference
Proportion of participants with an improvement of approximately 8 points or more from baseline in FAAM-ADL score, representing the reported minimal clinically important difference.
Time frame
Baseline (Day 0) to Day 28 (±3 days)Secondary outcomes
1
Change in Activity-Related Ankle Pain (Numeric Pain Rating Scale)
Activity-related ankle pain rated on an 11-point Numeric Pain Rating Scale from 0 (no pain) to 10 (worst pain imaginable). Daily pain and analgesic use are also recorded in the electronic diary on Days 1 to 28.
Time frame
Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)2
Global Rating of Change (GROC)
Participant-rated overall change in the ankle condition since the start of the study, measured with the Global Rating of Change scale.
Time frame
Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)3
Proportion of Participants Reporting an Acceptable Symptom State (PASS)
Proportion of participants who consider their current ankle symptom state acceptable, measured using the Patient Acceptable Symptom State question.
Time frame
Day 28 (±3 days)4
Change in Affected-Ankle Cumberland Ankle Instability Tool (CAIT) Score
The CAIT is a validated questionnaire on perceived ankle instability, scored from 0 to 30, where lower scores indicate greater instability. The bilateral format is administered and only the affected-ankle score is analyzed.
Time frame
Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)Other outcomes
1
Time to Earliest Clinically Meaningful Improvement
The first post-baseline visit at which a participant meets at least one responder criterion: a reduction of at least 2 points in NPRS pain, an improvement of approximately 8 points or more in FAAM-ADL score (first evaluated at Day 7), or a GROC rating of "Much Improved" or better.
Time frame
Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)Locations
Source ClinicalTrials.gov
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