Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Back Pain
  • Fatigue
  • Neck Pain
  • Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Objective: The purpose of this project is to examine how Integral or in-wheel suspension impacts shock, vibration, pain and fatigue in manual wheelchair users with spinal cord injury who have chronic neck or back pain, defined as continuous or daily recurring pain that has been present for more than...

Objective: The purpose of this project is to examine how Integral or in-wheel suspension impacts shock, vibration, pain and fatigue in manual wheelchair users with spinal cord injury who have chronic neck or back pain, defined as continuous or daily recurring pain that has been present for more than 3 months. Experimental Design: This study consists of 2 phases. The first phase is a non-experimental post-test only design. The second phase is a non-experimental pretest-post-test design. Methods: Thirty participants will be recruited to participate. At Baseline (visit 1) participants will be asked to complete the study questionnaires and a standardized mobility course using a pair of standard wheelchair wheels (spoked rim), SoftWheels, and Loopwheels. Vibration exposure will be measured during the various propulsion tasks. The participant will be blinded to the type of wheel being used in the trial. Participants will be given a set of in-wheel suspension wheels (either Softwheels or Loopwheels) to use at home for the 12-week intervention. Participants will use the in-wheel suspension wheels in their normal daily routine for 12-weeks. During this time, they will receive online surveys three times per week covering pain and fatigue experienced in various parts of the body. At Closeout (Visit 2), participants will be asked to return to the lab to collect final outcomes, complete an exit survey and have their wheels swapped out for their original set.

Tracking Information

NCT #
NCT04467749
Collaborators
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Alicia Koontz, PhD University of Pittsburgh