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Patients who undergo foot and ankle surgery are often made weight-bearing as tolerated (WBAT) in a controlled ankle movement (CAM) boot during their recovery and rehabilitation process. However, some patients may experience pain and discomfort while wearing the CAM boot. A possible cause for this pain is that the boot elevates the injured foot higher than the other foot in the normal shoe. This uneven walking plane can lead to an abnormal gait or walking pattern, and may potentially lead to pain. Our goal is the investigate if using a leg-length-evening orthotic can improve balance and/or decrease the development of pain in the legs and spine for patients who are WBAT in a CAM boot.
Patients with foot and ankle injuries are often made weight-bearing as tolerated (WBAT) in a controlled ankle movement (CAM) boot at some point during their recovery and rehabilitation period. While WBAT in a CAM boot, patients often experience an asymmetric gait associated with the effective leg length discrepancy between the booted extremity (longer) and the contralateral extremity with a regular shoe (shorter). This asymmetry may cause balance problems or place strain on the patient's joints resulting in back, knee, and hip pain.
An orthotic has been designed that is added to the outside of a regular shoe in order to eliminate the effective leg length discrepancy between the booted extremity and the contralateral limb. Although this specific orthotic has not been studied, some proof of concept lies in studies that show that back pain can be managed with foot orthotics. The purpose of this study is to determine if using the leg-length-evening orthotic can improve balance and/or decrease the development of pain in the lower extremities and spine for patients who are WBAT in a CAM boot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthotic Group | Experimental | Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb. |
|
| Control | No Intervention | Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evenup | Device | Orthotic which increases effective leg length. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Balance | Patient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance). | 2 weeks |
| Patient Reported Pain | Patient reported assessment of joint pain while wearing the controlled ankle movement boot on scales of 1 - 10 (higher values indicate more pain). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamran S Hamid, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10493142 | Background | White R, Schuren J, Wardlaw D, Diamandopoulos Z, Anderson R. Biomechanical assessment of gait in below-knee walking casts. Prosthet Orthot Int. 1999 Aug;23(2):142-51. doi: 10.3109/03093649909071626. | |
| 23830710 | Background | Ferrari R. Effect of customized foot orthotics in addition to usual care for the management of chronic low back pain following work-related low back injury. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):359-63. doi: 10.1016/j.jmpt.2013.06.002. Epub 2013 Jul 3. |
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Enrollment continued until the study met protocol requirement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Patients who received the orthotic device |
| FG001 | Control Group | Patients who did not receive the orthotic device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients who received the orthotic device. |
| BG001 | Control | Patients who did not receive the orthotic device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Balance | Patient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
Adverse events were collected two weeks after consent/baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orthotic Group | Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb. Evenup: Orthotic which increases effective leg length. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel D. Bohl | Rush University Medical Center | 414.640.7245 | danielbohl@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 31, 2020 | May 15, 2021 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Subjects are randomly assigned to two groups using a blocked randomization schedule.
Subjects assigned to the control group receive the standard treatment for their condition, which must be at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot in order for them to meet inclusion criteria.
Subjects assigned to the experimental group receive the orthotic for use on the contralateral limb, which is the only alteration to their treatment of at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot (required to meet inclusion criteria).
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Both patients and surgeons are aware whether they are being assigned to the control group or the experimental group
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| 28465224 | Background | Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30. |
| 17693336 | Background | Ferrari R. Responsiveness of the short-form 36 and oswestry disability questionnaire in chronic nonspecific low back and lower limb pain treated with customized foot orthotics. J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):456-8. doi: 10.1016/j.jmpt.2007.03.016. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. | Count of Participants | Participants |
|
| Condition is tibiotalar or above | Count of Participants | Participants |
|
| Postoperative versus nonoperative management | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Patient Reported Pain | Patient reported assessment of joint pain while wearing the controlled ankle movement boot on scales of 1 - 10 (higher values indicate more pain). | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Control | Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic) | 0 | 46 | 0 | 46 | 0 | 46 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ankle sprain |
|
| Tibiotalar arthritis |
|
| Posterior tibial tendon dysfunction |
|
| Acute Achilles tendon rupture |
|
| Hindfoot arthritis |
|
| Midfoot arthritis |
|
| Peroneal pathology |
|
| Ankle Impingement |
|
| Ankle instability |
|
| Foot sprain |
|
| Other |
|
| Plantar fasciitis |
|