Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures

Musculoskeletal Injury Clinical Trial

Official title:

Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612478
• Other study ID #: IRB00082966
• Secondary ID: Pro00024283
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: November 2, 2023

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Musculoskeletal Injury

Intervention

Behavioral:
• Self-Directed Exercise Program
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 Physical
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.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Greenville Health System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (24)

Archer 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. — View Citation

Bedigrew 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. — View Citation

Blair 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. — View Citation

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. — View Citation

Castillo 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. — View Citation

Castillo 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. — View Citation

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. — View Citation

Ferguson 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.

Fischer 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. — View Citation

Gleyze P, Georges T, Flurin PH, Laprelle E, Katz D, Clavert P, Charousset C, Levigne C; French Arthroscopy Society. Comparison and critical evaluation of rehabilitation and home-based exercises for treating shoulder stiffness: prospective, multicenter study with 148 cases. Orthop Traumatol Surg Res. 2011 Dec;97(8 Suppl):S182-94. doi: 10.1016/j.otsr.2011.09.005. Epub 2011 Oct 28. — View Citation

Grant 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. — View Citation

Grant 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. — View Citation

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Lim 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. — View Citation

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Patzkowski 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. — View Citation

Ravaud 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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Secondary	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.	baseline, 3, 6 and12 months
Secondary	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	baseline, 3, 6 and12 months
Secondary	Time to Radiographic Fracture Healing	Radiographs will be assessed for fracture healing.	3, 6 & 12 months
Secondary	Muscle Strength	Muscle strength will be measured using a dynamometer.	12 months
Secondary	Joint Range of Motion (ROM)	Joint range of motion will be measured using a goniomenter.	12 months
Secondary	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	Baseline, 3, 6 & 12 months