Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery

Study Overview
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Brief Summary
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Study withdrawn

Detailed Description
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Study withdrawn

Official Title
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Impact of Crutch Type on Kinematics, Electromyography, Pain, and Comfort Following Knee Arthroplasty and Anterior Cruciate Ligament Reconstruction

Conditions
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Total Knee Arthroplasty, Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Device: Study withdrawn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 45-75 years old planning to get their first total knee replacement Subjects 18-45 years old planning to get their first anterior cruciate ligament reconstruction Exclusion Criteria: Previous injury to shoulder, elbow, or wrist Current pain in shoulder, elbow, or wrist Inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), History of cerebral palsy, stroke, significant cognitive impairment, or significant visual impairment Problems with the heart or lungs Currently using a crutch or crutches, walker, or other gait aid History of using a crutch or crutches for 4 or more weeks Inability to communicate in English Current smoker Currently pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Knee Arthroplasty<br> | Device: Study withdrawn<br>* Study withdrawn<br>|
| Experimental: Anterior Cruciate Ligament Reconstruction<br> | Device: Study withdrawn<br>* Study withdrawn<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of scapular downward rotation |  | Measured during gait assessment on post-operative day 4-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral upper extremity kinematics | Hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantar flexion; measured through optical motion tracking software | Measured during gait assessment on post-operative day 4-12 | 
| Bilateral upper extremity electromyographic (EMG) activity |  | Measured during gait assessment on post-operative day 4-12 | 
| Upper extremity pain | Measurements of pain at the shoulder, elbow, and wrist using an 11-point Numerical Rating Scale (0 = no pain, 10 = extreme pain) | Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crutches, gait, mobility, adult, knee replacement, ACL tear