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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04258917
• Other study ID #: REB20-0047
• Status: Withdrawn
• Phase: N/A
• 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
• 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Study withdrawn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Study withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Total Knee Arthroplasty

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• Study withdrawn
Study withdrawn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