Musculoskeletal InjuryNCT04612478
Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
A study testing Self-Directed Exercise Program and Clinic-Based Physical in people with Musculoskeletal Injury, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness and value of clinic-based physical therapy (PT) and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Self-Directed Exercise Program and Clinic-Based Physical
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2018to 2 Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 with operative fractures of the femur and tibia (to include distal femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries (44A, B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up of care performed elsewhere (within 14 days of the injury).
- All patients must be English or Spanish competent and able to be followed at the sites for at least 12 months following injury.
Who cannot join
- Patients with Injury Severity Score (ISS)>18
- Bilateral lower-extremity injuries that preclude crutch ambulation
- Associated spine, pelvic, and/or acetabular fractures that otherwise alter weightbearing plan
- Type III B/C open fractures
- Glasgow Coma Scale <15 at time of discharge
- Major peripheral nerve injury
Show all 9Show fewer
- Planned admission to a skilled nursing facility or inpatient rehabilitation facility
- Pregnant women
- Patients diagnosed with a Traumatic Brain Injury (TBI) will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Greenville Health System
Greenville, South Carolina, 29605
About this study
The purpose of this study is to compare the effectiveness and value of clinic-based physical therapy (PT) and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.
Read the detailed description
There is little clinical debate that patients with multiple extremity injuries or injuries with associated complex soft tissue damage or nerve deficits benefit from supervised PT. Prior research from the LEAP Study examined the impact of PT on patients with high energy trauma injuries below the distal femur.1 While the surgeons and PTs differed in their assessment of perceived need for PT,2,3 evidence demonstrates the beneficial effect of PT for this patient population.4 Research on combat-related lower extremity limb salvage patients showed a significant benefit and a higher return-to-duty rate following intense and focused rehabilitation combined with an integrated orthotic.5-7 However, the majority of lower extremity fractures seen in the military and civilian sectors are not combat related or of the severity of the Lower Extremity Assessment Project (LEAP) limb salvage patients and, thus may not require intensive, clinic-based, supervised PT treatment. Patients with isolated major lower extremity fractures may benefit from a self-guided, home-based post-injury exercise program. Studies evaluating home exercise programs for elective orthopaedic reconstruction surgery for joint replacement and anterior cruciate ligament (ACL )reconstruction have reported equivalent outcomes compared to in-person, supervised PT.8-12 Because PT resources are critical, limited, and expensive in most civilian centers, identifying the patients who would most benefit from utilizing these resources could result in savings for both the patients and the health care systems, and lead to more efficient access to PT services by the population who needs them the most. In addition to health systems benefits, patients able to achieve positive outcomes through a home-based, self-directed exercise program would experience flexibility regarding when the exercises are performed.
The purpose of this study is to compare the effectiveness and value of clinic-based PT and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.
Hypothesis: The overall hypothesis is that return to work/major activities as well as clinical and functional outcomes and health-related quality of life for patients who receive clinic-based PT will be similar to patients receiving SDEP.
Specific Aim 1: To compare the effectiveness of SDEP, exercise instructions given by physician and clinic-based PT for improving return to work/major activities, clinical and functional/performance outcomes and health-related quality of life in patients following selected lower-extremity fractures.
Specific Aim 2: To determine which sub-groups of patients, based on patient and injury characteristics, are most likely to benefit from SDEP.
Specific Aim 3: To compare the cost-effectiveness of clinic-based PT and SDEP
.
- Conditions
- Musculoskeletal Injury
- Being tested
- Self-Directed Exercise Program, Clinic-Based Physical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Directed Exercise ProgramBehavioural
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program
Clinic-Based PhysicalBehavioural
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
| Study group | Role | What they receive |
|---|---|---|
| Clinic-Based Physical Therapy | Other | Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan. Receives: Behavioral: Clinic-Based Physical |
| Self-Directed Exercise Program | Other | The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program. The SDEP manual will provide detailed instructions on exercises, such as repetitions, frequency, and required equipment, which can be implemented in the home environment. The basis for the exercise regimen is derived from the American Academy of Orthopaedic Surgeons (AAOS) sample home based exercise program available in handout form. The program provides instructions on exercises, repetitions or duration, frequency, and required equipment which can be implemented in the home environment. Receives: Behavioral: Self-Directed Exercise Program |
| Observational | No intervention | Patients who are unwilling to be randomized will be enrolled in an observational arm of the study. They will be asked to complete all baseline and follow-up assessments, and participation in formal PT or SDEP will be documented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work/major activities
Measured through the rate of return to work/duty 12 months post discharge using the Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 12 months
Secondary outcomes (6)
Change in Quality of Life
The PROMIS-29 Profile v2.0 assesses depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. Raw scores range from 4-20, with higher scores indicating lower quality of life in that area, except for the sleep disturbance sub-section, where higher scores indicate better sleep.
Measured: baseline, 3, 6 and12 months
Kinesiophobia
As measured by Tampa Scale for Kinesiophobia (TSK). The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia
Measured: baseline, 3, 6 and12 months
Time to Radiographic Fracture Healing
Radiographs will be assessed for fracture healing.
Measured: 3, 6 & 12 months
Muscle Strength
Muscle strength will be measured using a dynamometer.
Measured: 12 months
Joint Range of Motion (ROM)
Joint range of motion will be measured using a goniomenter.
Measured: 12 months
Resilience
Resiliency will be measured using the Connor-Davidson Resilience Scale. Total Score of the resilience questions is 0 to 40, 10 subscales from 0 to 4 (summed up for total score), the higher the score the better the resilience
Measured: Baseline, 3, 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start14 Mar 2018
- Primary completion2 Nov 2022
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Seymour, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612478
- Sponsor's protocol ID
- IRB00082966
- Other IDs
- Pro00024283
- Status last verified
- Jan 2024
- First submitted
- 7 May 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
PubMed 12477942Castillo RC, MacKenzie EJ, Webb LX, Bosse MJ, Avery J; LEAP Study Group. Use and perceived need of physical therapy following severe lower-extremity trauma. Arch Phys Med Rehabil. 2005 Sep;86(9):1722-8. doi: 10.1016/j.apmr.2005.03.005.
PubMed 16181933Archer KR, Mackenzie EJ, Castillo RC, Bosse MJ; LEAP Study Group. Orthopedic surgeons and physical therapists differ in assessment of need for physical therapy after traumatic lower-extremity injury. Phys Ther. 2009 Dec;89(12):1337-49. doi: 10.2522/ptj.20080200. Epub 2009 Oct 29.
PubMed 19875460Castillo RC, MacKenzie EJ, Archer KR, Bosse MJ, Webb LX; LEAP Study Group. Evidence of beneficial effect of physical therapy after lower-extremity trauma. Arch Phys Med Rehabil. 2008 Oct;89(10):1873-9. doi: 10.1016/j.apmr.2008.01.032.
PubMed 18929015Blair JA, Patzkowski JC, Blanck RV, Owens JG, Hsu JR; Skeletal Trauma Research Consortium (STReC). Return to duty after integrated orthotic and rehabilitation initiative. J Orthop Trauma. 2014 Apr;28(4):e70-4. doi: 10.1097/BOT.0000000000000006.
PubMed 24121984Bedigrew KM, Patzkowski JC, Wilken JM, Owens JG, Blanck RV, Stinner DJ, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma? Clin Orthop Relat Res. 2014 Oct;472(10):3017-25. doi: 10.1007/s11999-014-3609-7.
PubMed 24744130Patzkowski JC, Owens JG, Blanck RV, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Deployment after limb salvage for high-energy lower-extremity trauma. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S112-5. doi: 10.1097/TA.0b013e3182606291.
PubMed 22847079Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
PubMed 26178888Fischer DA, Tewes DP, Boyd JL, Smith JP, Quick DC. Home based rehabilitation for anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Feb;(347):194-9.
PubMed 9520889Grant JA, Mohtadi NG. Two- to 4-year follow-up to a comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction. Am J Sports Med. 2010 Jul;38(7):1389-94. doi: 10.1177/0363546509359763. Epub 2010 Apr 1.
PubMed 20360607Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
PubMed 16002493Ferguson C, Harmer L, Seymour RB, Ellington K, Bosse MJ, and the CMC-OC Ankle Fracture Study Group. Does Physical Therapy Predict Outcomes after Ankle Fractures and Ankle Fracture-Dislocations? Podium Presentation, Orthopaedic Trauma Association Annual Meeting, October 2015.
Darter BJ, Nielsen DH, Yack HJ, Janz KF. Home-based treadmill training to improve gait performance in persons with a chronic transfemoral amputation. Arch Phys Med Rehabil. 2013 Dec;94(12):2440-2447. doi: 10.1016/j.apmr.2013.08.001. Epub 2013 Aug 13.
PubMed 23954560Ravaud P, Giraudeau B, Logeart I, Larguier JS, Rolland D, Treves R, Euller-Ziegler L, Bannwarth B, Dougados M. Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design. Ann Rheum Dis. 2004 Jun;63(6):703-8. doi: 10.1136/ard.2003.009803.
PubMed 15140778Lim HJ, Moon YI, Lee MS. Effects of home-based daily exercise therapy on joint mobility, daily activity, pain, and depression in patients with ankylosing spondylitis. Rheumatol Int. 2005 Apr;25(3):225-9. doi: 10.1007/s00296-004-0536-z. Epub 2005 Jan 14.
PubMed 15650833
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
- ClinicalTrials.gov ID
- NCT04612478
- Acronym / sponsor ID
- IRB00082966
- Conditions
- Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 3 Nov 2020 (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 compare the effectiveness and value of clinic-based physical therapy (PT) and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.
Detailed description
There is little clinical debate that patients with multiple extremity injuries or injuries with associated complex soft tissue damage or nerve deficits benefit from supervised PT. Prior research from the LEAP Study examined the impact of PT on patients with high energy trauma injuries below the distal femur.1 While the surgeons and PTs differed in their assessment of perceived need for PT,2,3 evidence demonstrates the beneficial effect of PT for this patient population.4 Research on combat-related lower extremity limb salvage patients showed a significant benefit and a higher return-to-duty rate following intense and focused rehabilitation combined with an integrated orthotic.5-7 However, the majority of lower extremity fractures seen in the military and civilian sectors are not combat related or of the severity of the Lower Extremity Assessment Project (LEAP) limb salvage patients and, thus may not require intensive, clinic-based, supervised PT treatment. Patients with isolated major lower extremity fractures may benefit from a self-guided, home-based post-injury exercise program. Studies evaluating home exercise programs for elective orthopaedic reconstruction surgery for joint replacement and anterior cruciate ligament (ACL )reconstruction have reported equivalent outcomes compared to in-person, supervised PT.8-12 Because PT resources are critical, limited, and expensive in most civilian centers, identifying the patients who would most benefit from utilizing these resources could result in savings for both the patients and the health care systems, and lead to more efficient access to PT services by the population who needs them the most. In addition to health systems benefits, patients able to achieve positive outcomes through a home-based, self-directed exercise program would experience flexibility regarding when the exercises are performed.
The purpose of this study is to compare the effectiveness and value of clinic-based PT and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.
Hypothesis: The overall hypothesis is that return to work/major activities as well as clinical and functional outcomes and health-related quality of life for patients who receive clinic-based PT will be similar to patients receiving SDEP.
Specific Aim 1: To compare the effectiveness of SDEP, exercise instructions given by physician and clinic-based PT for improving return to work/major activities, clinical and functional/performance outcomes and health-related quality of life in patients following selected lower-extremity fractures.
Specific Aim 2: To determine which sub-groups of patients, based on patient and injury characteristics, are most likely to benefit from SDEP.
Specific Aim 3: To compare the cost-effectiveness of clinic-based PT and SDEP
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic-Based Physical Therapy | Other | Behavioral: Clinic-Based PhysicalPatients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan. |
| Self-Directed Exercise Program | Other | Behavioral: Self-Directed Exercise ProgramThe full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program. The SDEP manual will provide detailed instructions on exercises, such as repetitions, frequency, and required equipment, which can be implemented in the home environment. The basis for the exercise regimen is derived from the American Academy of Orthopaedic Surgeons (AAOS) sample home based exercise program available in handout form. The program provides instructions on exercises, repetitions or duration, frequency, and required equipment which can be implemented in the home environment. |
| Observational | No intervention | –Patients who are unwilling to be randomized will be enrolled in an observational arm of the study. They will be asked to complete all baseline and follow-up assessments, and participation in formal PT or SDEP will be documented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-65 with operative fractures of the femur and tibia (to include distal femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries (44A, B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up of care performed elsewhere (within 14 days of the injury).
- All patients must be English or Spanish competent and able to be followed at the sites for at least 12 months following injury.
Key exclusion criteria (9 listed)
- Patients with Injury Severity Score (ISS)>18
- Bilateral lower-extremity injuries that preclude crutch ambulation
- Associated spine, pelvic, and/or acetabular fractures that otherwise alter weightbearing plan
- Type III B/C open fractures
- Glasgow Coma Scale <15 at time of discharge
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 |
|---|---|---|
| Self-Directed Exercise ProgramThe full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program | Behavioural | Self-Directed Exercise Program |
| Clinic-Based PhysicalPatients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan. | Behavioural | Clinic-Based Physical Therapy |
Primary outcome
Return to work/major activities
Time frame: 12 months
Measured through the rate of return to work/duty 12 months post discharge using the Work Productivity and Activity Impairment Questionnaire (WPAI)
6 secondary outcomes
Change in Quality of Life
Time frame: baseline, 3, 6 and12 months
Kinesiophobia
Time frame: baseline, 3, 6 and12 months
Time to Radiographic Fracture Healing
Time frame: 3, 6 & 12 months
Muscle Strength
Time frame: 12 months
Joint Range of Motion (ROM)
Time frame: 12 months
Resilience
Time frame: Baseline, 3, 6 & 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 31 Jan 2024.
- Background: PubMed 12477942Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
- Background: PubMed 16181933Castillo RC, MacKenzie EJ, Webb LX, Bosse MJ, Avery J; LEAP Study Group. Use and perceived need of physical therapy following severe lower-extremity trauma. Arch Phys Med Rehabil. 2005 Sep;86(9):1722-8. doi: 10.1016/j.apmr.2005.03.005.
- Background: PubMed 19875460Archer KR, Mackenzie EJ, Castillo RC, Bosse MJ; LEAP Study Group. Orthopedic surgeons and physical therapists differ in assessment of need for physical therapy after traumatic lower-extremity injury. Phys Ther. 2009 Dec;89(12):1337-49. doi: 10.2522/ptj.20080200. Epub 2009 Oct 29.
- Background: PubMed 18929015Castillo RC, MacKenzie EJ, Archer KR, Bosse MJ, Webb LX; LEAP Study Group. Evidence of beneficial effect of physical therapy after lower-extremity trauma. Arch Phys Med Rehabil. 2008 Oct;89(10):1873-9. doi: 10.1016/j.apmr.2008.01.032.
- Background: PubMed 24121984Blair JA, Patzkowski JC, Blanck RV, Owens JG, Hsu JR; Skeletal Trauma Research Consortium (STReC). Return to duty after integrated orthotic and rehabilitation initiative. J Orthop Trauma. 2014 Apr;28(4):e70-4. doi: 10.1097/BOT.0000000000000006.
- Background: PubMed 24744130Bedigrew KM, Patzkowski JC, Wilken JM, Owens JG, Blanck RV, Stinner DJ, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma? Clin Orthop Relat Res. 2014 Oct;472(10):3017-25. doi: 10.1007/s11999-014-3609-7.
- Background: PubMed 22847079Patzkowski JC, Owens JG, Blanck RV, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Deployment after limb salvage for high-energy lower-extremity trauma. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S112-5. doi: 10.1097/TA.0b013e3182606291.
- Background: PubMed 26178888Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
- Background: PubMed 9520889Fischer DA, Tewes DP, Boyd JL, Smith JP, Quick DC. Home based rehabilitation for anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1998 Feb;(347):194-9.
- Background: PubMed 20360607Grant JA, Mohtadi NG. Two- to 4-year follow-up to a comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction. Am J Sports Med. 2010 Jul;38(7):1389-94. doi: 10.1177/0363546509359763. Epub 2010 Apr 1.
- Background: PubMed 16002493Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
- BackgroundFerguson C, Harmer L, Seymour RB, Ellington K, Bosse MJ, and the CMC-OC Ankle Fracture Study Group. Does Physical Therapy Predict Outcomes after Ankle Fractures and Ankle Fracture-Dislocations? Podium Presentation, Orthopaedic Trauma Association Annual Meeting, October 2015.
- Individual participant dataSharing planned: Undecided
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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.
Rachel Seymour, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Directed Exercise Program and Clinic-Based Physical in people with Musculoskeletal Injury, run by Wake Forest University Health Sciences 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 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Return to work/major activities (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612478, which also lists 24 linked publications.
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 31 Jan 2024.