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Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture (RIFLE)

Primary Purpose

Femoral Fracture, Tibial Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Physical Therapy Program
Speed Walking Intervention
Sponsored by
Brian W. Noehren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fracture focused on measuring Surgical fixation, High intensity interval training

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of KentuckyRecruiting
  • Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard of Care Physical Therapy Program

Standard of Care Physical Therapy Program with Speed Walking Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Usual Gait Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Fastest Walking Speed
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
Six-minute walk Test:
The participant will be provided with six minutes to walk as far as possible.
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.''
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.''
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.''
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.''
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)
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)
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)
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)
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 29, 2021
Last Updated
July 5, 2023
Sponsor
Brian W. Noehren
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT05274022
Brief Title
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
Acronym
RIFLE
Official Title
Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian W. Noehren
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture, Tibial Fractures
Keywords
Surgical fixation, High intensity interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Physical Therapy Program
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standard of Care Physical Therapy Program with Speed Walking Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care Physical Therapy Program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Speed Walking Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported physical function
Description
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.
Time Frame
Up to 12 weeks
Title
Self-reported physical function
Description
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.
Time Frame
Up to 19 weeks
Title
Self-reported physical function
Description
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.
Time Frame
6 months
Title
Self-reported physical function
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
60-second step down test
Description
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.
Time Frame
Up to 12 weeks
Title
60-second step down test
Description
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.
Time Frame
Up to 19 weeks
Title
60-second step down test
Description
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.
Time Frame
6 months.
Title
Usual Gait Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Time Frame
Up to 12 weeks
Title
Usual Gait Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Time Frame
Up to 19 weeks
Title
Usual Gait Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their usual walking speed.
Time Frame
6 months
Title
Fastest Walking Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Time Frame
Up to 12 weeks
Title
Fastest Walking Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Time Frame
Up to 19 weeks
Title
Fastest Walking Speed
Description
Participant usual gait speed as measured over 2 trials of walking along a 20 meter walkway at their fastest walking speed.
Time Frame
6 months
Title
Six-minute walk Test:
Description
The participant will be provided with six minutes to walk as far as possible.
Time Frame
Up to 12 weeks
Title
Six-minute walk Test:
Description
The participant will be provided with six minutes to walk as far as possible.
Time Frame
Up to 19 weeks
Title
Six-minute walk Test:
Description
The participant will be provided with six minutes to walk as far as possible.
Time Frame
6 months
Title
Pain Assessment
Description
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.''
Time Frame
Up to 12 weeks
Title
Pain Assessment
Description
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.''
Time Frame
Up to 19 weeks
Title
Pain Assessment
Description
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.''
Time Frame
6 months
Title
Pain Assessment
Description
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.''
Time Frame
12 months
Title
Pain self-efficacy scale (PSEQ)
Description
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)
Time Frame
Up to 12 weeks
Title
Pain self-efficacy scale (PSEQ)
Description
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)
Time Frame
Up to 19 weeks
Title
Pain self-efficacy scale (PSEQ)
Description
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)
Time Frame
6 months
Title
Pain self-efficacy scale (PSEQ)
Description
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)
Time Frame
12 months
Title
Tampa scale of kinesiophobia (TSK)
Description
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
Time Frame
Up to 12 weeks
Title
Tampa scale of kinesiophobia (TSK)
Description
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
Time Frame
Up to 19 weeks
Title
Tampa scale of kinesiophobia (TSK)
Description
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
Time Frame
6 months
Title
Tampa scale of kinesiophobia (TSK)
Description
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
Time Frame
12 months
Title
Return to Work Status: Hours Worked
Description
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Time Frame
Up to 12 weeks
Title
Return to Work Status: Hours Worked
Description
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Time Frame
Up to 19 weeks
Title
Return to Work Status: Hours Worked
Description
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Time Frame
6 months
Title
Return to Work Status: Hours Worked
Description
Work Productivity and Activity Impairment Questionnaire (WPAI) part 1 includes three questions about the number of hours worked in the last seven days.
Time Frame
12 months
Title
Return to Work Status: Ability to Work
Description
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.
Time Frame
Up to 12 weeks
Title
Return to Work Status: Ability to Work
Description
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.
Time Frame
Up to 19 weeks
Title
Return to Work Status: Ability to Work
Description
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.
Time Frame
6 months
Title
Return to Work Status: Ability to Work
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Loading of the lower extremity
Description
The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric.
Time Frame
Up to 12 weeks
Title
Loading of the lower extremity
Description
The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric.
Time Frame
Up to 19 weeks
Title
Loading of the lower extremity
Description
The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Noehren, Ph.D.
Phone
859-218-0581
Email
b.noehren@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Seth Polk, MS
Phone
7573341517
Email
seth.polk@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Noehren, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Priest, LPN
Phone
615-421-8336
Email
amanda.priest@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture

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