Effects of In-Wheel Suspension

  • STATUS
    Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    30
  • sponsor
    University of Pittsburgh
Updated on 4 October 2022
fatigue
back pain
shock
spinal cord
injuries
spinal cord disorder
neck pain

Summary

Manual wheelchairs allow individuals with spinal cord injuries (SCI) to safely and effectively access their environment. However, continual exposure to whole body vibration (WBV) is one of many contributing factors to neck pain, back pain, and fatigue in wheelchair users with SCI.

Vibration-reducing in-wheel suspension has the potential to mitigate issues associated with long-term manual wheelchair propulsion. Evidence is lacking on how well these systems work for reducing harmful shock and vibration, pain and fatigue. The purpose of this study is to examine how these wheels change the vibration levels manual wheelchair users are exposed to and how they impact pain and fatigue.

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 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), Spinergy lightweight carbon fiber wheels, 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 wheels (either Spinergy 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.

Details
Condition Spinal Cord Injuries, Fatigue, Back Pain, Neck Pain
Treatment Suspension Wheel
Clinical Study IdentifierNCT04467749
SponsorUniversity of Pittsburgh
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

have neurological impairment secondary to a traumatic SCI
have a SCI which occurred or was diagnosed over one year prior to the start of the study
uses a manual wheelchair as a primary means of mobility (at least 30 hours per week but not necessarily always in motion)
uses a manual wheelchair with 24- or 25-inch quick release wheels
uses a manual wheelchair that does not have suspension elements in the frame
weighs under 265 pounds (maximum weight limit of the suspension wheels)
has moderate chronic neck and/or back pain
proficient in English

Exclusion Criteria

History of fractures or dislocations in the shoulder, elbow and wrist from which the participant has not fully recovered (i.e. the participant may no longer experience pain or limited/altered function due to the injury)
upper limb pain that interferes with the ability to propel
severe cognitive limitations
current or recent (within the last 6 months) history of pressure sores
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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