Femoral FractureRIFLENCT05274022
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
A study testing Speed Walking Intervention in people with Femoral Fracture and Tibial Fractures, run by Brian W. Noehren at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoral Fracture, Tibial Fractures
- What is being tested?
- Speed Walking Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2022to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Ability to read and speak English
- Acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation with an intramedullary rod
- Age 18-50 years of age
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
- Not employed at the time of the accident at least 20 hours per week.
- Spinal cord injury
- History of schizophrenia, dementia or neurologic disorder with peripheral dysfunction
Show all 12Show fewer
- Non ambulatory or limited ability to walk without an assistive device prior to the fracture
- Multiple trauma that prevents early weight bearing
- Current Pregnancy
- Unable to participate in or complete in-person follow-up visits or therapy sessions
- In outpatient Physical Therapy at the start of the intervention
- Use of an assistive device to walk for community ambulation at the 10-12 weeks post hospital discharge time point
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40506
Vanderbilt University
Nashville, Tennessee, 37203
About this study
The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.
Read the detailed description
In HIIT an individual gives short bursts of high effort followed by a longer recovery period.
Increasingly, HIIT style training programs have been used in other clinical populations (heart conditions, kidney failure, severely obese) to yield improved health outcomes and have been shown to be safe and effective. However, this work has not been extended to the orthopedic trauma population. Initiating a treadmill HIIT program during recovery from a lower extremity fracture may prove pivotal to restoring functional abilities, improving strength, and optimizing patient outcomes.
As a starting point to investigate the speed HIIT walking program following an orthopedic trauma, the investigators will focus on femoral and tibial shaft fractures requiring surgical fixation. Subjects will be recruited at a follow-up visit and therefore will not have impaired consent capacity issues at that juncture based on their fracture-related injuries. Even though early postoperative weight bearing has been shown to be safe, there continues to be considerable divergence in recovery after these fractures. For instance, return to work rates for individuals with physical jobs has been reported to be as low as 14% within the first year, resulting in significant stress and financial challenges for the individual. Clearly, improved post-operative rehabilitation strategies are needed for this population.
Aim 1: Assess the feasibility and adherence of the speed HIIT walk program within subjects with a lower extremity fracture.
Primary Hypothesis: 70% of subjects approached about the study will consent and that 80% of subjects will complete the study.
Secondary hypothesis: 80% of subjects will complete all of the treatment sessions and find the treatment (both intervention and standard of care physical therapy) acceptable.
Aim 2: Determine the preliminary effects of the speed HIIT program as compared to the standard of care on patient reported outcomes, functional outcomes and return to work rates, in a pilot randomized control trial.
Primary Hypotheses: Participants in the speed HIIT intervention group will have a significantly higher PROMIS physical function scale as compared to standard of care group at a 6 month follow up.
Secondary hypotheses: Participants in the Speed HIIT intervention group will have higher return to work rates, usual and fastest gait speed, timed step-down test, and 6-minute walk test than the standard of care group at a 6 month follow up.
Tertiary hypothesis: The participants in the speed HIIT program will maintain higher physical function and return to work rates at a 12 month follow up as compared to the standard of care group
Aim 3: Quantify the differences in ground reaction forces, function, psychosocial responses, and patient reported outcomes that occur at the completion of the speed HIIT walk program as compared to the group receiving standard of care physical therapy.
Primary Hypotheses: Participants in the speed HIIT program will be significantly more symmetric in their peak ground reaction force metrics (impulse, loading rates, time, peak values), and have greater self reported physical function, functional outcomes and patient reported outcomes as compared to the standard of care group at the completion of the intervention (19 weeks post hospital discharge).
Secondary hypotheses: Participants completing the speed HIIT program will have greater pain self-efficacy and less fear of movement as compared to the standard of care at the completion of the intervention (19 weeks post hospital discharge) that is maintained at a 6 and 12 month follow up.
Tertiary hypothesis: The participants in the speed HIIT program will maintain higher symmetry in their peak ground reaction force metrics (impulse, loading rates, time, peak values) as compared to the standard of care group at a 6 month follow up.
- Conditions
- Femoral Fracture, Tibial Fractures
- Being tested
- Standard of Care Physical Therapy Program, Speed Walking Intervention
- Keywords
- Surgical fixation, High intensity interval training
- Medical subject headings
- Femoral Fractures, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Physical Therapy ProgramOther
Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. As part of the study, all patients will receive the same exercise program. Exercises will include lower extremity strengthening, balance, and mobility exercises with the use of modalities as needed
Speed Walking InterventionOther
The 4-6 week program will consist of a warm up of active stretching. Following the warm up, subjects will perform a 2 minute warm up followed by 1 minute of walking at their fastest comfortable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing for 4cycles and then a 2 minute cool down. The program will be performed 12 visits over 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Physical Therapy Program | Placebo comparator | Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Receives: Other: Standard of Care Physical Therapy Program |
| Standard of Care Physical Therapy Program with Speed Walking Intervention | Experimental | Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Additionally, subjects will complete the speed walking intervention. Participants will perform at 2 minute warm up followed by 1 minute of walking at their fastest tolerable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing. The subjects will perform 4 cycles of this followed by a 2 minute cool down at the end. Receives: Other: Standard of Care Physical Therapy Program; Other: Speed Walking Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical function
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Measured: Up to 12 weeks
Self-reported physical function
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Measured: Up to 19 weeks
Self-reported physical function
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Measured: 6 months
Self-reported physical function
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Measured: 12 months
Secondary outcomes (32)
60-second step down test
Standing on an 4-inch box, participants will step down until the heel gently touches a scale placed on the ground and then return to full knee extension. As many repetitions as possible in 60 seconds will be recorded. Repetitions with over 10% of the body weight registered on the scale will not be counted toward the total number of repetitions completed. The test has previously been shown to have a high interrater reliability of 0.94 and was associated with a change in knee mechanics following an orthopedic surgery.
Interpretation: More successful repetitions indicate greater neuromuscular control and muscle strength in the lower extremity.
Measured: Up to 12 weeks
60-second step down test
Standing on an 4-inch box, participants will step down until the heel gently touches a scale placed on the ground and then return to full knee extension. As many repetitions as possible in 60 seconds will be recorded. Repetitions with over 10% of the body weight registered on the scale will not be counted toward the total number of repetitions completed. The test has previously been shown to have a high interrater reliability of 0.94 and was associated with a change in knee mechanics following an orthopedic surgery.
Interpretation: More successful repetitions indicate greater neuromuscular control and muscle strength in the lower extremity.
Measured: Up to 19 weeks
60-second step down test
Standing on an 4-inch box, participants will step down until the heel gently touches a scale placed on the ground and then return to full knee extension. As many repetitions as possible in 60 seconds will be recorded. Repetitions with over 10% of the body weight registered on the scale will not be counted toward the total number of repetitions completed. The test has previously been shown to have a high interrater reliability of 0.94 and was associated with a change in knee mechanics following an orthopedic surgery.
Interpretation: More successful repetitions indicate greater neuromuscular control and muscle strength in the lower extremity.
Measured: 6 months.
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Measured: Up to 12 weeks
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Measured: Up to 19 weeks
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Measured: 6 months
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Measured: Up to 12 weeks
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Measured: Up to 19 weeks
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Measured: 6 months
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
Measured: Up to 12 weeks
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
Measured: Up to 19 weeks
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
Measured: 6 months
Pain Assessment
Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
Measured: Up to 12 weeks
Pain Assessment
Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
Measured: Up to 19 weeks
Pain Assessment
Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
Measured: 6 months
Pain Assessment
Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
Measured: 12 months
Pain self-efficacy scale (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questions and will be used measure an individual's beliefs about their ability to participate in social activity and accomplish their goals despite the presence of pain. PSEQ has demonstrated excellent internal consistency, test-retest reliability, and construct validity.
Interpretation: Greater self-efficacy (higher survey score) is related to reductions in disability, pain intensity, fear of movement and pain, and affective distress in patients with chronic pain.
Scale: 0-6 0 (not at all confident)
1 2 3 4 5 6 (completely confident)
Measured: Up to 12 weeks
Pain self-efficacy scale (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questions and will be used measure an individual's beliefs about their ability to participate in social activity and accomplish their goals despite the presence of pain. PSEQ has demonstrated excellent internal consistency, test-retest reliability, and construct validity.
Interpretation: Greater self-efficacy (higher survey score) is related to reductions in disability, pain intensity, fear of movement and pain, and affective distress in patients with chronic pain.
Scale: 0-6 0 (not at all confident)
1 2 3 4 5 6 (completely confident)
Measured: Up to 19 weeks
Pain self-efficacy scale (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questions and will be used measure an individual's beliefs about their ability to participate in social activity and accomplish their goals despite the presence of pain. PSEQ has demonstrated excellent internal consistency, test-retest reliability, and construct validity.
Interpretation: Greater self-efficacy (higher survey score) is related to reductions in disability, pain intensity, fear of movement and pain, and affective distress in patients with chronic pain.
Scale: 0-6 0 (not at all confident)
1 2 3 4 5 6 (completely confident)
Measured: 6 months
Pain self-efficacy scale (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questions and will be used measure an individual's beliefs about their ability to participate in social activity and accomplish their goals despite the presence of pain. PSEQ has demonstrated excellent internal consistency, test-retest reliability, and construct validity.
Interpretation: Greater self-efficacy (higher survey score) is related to reductions in disability, pain intensity, fear of movement and pain, and affective distress in patients with chronic pain.
Scale: 0-6 0 (not at all confident)
1 2 3 4 5 6 (completely confident)
Measured: 12 months
Tampa scale of kinesiophobia (TSK)
The TSK is a 17-item questionnaire and will be administered to record fear of movement (kinesiophobia).
Interpretation: Higher survey scores indicates greater kinesiophobia in people with chronic pain.
Scale: (0-3) 0, Strongly disagree
- Disagree
- Agree
- Strongly agree
Measured: Up to 12 weeks
Tampa scale of kinesiophobia (TSK)
The TSK is a 17-item questionnaire and will be administered to record fear of movement (kinesiophobia).
Interpretation: Higher survey scores indicates greater kinesiophobia in people with chronic pain.
Scale: (0-3) 0, Strongly disagree
- Disagree
- Agree
- Strongly agree
Measured: Up to 19 weeks
Tampa scale of kinesiophobia (TSK)
The TSK is a 17-item questionnaire and will be administered to record fear of movement (kinesiophobia).
Interpretation: Higher survey scores indicates greater kinesiophobia in people with chronic pain.
Scale: (0-3) 0, Strongly disagree
- Disagree
- Agree
- Strongly agree
Measured: 6 months
Tampa scale of kinesiophobia (TSK)
The TSK is a 17-item questionnaire and will be administered to record fear of movement (kinesiophobia).
Interpretation: Higher survey scores indicates greater kinesiophobia in people with chronic pain.
Scale: (0-3) 0, Strongly disagree
- Disagree
- Agree
- Strongly agree
Measured: 12 months
Return to Work Status: Hours Worked
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Measured: Up to 12 weeks
Return to Work Status: Hours Worked
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Measured: Up to 19 weeks
Return to Work Status: Hours Worked
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Measured: 6 months
Return to Work Status: Hours Worked
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Measured: 12 months
Return to Work Status: Ability to Work
Work Productivity and Activity Impairment Questionnaire (WPAI) part 2 includes 2 questions with a 10 point scale where a lower number indicates a greater ability to work with no health problems.
Measured: Up to 12 weeks
Return to Work Status: Ability to Work
Work Productivity and Activity Impairment Questionnaire (WPAI) part 2 includes 2 questions with a 10 point scale where a lower number indicates a greater ability to work with no health problems.
Measured: Up to 19 weeks
Return to Work Status: Ability to Work
Work Productivity and Activity Impairment Questionnaire (WPAI) part 2 includes 2 questions with a 10 point scale where a lower number indicates a greater ability to work with no health problems.
Measured: 6 months
Return to Work Status: Ability to Work
Work Productivity and Activity Impairment Questionnaire (WPAI) part 2 includes 2 questions with a 10 point scale where a lower number indicates a greater ability to work with no health problems.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start3 Mar 2022
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FractureStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian W. Noehren
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor-investigator, Brian W. Noehren, University of Kentucky
- Investigators
- Brian Noehren, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274022
- Sponsor's protocol ID
- 65286
- Other IDs
- CDMRP-CDMRP-OR200133-A
- Acronym
- RIFLE
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
- ClinicalTrials.gov ID
- NCT05274022
- Acronym / sponsor ID
- RIFLE / 65286
- Conditions
- Femoral Fracture, Tibial Fractures
- Keywords
- Surgical fixation, High intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brian W. NoehrenUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 10 Mar 2022 (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 purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.
Detailed description
In HIIT an individual gives short bursts of high effort followed by a longer recovery period.
Increasingly, HIIT style training programs have been used in other clinical populations (heart conditions, kidney failure, severely obese) to yield improved health outcomes and have been shown to be safe and effective. However, this work has not been extended to the orthopedic trauma population. Initiating a treadmill HIIT program during recovery from a lower extremity fracture may prove pivotal to restoring functional abilities, improving strength, and optimizing patient outcomes.
As a starting point to investigate the speed HIIT walking program following an orthopedic trauma, the investigators will focus on femoral and tibial shaft fractures requiring surgical fixation. Subjects will be recruited at a follow-up visit and therefore will not have impaired consent capacity issues at that juncture based on their fracture-related injuries. Even though early postoperative weight bearing has been shown to be safe, there continues to be considerable divergence in recovery after these fractures. For instance, return to work rates for individuals with physical jobs has been reported to be as low as 14% within the first year, resulting in significant stress and financial challenges for the individual. Clearly, improved post-operative rehabilitation strategies are needed for this population.
Aim 1: Assess the feasibility and adherence of the speed HIIT walk program within subjects with a lower extremity fracture.
Primary Hypothesis: 70% of subjects approached about the study will consent and that 80% of subjects will complete the study.
Secondary hypothesis: 80% of subjects will complete all of the treatment sessions and find the treatment (both intervention and standard of care physical therapy) acceptable.
Aim 2: Determine the preliminary effects of the speed HIIT program as compared to the standard of care on patient reported outcomes, functional outcomes and return to work rates, in a pilot randomized control trial.
Primary Hypotheses: Participants in the speed HIIT intervention group will have a significantly higher PROMIS physical function scale as compared to standard of care group at a 6 month follow up.
Secondary hypotheses: Participants in the Speed HIIT intervention group will have higher return to work rates, usual and fastest gait speed, timed step-down test, and 6-minute walk test than the standard of care group at a 6 month follow up.
Tertiary hypothesis: The participants in the speed HIIT program will maintain higher physical function and return to work rates at a 12 month follow up as compared to the standard of care group
Aim 3: Quantify the differences in ground reaction forces, function, psychosocial responses, and patient reported outcomes that occur at the completion of the speed HIIT walk program as compared to the group receiving standard of care physical therapy.
Primary Hypotheses: Participants in the speed HIIT program will be significantly more symmetric in their peak ground reaction force metrics (impulse, loading rates, time, peak values), and have greater self reported physical function, functional outcomes and patient reported outcomes as compared to the standard of care group at the completion of the intervention (19 weeks post hospital discharge).
Secondary hypotheses: Participants completing the speed HIIT program will have greater pain self-efficacy and less fear of movement as compared to the standard of care at the completion of the intervention (19 weeks post hospital discharge) that is maintained at a 6 and 12 month follow up.
Tertiary hypothesis: The participants in the speed HIIT program will maintain higher symmetry in their peak ground reaction force metrics (impulse, loading rates, time, peak values) as compared to the standard of care group at a 6 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Physical Therapy Program | Placebo comparator | Other: Standard of Care Physical Therapy ProgramStandard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. |
| Standard of Care Physical Therapy Program with Speed Walking Intervention | Experimental | Other: Standard of Care Physical Therapy Program, Other: Speed Walking InterventionStandard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Additionally, subjects will complete the speed walking intervention. Participants will perform at 2 minute warm up followed by 1 minute of walking at their fastest tolerable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing. The subjects will perform 4 cycles of this followed by a 2 minute cool down at the end. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ability to read and speak English
- Acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation with an intramedullary rod
- Age 18-50 years of age
Key exclusion criteria (12 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
- Not employed at the time of the accident at least 20 hours per week.
- Spinal cord injury
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 |
|---|---|---|
| Standard of Care Physical Therapy ProgramStandard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. As part of the study, all patients will receive the same exercise program. Exercises will include lower extremity strengthening, balance, and mobility exercises with the use of modalities as needed | Other | Standard of Care Physical Therapy Program, Standard of Care Physical Therapy Program with Speed Walking Intervention |
| Speed Walking InterventionThe 4-6 week program will consist of a warm up of active stretching. Following the warm up, subjects will perform a 2 minute warm up followed by 1 minute of walking at their fastest comfortable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing for 4cycles and then a 2 minute cool down. The program will be performed 12 visits over 4-6 weeks. | Other | Standard of Care Physical Therapy Program with Speed Walking Intervention |
Primary outcome
Self-reported physical function
Time frame: Up to 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Self-reported physical function
Time frame: Up to 19 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Self-reported physical function
Time frame: 6 months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
Self-reported physical function
Time frame: 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.
32 secondary outcomes
60-second step down test
Time frame: Up to 12 weeks
60-second step down test
Time frame: Up to 19 weeks
60-second step down test
Time frame: 6 months.
Usual Gait Speed
Time frame: Up to 12 weeks
Usual Gait Speed
Time frame: Up to 19 weeks
Usual Gait Speed
Time frame: 6 months
Fastest Walking Speed
Time frame: Up to 12 weeks
Fastest Walking Speed
Time frame: Up to 19 weeks
Fastest Walking Speed
Time frame: 6 months
Six-minute walk Test:
Time frame: Up to 12 weeks
Six-minute walk Test:
Time frame: Up to 19 weeks
Six-minute walk Test:
Time frame: 6 months
Pain Assessment
Time frame: Up to 12 weeks
Pain Assessment
Time frame: Up to 19 weeks
Pain Assessment
Time frame: 6 months
Pain Assessment
Time frame: 12 months
Pain self-efficacy scale (PSEQ)
Time frame: Up to 12 weeks
Pain self-efficacy scale (PSEQ)
Time frame: Up to 19 weeks
Pain self-efficacy scale (PSEQ)
Time frame: 6 months
Pain self-efficacy scale (PSEQ)
Time frame: 12 months
Tampa scale of kinesiophobia (TSK)
Time frame: Up to 12 weeks
Tampa scale of kinesiophobia (TSK)
Time frame: Up to 19 weeks
Tampa scale of kinesiophobia (TSK)
Time frame: 6 months
Tampa scale of kinesiophobia (TSK)
Time frame: 12 months
Return to Work Status: Hours Worked
Time frame: Up to 12 weeks
Return to Work Status: Hours Worked
Time frame: Up to 19 weeks
Return to Work Status: Hours Worked
Time frame: 6 months
Return to Work Status: Hours Worked
Time frame: 12 months
Return to Work Status: Ability to Work
Time frame: Up to 12 weeks
Return to Work Status: Ability to Work
Time frame: Up to 19 weeks
Return to Work Status: Ability to Work
Time frame: 6 months
Return to Work Status: Ability to Work
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Brian Noehren, Ph.D. principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed Walking Intervention in people with Femoral Fracture and Tibial Fractures, run by Brian W. Noehren 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 8 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical function (time frame: Up to 12 weeks). The study lists 4 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 8 Jan 2026.