Ankle FracturesAMPNCT07173088
Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
A study testing Ankle Muscle Power (AMP) program in people with Ankle Fractures, run by Brian W. Noehren at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Ankle Muscle Power (AMP) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to Mar 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years old
- Acute orthopedic injury to the ankle requiring surgical fixation
- Must have stable address and phone number to schedule follow up contact visits
- English speaking
- BMI ≤ 35 kg/m2
Who cannot join
- History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started before the fracture
- Moderate or severe traumatic brain injury
- Initial treatment requiring amputation
- Spinal cord injury
- Unable to speak or read English
- History of schizophrenia, dementia, neurologic disorder with peripheral dysfunction, or other psychotic disorder based upon medical record or patient self-report
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- Any chronic conditions that would limit their ability to participate in an intervention
- Multiple trauma that prevents engaging in intervention
- Pregnant
- Unable to participate in or complete in-person follow up visits or therapy sessions
- In Physical Therapy at the start of the intervention.
- Use of an assistive device to walk for community ambulation
- Prior lower extremity fracture within the past 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Research Associate Senior, 859-323-5438, delong2@uky.edu
About this study
The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are:
- Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power. Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention.
- Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention.
- Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life.
Read more
Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM)
Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.
- Conditions
- Ankle Fractures
- Being tested
- Ankle Muscle Power (AMP) program, Standard of Care
- Keywords
- Physical Therapy, Rehabilitation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Muscle Power (AMP) programOther
Also called Physical Therapy
The AMP program targets various aspects of muscle power development through a program that takes the participant through 3 different stages of training over the course of their rehabilitation. This portion of the program is in addition to receiving standard rehabilitation exercises as well.
Standard of CareBehavioural
Standard rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Ankle Muscle Power (AMP) program + standard of care | Experimental | Participants will receive standard of care rehabilitation as needed and directed by the treating physical therapist. Participants will have additional exercises included to facilitate the development of power that will progress as participants move through the rehabilitation program.
The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and will have visits for up to 12 weeks with an average of 3 visits per week. Receives: Other: Ankle Muscle Power (AMP) program; Behavioral: Standard of Care |
| Standard of care only | Active comparator | Standard of care rehabilitation includes range of motion, foundational strength exercises, and other modalities (i.e., icing and or low grade NMES) as needed and directed by the treating physical therapist.
The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and rehabilitation will take place for up to 12 weeks with visits occurring 3 times per week on average. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Adhering to the Intervention
Adherence refers to the commitment of a participant to participate in the rehab. Adherence will be measured by calculating the number of rehab sessions attended divided by the number of rehab sessions possible.
Measured: From baseline assessment to completion of the 10 week intervention.
Percentage of Treatment That is Able to be Delivered (Fidelity)
Fidelity refers to the ability to perform the protocol as intended and that the participants receive the intended treatment as designed. It will be calculated as the number of deviations from protocol divided by the number of treatment sessions.
Measured: From baseline assessment to completion of the 10 week intervention.
Percentage of Participants Completing the Intervention (Retention)
This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.
Measured: From baseline assessment to completion of the 10 week intervention.
Percentage of Participants Who Find the Program Acceptable/Satisfactory
A participant satisfaction survey will be utilized to evaluate each rehabilitation protocol, care given, and rehab facility procedures. Scores will range from 1 to 5 with 1 indicating poor performance of the facility and care received versus 5 indicating excellent performance of the facility and care received.
Measured: From baseline assessment to completion of the 10 week intervention.
Change in Isometric Ankle Plantar Flexor Muscle Power
Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up
Measured: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Change in Ankle Rate of Torque Development (Ankle RTD)
Will be assessed isometrically on a dynamometer as the change between baseline and post-intervention follow-up. Ankle RTD is calculated as the initial slope of the generated force curve, measured in Newton meters per second.
Measured: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Change in Ankle Joint Power During Gait
Ankle joint power measured with 3D motion capture during walking
Measured: Baseline and post intervention (10-12 weeks following baseline)
Change in Ankle Joint Power During Stairs (step up and down)
Ankle joint power measured with 3D motion capture while climbing stairs
Measured: Baseline and post intervention (10-12 weeks following baseline)
Secondary outcomes (5)
Change in Usual Gait Speed
Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded.
Measured: Baseline and post intervention (10-12 weeks following baseline)
Change in Fastest Gait Speed
Participants will walk at their fastest comfortable speed with the time to complete 5 meters recored.
Measured: Baseline and following completion of the intervention (10-12 weeks post baseline visit)
Change in 11 Stair Climb Test Score
The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps (11). Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance.
Measured: Baseline visit and post intervention visit (10-12 weeks post baseline)
Change in Ankle fracture outcome rehabilitation measure (A-FORM)
The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is a patient-reported outcome measure designed to assess recovery after an ankle fracture. It focuses on physical, social, and psychological aspects of recovery. A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes.
Measured: Baseline and post intervention (10-12 weeks following baseline)
Change in PROMIS Physical Function Computer Adaptive Test
The PROMIS Physical Function computer adaptive test will be administered to each subject. Scale 0-100, where higher numbers indicate better physical functioning. A score of 50 is consistent with the mean score of the U.S. general population.
Measured: Baseline assessment and post intervention visit (10-12 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start13 Nov 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian W. Noehren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian W. Noehren, University of Kentucky
- Investigators
- Principal Investigator, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173088
- Sponsor's protocol ID
- 103812
- Other IDs
- HT9425-25-1-0625
- Acronym
- AMP
- Status last verified
- Nov 2025
- First submitted
- 2 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dissemination plan emphasizes transparency of the study, and as a study team, the investigators are committed to sharing de-identified data for external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
- ClinicalTrials.gov ID
- NCT07173088
- Acronym / sponsor ID
- AMP / 103812
- Conditions
- Ankle Fractures
- Keywords
- Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brian W. NoehrenUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Sep 2025 (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 clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are:
- Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power. Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention.
- Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention.
- Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life.
Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM)
Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle Muscle Power (AMP) program + standard of care | Experimental | Other: Ankle Muscle Power (AMP) program, Behavioral: Standard of CareParticipants will receive standard of care rehabilitation as needed and directed by the treating physical therapist. Participants will have additional exercises included to facilitate the development of power that will progress as participants move through the rehabilitation program. The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and will have visits for up to 12 weeks with an average of 3 visits per week. |
| Standard of care only | Active comparator | Behavioral: Standard of CareStandard of care rehabilitation includes range of motion, foundational strength exercises, and other modalities (i.e., icing and or low grade NMES) as needed and directed by the treating physical therapist. The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and rehabilitation will take place for up to 12 weeks with visits occurring 3 times per week on average. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 years old
- Acute orthopedic injury to the ankle requiring surgical fixation
- Must have stable address and phone number to schedule follow up contact visits
- English speaking
- BMI ≤ 35 kg/m2
Key exclusion criteria (13 listed)
- History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started before the fracture
- Moderate or severe traumatic brain injury
- Initial treatment requiring amputation
- Spinal cord injury
- Unable to speak or read English
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 |
|---|---|---|
| Ankle Muscle Power (AMP) programAlso: Physical TherapyThe AMP program targets various aspects of muscle power development through a program that takes the participant through 3 different stages of training over the course of their rehabilitation. This portion of the program is in addition to receiving standard rehabilitation exercises as well. | Other | Ankle Muscle Power (AMP) program + standard of care |
| Standard of CareStandard rehabilitation program | Behavioural | Ankle Muscle Power (AMP) program + standard of care, Standard of care only |
Primary outcome
Percentage of Participants Adhering to the Intervention
Time frame: From baseline assessment to completion of the 10 week intervention.
Adherence refers to the commitment of a participant to participate in the rehab. Adherence will be measured by calculating the number of rehab sessions attended divided by the number of rehab sessions possible.
Percentage of Treatment That is Able to be Delivered (Fidelity)
Time frame: From baseline assessment to completion of the 10 week intervention.
Fidelity refers to the ability to perform the protocol as intended and that the participants receive the intended treatment as designed. It will be calculated as the number of deviations from protocol divided by the number of treatment sessions.
Percentage of Participants Completing the Intervention (Retention)
Time frame: From baseline assessment to completion of the 10 week intervention.
This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.
Percentage of Participants Who Find the Program Acceptable/Satisfactory
Time frame: From baseline assessment to completion of the 10 week intervention.
A participant satisfaction survey will be utilized to evaluate each rehabilitation protocol, care given, and rehab facility procedures. Scores will range from 1 to 5 with 1 indicating poor performance of the facility and care received versus 5 indicating excellent performance of the facility and care received.
Change in Isometric Ankle Plantar Flexor Muscle Power
Time frame: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up
Change in Ankle Rate of Torque Development (Ankle RTD)
Time frame: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Will be assessed isometrically on a dynamometer as the change between baseline and post-intervention follow-up. Ankle RTD is calculated as the initial slope of the generated force curve, measured in Newton meters per second.
Change in Ankle Joint Power During Gait
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture during walking
Change in Ankle Joint Power During Stairs (step up and down)
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture while climbing stairs
5 secondary outcomes
Change in Usual Gait Speed
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Change in Fastest Gait Speed
Time frame: Baseline and following completion of the intervention (10-12 weeks post baseline visit)
Change in 11 Stair Climb Test Score
Time frame: Baseline visit and post intervention visit (10-12 weeks post baseline)
Change in Ankle fracture outcome rehabilitation measure (A-FORM)
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Change in PROMIS Physical Function Computer Adaptive Test
Time frame: Baseline assessment and post intervention visit (10-12 weeks later)
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 2 Dec 2025.
- Individual participant dataSharing planned: Yes. The dissemination plan emphasizes transparency of the study, and as a study team, the investigators are committed to sharing de-identified data for external researchers.
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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.
Principal Investigator principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Muscle Power (AMP) program in people with Ankle Fractures, run by Brian W. Noehren at 1 site 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 5 inclusion and 13 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Research Associate Senior (859-323-5438, delong2@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Adhering to the Intervention (time frame: From baseline assessment to completion of the 10 week intervention.). The study lists 8 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 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.