Instability; Ankle (Ligaments) (Old Injury)ROCKY REHABNCT04999904
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
A study testing Uneven Treadmill Intervention in people with Instability; Ankle (Ligaments) (Old Injury) and Sprain of Ankle, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial summary
The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Instability; Ankle (Ligaments) (Old Injury), Sprain of Ankle
- What is being tested?
- Uneven Treadmill Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Nov 2021to 30 Sep 2026
- 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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-49.
- Score < 24 on the Cumberland Ankle Instability Tool.
- Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation.
- Able to attend treatment sessions for approximately a 6-week period.
- Passed most recent physical fitness test (Active duty only).
- Acute lateral ankle sprain specific inclusion criteria:
Show all 13Show fewer
- history of a first-time ankle sprain that resulted in activity limitation that lasted at least one day.
- chronicity of 2-6 weeks prior to consent.
- Chronic ankle instability specific inclusion criteria:
- history of at least one significant ankle sprain within the 12 months prior to enrollment that interrupted physical activity for 1+ days.
- most recent ankle sprain in the past 2-12 weeks.
- history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or ''feelings of instability.''
- Individual is about to start care with physical therapy.
Who cannot join
- Unable to walk at the point of study enrollment.
- Non-removable casting.
- History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves).
- History of fracture in either limb of the lower extremity requiring realignment.
- Acute injury to musculoskeletal structures of other joints of the lower extremity within the previous three months, which impacted joint integrity and function resulting in at least one interrupted day of physical activity.
- Pregnant.
Show all 9Show fewer
- Self-reported disability due to neuromuscular impairment in the lower extremity, neurological or vestibular impairment that affected balance.
- Connective tissue disorder (e.g. Marfan Syndrome or Ehlers-Danlos syndrome).
- Anyone separating from the military within 12 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Naval Hospital Camp Pendelton
Oceanside, California, 92055
Brian Green, PhD, 814-574-6049, brian.s.green38.ctr@mail.mil
- Recruiting
Naval Medical Center San Diego
San Diego, California, 92134
Emma Beisheim-Ryan, PT, DPT, PhD, 585-975-9644, emma.h.beisheim-ryan.civ@health.mil
Emma Beisheim-Ryan, PT, DPT, PhD
About this study
The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability.
Read the detailed description
Lower limb sprains and strains are three-times more prevalent than any other acute injury in the Armed Forces, with lateral ankle sprains being the most common injury sustained during active-duty. Many individuals who experience an ankle sprain will go on to develop chronic ankle instability. Training and rehabilitation programs that incorporate proprioceptive training are particularly effective at improving outcomes and reducing re-injury rate. However, current programs do not help individuals "train to the tasks" that will be encountered once those individuals leave physical therapy. The proposed intervention evaluates the use of a rocky, uneven terrain treadmill that specifically targets aspects of the real-world environment for restoring and improving short-term function and performance and reducing the long-term risk of re-injury. This trial will randomly allocate 312 individuals with ankle sprains and chronic ankle instability to standard of care physical therapy or the standard of care supplemented with the uneven treadmill intervention. Patient reported outcome, performance measures, and biomechanical measures of muscle activations and plantar pressures will be evaluated. Patient reported outcomes and reinjury rates will be tracked for 18 months.
- Being tested
- Uneven Treadmill Intervention, Standard of Care Physical Therapy
- Keywords
- Acute Ankle Sprain, Chronic Ankle Instability, Proprioceptive Training, Uneven Treadmill, Reinjury, Rehabilitation, Service Members
- Medical subject headings
- Ankle Injuries, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uneven Treadmill InterventionOther
Progressive proprioceptive training on the uneven treadmill with up to twelve training sessions. Subjects will be advanced through activities with progression pragmatically assessed by the physical therapists for the benefit and tolerance of the individual subject. Activities may include: slow walking, fast walking, inclined/declined walking, head turning, vision obstruction, dual task walking, fatigued walking, load carriage. Standard of care physical therapy is still provided.
Standard of Care Physical TherapyOther
Standard of Care Physical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Uneven Treadmill Arm | Experimental | Uneven Treadmill Intervention with up to twelve sessions over approximately six weeks and Standard of Care Physical Therapy with an 18 month follow-up period Receives: Other: Uneven Treadmill Intervention |
| Control Arm | Active comparator | Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period Receives: Other: Standard of Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Cumberland Ankle Instability Tool
The Cumberland Ankle Instability Tool is a 9-item questionnaire, 30 points max score, with higher scores indicating better function. The Cumberland Ankle Instability Tool evaluates the severity of ankle instability during sport and activities of daily living, as well as pain.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
The Foot and Ankle Ability Measure: Activities of Daily Living subscale is a 21-item questionnaire with 84 points max, with higher scores indicating better function. The Activities of Daily Living Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during activities of daily living.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Foot and Ankle Ability Measure, Sports Subscale
The Foot and Ankle Ability Measure: Sports subscale is a 8-item questionnaire with 32 points max, with higher scores indicating better function. The Sports Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during recreational/sport activities.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Secondary outcomes (11)
Change in the Lower Extremity Functional Scale
The Lower Extremity Functional Scale is a 20-item questionnaire with 80 points max, with higher scores indicating better function. The Lower Extremity Functional Scale is used for individuals with lower extremity musculoskeletal disorders and assesses activity limitations and participation restrictions.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a 11-item questionnaire with scores between 11 and 44 points, with higher scores indicating greater kinesiophobia. The Tampa Scale of Kinesiophobia is used to assess subjective ratings of fear-related concepts.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Numeric Pain Rating Scale
The Numeric Pain Rating Scale is a 4-item questionnaire with scores between 0 and 40 points, with higher scores indicating greater pain. In the Numeric Pain Rating Scale subjects select a value that is most in line with the intensity of pain they have experienced in the past 24 hours.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Godin Leisure-Time Physical Activity Questionnaire
The Godin Leisure-Time Physical Activity Questionnaire measures the number of instances where subjects engaged in mild, moderate, and strenuous physical activity for greater than 15 minutes. Modified to account over the previous week rather than a typical week. Higher scores indicate more physical activity where 3, 5, and 9 points are given for each time a mild, moderate, or strenuous activity is engaged.
Measured: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Y Balance Test
The Y Balance Test measures the distance a subject can reach in three directions, anterior, posteromedial and posterolateral without moving a support foot or touching the reach foot to the floor. The Y Balance Test is scored based on the composite reach distance normalized by the subject's leg length.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Side Hop Test
The Side Hop Test measures the how long in seconds it takes for a subject can hop on one foot across two lines spaced 30 cm apart.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Edgren Side Step Test
The Edgren Side Step Test measures the distance in meters a subject sidestep across in 10 seconds traversing 5 lines 1 meter apart before reversing direction.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the T-Test
The T-Test measures the time it takes for a subject to traverse a 40m course in the shape of a "T" consisting of 10m each of forward motion, right side shuffle, left side-shuffle, and backwards motion.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in Electromyography (EMG)
EMG will be collected during walking to examine muscle activation timings and magnitudes.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Plantar Pressures
Plantar Pressures will be collected during walking to examine pressure distribution and progression of the center of pressure during stance phase.
Measured: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Ankle Reinjury Status
Timing of any ankle reinjuries during the follow-up period period will be recorded.
Measured: Over an 18 month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start23 Nov 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Instability; Ankle (Ligaments) (Old Injury)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be implemented using multi-site, parallel randomized clinical trial. Individuals will be randomly allocated between a control and experimental arm, stratified between lateral ankle sprains and chronic ankle instability.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Naval Medical Center, San Diego, Fort Sam Houston, Naval Hospital Camp Pendleton, Naval Health Research Center, VA Puget Sound Health Care System
- Responsible party
- Sponsor
- Investigators
- Pinata Sessoms, PhD, Principal investigator, Naval Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999904
- Sponsor's protocol ID
- 937017
- Other IDs
- W81XWH-20-2-0056
- Acronym
- ROCKY REHAB
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified primary outcome data will be published. Additional outcome data may also be included.
Publications
Russell Esposito E, Farrokhi S, Shuman BR, Sessoms PH, Szymanek E, Hoppes CW, Bechard L, King D, Fraser JJ. Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 22;11(6):e38442. doi: 10.2196/38442.
PubMed 35731551
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
- ClinicalTrials.gov ID
- NCT04999904
- Acronym / sponsor ID
- ROCKY REHAB / 937017
- Keywords
- Acute Ankle Sprain, Chronic Ankle Instability, Proprioceptive Training, Uneven Treadmill, Reinjury, Rehabilitation, Service Members
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- United States Naval Medical Center, San Diego, Fort Sam Houston, Naval Hospital Camp Pendleton, Naval Health Research Center, VA Puget Sound Health Care System
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Aug 2021 (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 ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability.
Detailed description
Lower limb sprains and strains are three-times more prevalent than any other acute injury in the Armed Forces, with lateral ankle sprains being the most common injury sustained during active-duty. Many individuals who experience an ankle sprain will go on to develop chronic ankle instability. Training and rehabilitation programs that incorporate proprioceptive training are particularly effective at improving outcomes and reducing re-injury rate. However, current programs do not help individuals "train to the tasks" that will be encountered once those individuals leave physical therapy. The proposed intervention evaluates the use of a rocky, uneven terrain treadmill that specifically targets aspects of the real-world environment for restoring and improving short-term function and performance and reducing the long-term risk of re-injury. This trial will randomly allocate 312 individuals with ankle sprains and chronic ankle instability to standard of care physical therapy or the standard of care supplemented with the uneven treadmill intervention. Patient reported outcome, performance measures, and biomechanical measures of muscle activations and plantar pressures will be evaluated. Patient reported outcomes and reinjury rates will be tracked for 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be implemented using multi-site, parallel randomized clinical trial. Individuals will be randomly allocated between a control and experimental arm, stratified between lateral ankle sprains and chronic ankle instability.
| Arm | Type | Receives |
|---|---|---|
| Uneven Treadmill Arm | Experimental | Other: Uneven Treadmill InterventionUneven Treadmill Intervention with up to twelve sessions over approximately six weeks and Standard of Care Physical Therapy with an 18 month follow-up period |
| Control Arm | Active comparator | Other: Standard of Care Physical TherapyStandard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Aged 18-49.
- Score < 24 on the Cumberland Ankle Instability Tool.
- Foot and Ankle Ability Measure Activities of Daily Living score ≤ 90 and Sports score ≤ 80 indicating substantial ankle-foot impairment and activity limitation.
- Able to attend treatment sessions for approximately a 6-week period.
- Passed most recent physical fitness test (Active duty only).
Key exclusion criteria (9 listed)
- Unable to walk at the point of study enrollment.
- Non-removable casting.
- History of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves).
- History of fracture in either limb of the lower extremity requiring realignment.
- Acute injury to musculoskeletal structures of other joints of the lower extremity within the previous three months, which impacted joint integrity and function resulting in at least one interrupted day of physical activity.
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 |
|---|---|---|
| Uneven Treadmill InterventionProgressive proprioceptive training on the uneven treadmill with up to twelve training sessions. Subjects will be advanced through activities with progression pragmatically assessed by the physical therapists for the benefit and tolerance of the individual subject. Activities may include: slow walking, fast walking, inclined/declined walking, head turning, vision obstruction, dual task walking, fatigued walking, load carriage. Standard of care physical therapy is still provided. | Other | Uneven Treadmill Arm |
| Standard of Care Physical TherapyStandard of Care Physical Therapy | Other | Control Arm |
Primary outcome
Change in the Cumberland Ankle Instability Tool
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
The Cumberland Ankle Instability Tool is a 9-item questionnaire, 30 points max score, with higher scores indicating better function. The Cumberland Ankle Instability Tool evaluates the severity of ankle instability during sport and activities of daily living, as well as pain.
Change in the Foot and Ankle Ability Measure, Activities of Daily Living Subscale
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
The Foot and Ankle Ability Measure: Activities of Daily Living subscale is a 21-item questionnaire with 84 points max, with higher scores indicating better function. The Activities of Daily Living Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during activities of daily living.
Change in the Foot and Ankle Ability Measure, Sports Subscale
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
The Foot and Ankle Ability Measure: Sports subscale is a 8-item questionnaire with 32 points max, with higher scores indicating better function. The Sports Subscale is used to assess activity limitations and restrictions for individuals with foot and ankle disorders, including ankle sprains, during recreational/sport activities.
11 secondary outcomes
Change in the Lower Extremity Functional Scale
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Tampa Scale of Kinesiophobia
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Numeric Pain Rating Scale
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Godin Leisure-Time Physical Activity Questionnaire
Time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.
Change in the Y Balance Test
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Side Hop Test
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Edgren Side Step Test
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the T-Test
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in Electromyography (EMG)
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Change in the Plantar Pressures
Time frame: Baseline assessment (0 weeks) and discharge assessment (6 weeks).
Ankle Reinjury Status
Time frame: Over an 18 month follow-up period.
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 18 Jul 2025.
- Derived from this study: PubMed 35731551Russell Esposito E, Farrokhi S, Shuman BR, Sessoms PH, Szymanek E, Hoppes CW, Bechard L, King D, Fraser JJ. Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 22;11(6):e38442. doi: 10.2196/38442.
- Individual participant dataSharing planned: Yes. De-identified primary outcome data will be published. Additional outcome data may also be included.
Related trials for Instability; Ankle (Ligaments) (Old Injury)
Not yet recruiting
EQUISOCK: New Antiequine
Ankle (Ligaments); Instability (Old Injury), Ankle Equinus
Not yet recruiting
Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy
Ankle Sprain, Ankle (Ligaments); Instability (Old Injury)
RecruitingObservational study
French Ankle Ligament Surgery Cohort Study
Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture
Recruiting
Bipedal vs. Unipedal Exercises in Chronic Ankle Instability
Instability; Ankle (Ligaments) (Old Injury)
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.
Pinata Sessoms, PhD principal investigator
Naval Health Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uneven Treadmill Intervention in people with Instability; Ankle (Ligaments) (Old Injury) and Sprain of Ankle, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
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 13 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Pinata Sessoms, PhD (619-553-7760, Pinata.h.sessoms.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Cumberland Ankle Instability Tool (time frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999904, which also lists 1 linked publication.
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 18 Jul 2025.