[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659165":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":88,"studyPopulation":85,"armGroups":89,"interventions":96,"overallOfficials":85,"centralContacts":102,"locations":85,"responsibleParty":108,"collaborators":85,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":85,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":85,"studyType":123,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":134,"whyStopped":85,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":85},{"fullName":5,"class":6},"DITU Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":76},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline (Day 0) to Day 28 (±3 days)",{"measure":14,"description":15,"timeFrame":12},"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.",[17,21,25,29,32,36,39,42,45,48,51,55,58,62,65,68,72],{"measure":18,"description":19,"timeFrame":20},"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.","Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)",{"measure":22,"description":23,"timeFrame":24},"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.","Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)",{"measure":26,"description":27,"timeFrame":28},"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.","Day 28 (±3 days)",{"measure":30,"description":31,"timeFrame":20},"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.",{"measure":33,"description":34,"timeFrame":35},"Number of Ankle Giving-Way Episodes","Number of episodes in which the affected ankle unexpectedly rolled, buckled, or gave way, as reported in the daily electronic diary. Perceived ankle stability is also recorded daily.","Daily, Day 1 to Day 28",{"measure":37,"description":38,"timeFrame":20},"Change in Single-Leg Stance Time","Time in seconds the participant can stand on the affected leg, measured during video visits and scored centrally by trained raters using a standardized rubric.",{"measure":40,"description":41,"timeFrame":20},"Change in Ankle Dorsiflexion Range of Motion (Weight-Bearing Lunge Test)","Ankle dorsiflexion measured with the weight-bearing knee-to-wall lunge test during video visits and scored centrally by trained raters using a standardized rubric.",{"measure":43,"description":44,"timeFrame":20},"Change in Ankle Stiffness (Numeric Rating Scale)","Ankle stiffness rated on an 11-point Numeric Rating Scale from 0 (no stiffness) to 10 (worst stiffness imaginable). Stiffness is also recorded in the daily electronic diary on Days 1 to 28.",{"measure":46,"description":47,"timeFrame":20},"Change in Self-Rated Ankle Strength","Participant self-rating of affected-ankle strength.",{"measure":49,"description":50,"timeFrame":20},"Change in Confidence With Stairs and Squatting","Participant-rated confidence when using stairs and when squatting.",{"measure":52,"description":53,"timeFrame":54},"Change in Foot and Ankle Ability Measure Sports Subscale (FAAM Sports) Score","Among participants engaged in sport, the FAAM Sports subscale assesses higher-demand activities. Scores are expressed as a percentage from 0% to 100%, where higher scores indicate better function.","Baseline (Day 0), Day 7 (±1), Day 14 (±2), and Day 28 (±3)",{"measure":56,"description":57,"timeFrame":20},"Proportion of Participants Returning to Unrestricted Activity or Sport","Participant-reported return to unrestricted activity or sport.",{"measure":59,"description":60,"timeFrame":61},"Early Ease of Use of the AxisBoard","Brief questionnaire assessing ease of setup, ease of learning, confidence using the AxisBoard, and overall ease of use.","Day 7 (±1 day)",{"measure":63,"description":64,"timeFrame":28},"System Usability Scale (SUS) Score","The SUS is a 10-item standardized usability questionnaire scored from 0 to 100, where higher scores indicate better usability.",{"measure":66,"description":67,"timeFrame":28},"Net Promoter Score (NPS)","Participant likelihood of recommending the AxisBoard, rated from 0 to 10 and summarized as a Net Promoter Score from -100 to +100.",{"measure":69,"description":70,"timeFrame":71},"Adherence to the AxisBoard Program","Cumulative AxisBoard minutes completed, expressed as a percentage of the 280 planned minutes, recorded in the daily electronic diary. Completed, partial, and missed sessions, use interruptions, and program modifications are summarized separately.","Day 1 to Day 28",{"measure":73,"description":74,"timeFrame":75},"Number of Participants With Adverse Events, Including Tool-Related Adverse Events","Incidence, frequency, nature, severity, seriousness, relationship to the AxisBoard, action taken, and outcome of adverse events. Other safety data include pain exacerbations, falls or near-falls, skin irritation, loss of balance, AxisBoard deficiencies or malfunctions, use interruptions, discontinuations, and clinical referrals.","From informed consent through Day 28 (±3 days) or withdrawal",[77],{"measure":78,"description":79,"timeFrame":24},"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.",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":85,"timePerspective":85,"maskingInfo":86},"NA","SINGLE_GROUP","Prospective, single-arm, open-label, decentralized study. All participants use the AxisBoard at home for 10 minutes once daily for 28 days. Each participant serves as their own baseline control; there is no concurrent comparator.","TREATMENT",null,{"masking":87,"maskingDescription":85,"whoMasked":85},"NONE","This is a prospective, single-arm, open-label, decentralized study conducted in Canada. Approximately 80 adults aged 18 to 70 years with a unilateral lateral ankle sprain that occurred more than 6 weeks but less than 6 months before screening, and with average activity-related ankle pain of at least 3 out of 10 over the previous 7 days, will be enrolled.\n\nIntervention: 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. Participants complete virtual onboarding and then use the AxisBoard at home for 10 minutes once daily for 28 consecutive days, following a standardized companion exercise program (280 planned minutes in total). Stable background care may continue, but participants may not start a new ankle rehabilitation program or another treatment likely to affect study outcomes after enrollment.\n\nProcedures: Screening, electronic informed consent, onboarding, and all assessments are conducted remotely using standardized scripts. Visits occur at Screening (Day -14 to Day -1), Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3). Participants complete a daily electronic diary (Days 1 to 28) covering activity-related pain, analgesic use, stiffness, perceived stability, ankle giving-way episodes, and AxisBoard use. Functional assessments (single-leg stance and the weight-bearing lunge dorsiflexion test) are recorded during video visits and scored centrally by trained raters using a standardized rubric, blinded to prior scores where feasible.\n\nAnalysis: The primary endpoint is the change in FAAM-ADL score from Baseline to Day 28, with a responder analysis based on the minimal clinically important difference of approximately 8 points. Secondary endpoints address pain, perceived recovery, ankle instability, balance, dorsiflexion range of motion, stiffness, strength, confidence, sport function, return to activity, usability, satisfaction, adherence, and safety. Adverse events are collected from informed consent through Day 28 or withdrawal.\n\nEach participant serves as their own baseline control. The study has no concurrent comparator, randomization, placebo, or formal blinding, and it is not designed to show superiority or non-inferiority to another treatment.",[90],{"label":91,"type":92,"description":93,"interventionNames":94},"AxisBoard Home Program","EXPERIMENTAL","Adults with a lateral ankle sprain that occurred more than 6 weeks but less than 6 months before screening use the AxisBoard at home for 10 minutes once daily for 28 consecutive days, following a standardized companion exercise program, with virtual assessments at Baseline and on Days 3, 7, 14, and 28.",[95],"Other: AxisBoard Single-Leg Balance Board",[97],{"type":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":85},"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.",[91],[103],{"name":104,"role":105,"phone":106,"phoneExt":85,"email":107},"Hin Lai","CONTACT","780-709-1934","info@sidekicktool.com",{"type":109,"investigatorFullName":85,"investigatorTitle":85,"investigatorAffiliation":85,"oldNameTitle":85,"oldOrganization":85},"SPONSOR","100659165","study-of-the-axisboard-single-leg-balance-board-in-adults-with-lateral-ankle-sprain-100659165",false,"NCT07860125","Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain","A Prospective, Single-Arm Study Evaluating the Safety, Effectiveness, and Usability of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain","Inclusion Criteria:\n\n* Electronic informed consent provided before any study-specific screening procedure\n* Aged 18 to 70 years at the time of consent\n* Unilateral lateral ankle sprain occurring more than 6 weeks but less than 6 months before screening\n* 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\n* Injury history consistent with a lateral ankle sprain, including: a lateral inversion (inward-rolling) injury mechanism; pain, swelling, and\u002For bruising over the lateral ankle at the time of injury; functional limitation immediately after the injury; and persistent symptoms at screening\n* Average activity-related pain of at least 3 out of 10 on the Numeric Pain Rating Scale during the previous 7 days\n* Able to safely perform the home-based AxisBoard program and virtual functional assessments according to study instructions\n* 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)\n* Access to a smartphone or other internet-enabled device suitable for virtual visits, electronic questionnaires, and video-conferencing functional assessments\n* Able and willing to complete the 28-day intervention, daily electronic diary, and scheduled study assessments\n\nExclusion Criteria:\n\n* An injury requiring prolonged immobilization, surgical management, or intensive supervised rehabilitation\n* Suspected or confirmed syndesmotic (high) ankle sprain\n* Suspected or confirmed ankle or foot fracture, complete tendon rupture, or unresolved fracture red flags\n* Previous surgery on the affected ankle within 6 months before screening\n* Inflammatory arthritis affecting the lower extremities\n* Neurological disorders that may affect balance or safe performance of study procedures\n* Severe vestibular disorder or another condition associated with clinically important balance impairment\n* 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)\n* 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\n* 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)","ALL","18 Years","70 Years",{"count":121,"type":122},80,"ESTIMATED","INTERVENTIONAL",[81],"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.\n\nThe main questions it aims to answer are:\n\n* 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?\n* 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?\n\nThere is no comparison group. Each participant's results will be compared with their own results at the start of the study.\n\nParticipants will:\n\n* Complete screening and all study visits virtually, by video call, from home\n* Use the AxisBoard at home for 10 minutes once a day for 28 days, following a standardized exercise program\n* Complete a short daily electronic diary about pain, stiffness, ankle stability, and AxisBoard use\n* 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",[127,128],"Ankle Sprains","Lateral Ankle Sprain",[130,131,132,133],"Balance Training","Home-Based Rehabilitation","Decentralized Clinical Trial","Wobble Board","NOT_YET_RECRUITING","2026-10-01",{"date":137,"type":138},"2026-10-06","ACTUAL",{"date":140,"type":122},"2027-01-04",{"date":142,"type":122},"2028-01-04",{"name":5,"class":6}]