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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04258917
Other study ID # REB20-0047
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 8, 2021
Est. completion date April 11, 2022

Study information

Verified date April 2022
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study withdrawn


Description:

Study withdrawn


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 11, 2022
Est. primary completion date January 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Study withdrawn
Study withdrawn

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary University of Lethbridge

Outcome

Type Measure Description Time frame Safety issue
Other Weight-bearing lower 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
Other Torso kinematics Thoracic flexion/extension; measured through optical motion tracking software Measured during gait assessment on post-operative day 4-12
Other Spatiotemporal parameters Gait velocity, crutch stride length, weight-bearing lower extremity stride length; measured through timing lights and computer software Measured during gait assessment on post-operative day 4-12
Other Crutch comfort Measured through an 11-point Numerical Rating Scale for both crutch types (0 = extremely uncomfortable, 10 = extremely comfortable) Measured during gait assessment on post-operative day 4-12
Other Number of falls Measured at 4 weeks post-operation
Primary Range of scapular downward rotation Measured during gait assessment on post-operative day 4-12
Secondary 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
Secondary Bilateral upper extremity electromyographic (EMG) activity Measured during gait assessment on post-operative day 4-12
Secondary 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
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