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

April 11, 2022 updated by: Ranita Manocha, University of Calgary

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

Study withdrawn

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study withdrawn

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total Knee Arthroplasty
Device: Study withdrawn
Study withdrawn
Experimental: Anterior Cruciate Ligament Reconstruction
Device: Study withdrawn
Study withdrawn

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral upper extremity kinematics
Time Frame: Measured during gait assessment on post-operative day 4-12
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
Time Frame: Measured during gait assessment on post-operative day 4-12
Measured during gait assessment on post-operative day 4-12
Upper extremity pain
Time Frame: Measured at 3 time points: pre-operative, during gait assessment, and 4 weeks post-operative
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-bearing lower extremity kinematics
Time Frame: Measured during gait assessment on post-operative day 4-12
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
Torso kinematics
Time Frame: Measured during gait assessment on post-operative day 4-12
Thoracic flexion/extension; measured through optical motion tracking software
Measured during gait assessment on post-operative day 4-12
Spatiotemporal parameters
Time Frame: Measured during gait assessment on post-operative day 4-12
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
Crutch comfort
Time Frame: Measured during gait assessment on post-operative day 4-12
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
Number of falls
Time Frame: Measured at 4 weeks post-operation
Measured at 4 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

University of Lethbridge

Investigators

  • Principal Investigator: Ranita Manocha, MD, MSc, Department of Clinical Neurosciences, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Actual)

January 8, 2022

Study Completion (Actual)

April 11, 2022

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB20-0047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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