Joint Pain, Trouble Balancing
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEvenup
Orthotic which increases effective leg length.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Both patients and surgeons are aware whether they are being assigned to the control group or the experimental group
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* must be weight bearing as tolerated and treated for at least 2 weeks in a controlled ankle movement boot.
Exclusion criteria
* unwilling to participate * being treated for an Achilles tendon rupture (and therefore being treated in a controlled ankle boot with heel lifts) * member of a special population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Balance | 2 weeks | Patient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance). |
| Patient Reported Pain | 2 weeks | Patient reported assessment of joint pain while wearing the controlled ankle movement boot on scales of 1 - 10 (higher values indicate more pain). |
Countries
United States
Participant flow
Pre-assignment details
Enrollment continued until the study met protocol requirement.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients who received the orthotic device. | 49 |
| Control Patients who did not receive the orthotic device. | 46 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 2.5 | 48.8 years STANDARD_DEVIATION 2.33 | 47.9 years STANDARD_DEVIATION 1.7 |
| Condition is tibiotalar or above Condition at or proximal to tibiotalar joint | 28 Participants | 26 Participants | 54 Participants |
| Condition is tibiotalar or above Condition predominantly below or distal to tibiotalar joint | 21 Participants | 20 Participants | 41 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Acute Achilles tendon rupture | 0 Participants | 4 Participants | 4 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Ankle Impingement | 2 Participants | 1 Participants | 3 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Ankle instability | 2 Participants | 0 Participants | 2 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Ankle sprain | 6 Participants | 8 Participants | 14 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Foot fracture | 9 Participants | 8 Participants | 17 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Foot sprain | 0 Participants | 2 Participants | 2 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Hindfoot arthritis | 2 Participants | 1 Participants | 3 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Malleolar fracture | 9 Participants | 10 Participants | 19 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Midfoot arthritis | 1 Participants | 2 Participants | 3 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Other | 4 Participants | 4 Participants | 8 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Peroneal pathology | 2 Participants | 1 Participants | 3 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Plantar fasciitis | 1 Participants | 0 Participants | 1 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Posterior tibial tendon dysfunction | 3 Participants | 4 Participants | 7 Participants |
| Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc. Tibiotalar arthritis | 8 Participants | 1 Participants | 9 Participants |
| Postoperative versus nonoperative management Nonoperative | 32 Participants | 27 Participants | 59 Participants |
| Postoperative versus nonoperative management Postoperative | 17 Participants | 19 Participants | 36 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 49 participants | 46 participants | 95 participants |
| Sex: Female, Male Female | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 46 |
| other Total, other adverse events | 0 / 49 | 0 / 46 |
| serious Total, serious adverse events | 0 / 49 | 0 / 46 |
Outcome results
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).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthotic Group | Patient Reported Balance | 3.0 units on a scale | Standard Deviation 1.7 |
| Control | Patient Reported Balance | 2.1 units on a scale | Standard Deviation 1.7 |
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).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthotic Group | Patient Reported Pain | 4.9 score on a scale | Standard Deviation 5.6 |
| Control | Patient Reported Pain | 3.9 score on a scale | Standard Deviation 5.1 |