Ankle SprainsNCT07860125
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
A study testing AxisBoard Single-Leg Balance Board in people with Ankle Sprains and Lateral Ankle Sprain, run by DITU Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Sprains, Lateral Ankle Sprain
- What is being tested?
- AxisBoard Single-Leg Balance Board
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 4 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
- 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
Read the detailed description
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.
Intervention: 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.
Procedures: 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.
Analysis: 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.
Each 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.
- Conditions
- Ankle Sprains, Lateral Ankle Sprain
- Being tested
- AxisBoard Single-Leg Balance Board
- Keywords
- Balance Training, Home-Based Rehabilitation, Decentralized Clinical Trial, Wobble Board
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxisBoard Single-Leg Balance BoardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AxisBoard Single-Leg Balance Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Day 28 (±3 days)
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.
Measured: Baseline (Day 0) to Day 28 (±3 days)
Secondary outcomes (17)
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.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±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.
Measured: Day 28 (±3 days)
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.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Daily, Day 1 to Day 28
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.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Self-Rated Ankle Strength
Participant self-rating of affected-ankle strength.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Confidence With Stairs and Squatting
Participant-rated confidence when using stairs and when squatting.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Baseline (Day 0), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Proportion of Participants Returning to Unrestricted Activity or Sport
Participant-reported return to unrestricted activity or sport.
Measured: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
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.
Measured: Day 7 (±1 day)
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.
Measured: Day 28 (±3 days)
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.
Measured: Day 28 (±3 days)
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.
Measured: Day 1 to Day 28
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.
Measured: From informed consent through Day 28 (±3 days) or withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start4 Jan 2027 (estimated)
- Primary completion4 Jan 2028 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DITU Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860125
- Sponsor's protocol ID
- DITU-AXB-LAS-001
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study data and functional-assessment videos will be used only for the conduct, analysis, reporting, monitoring, and audit of this study and will not be placed in a repository or made available for other research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07860125
- Acronym / sponsor ID
- DITU-AXB-LAS-001
- Conditions
- Ankle Sprains, Lateral Ankle Sprain
- Keywords
- Balance Training, Home-Based Rehabilitation, Decentralized Clinical Trial, Wobble Board
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- DITU Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 4 Jan 2028 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Intervention: 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.
Procedures: 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.
Analysis: 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.
Each 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AxisBoard Home Program | Experimental | Other: AxisBoard Single-Leg Balance BoardAdults 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AxisBoard Single-Leg Balance BoardThe 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. | Other | AxisBoard Home Program |
Primary outcome
Change in Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Subscale Score
Time frame: Baseline (Day 0) to Day 28 (±3 days)
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.
Proportion of Participants Achieving the FAAM-ADL Minimal Clinically Important Difference
Time frame: Baseline (Day 0) to Day 28 (±3 days)
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 secondary outcomes
Change in Activity-Related Ankle Pain (Numeric Pain Rating Scale)
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Global Rating of Change (GROC)
Time frame: Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Proportion of Participants Reporting an Acceptable Symptom State (PASS)
Time frame: Day 28 (±3 days)
Change in Affected-Ankle Cumberland Ankle Instability Tool (CAIT) Score
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Number of Ankle Giving-Way Episodes
Time frame: Daily, Day 1 to Day 28
Change in Single-Leg Stance Time
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Ankle Dorsiflexion Range of Motion (Weight-Bearing Lunge Test)
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Ankle Stiffness (Numeric Rating Scale)
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Self-Rated Ankle Strength
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Confidence With Stairs and Squatting
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Change in Foot and Ankle Ability Measure Sports Subscale (FAAM Sports) Score
Time frame: Baseline (Day 0), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Proportion of Participants Returning to Unrestricted Activity or Sport
Time frame: Baseline (Day 0), Day 3 (±1), Day 7 (±1), Day 14 (±2), and Day 28 (±3)
Early Ease of Use of the AxisBoard
Time frame: Day 7 (±1 day)
System Usability Scale (SUS) Score
Time frame: Day 28 (±3 days)
Net Promoter Score (NPS)
Time frame: Day 28 (±3 days)
Adherence to the AxisBoard Program
Time frame: Day 1 to Day 28
Number of Participants With Adverse Events, Including Tool-Related Adverse Events
Time frame: From informed consent through Day 28 (±3 days) or withdrawal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study data and functional-assessment videos will be used only for the conduct, analysis, reporting, monitoring, and audit of this study and will not be placed in a repository or made available for other research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AxisBoard Single-Leg Balance Board in people with Ankle Sprains and Lateral Ankle Sprain, run by DITU Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hin Lai (780-709-1934, info@sidekicktool.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Subscale Score (time frame: Baseline (Day 0) to Day 28 (±3 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.