Trials / Completed
CompletedNCT04467749
Effects of In-Wheel Suspension
Effects of In-wheel Suspension in Reducing Vibration, Neck, and Back Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Suspension Wheel | Participants will be given a pair of Spinergy or Loopwheels to use during the 12-week intervention period. The Spinergy wheels consist of a lightweight carbon fiber material with natural shock absorbing properties. Loopwheels offer a rigid rim, a mid-wheel shock absorbing hub and three in-wheel loops that work as a self-correcting system when encountering uneven ground. |
Timeline
- Start date
- 2022-07-14
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
- First posted
- 2020-07-13
- Last updated
- 2024-02-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04467749. Inclusion in this directory is not an endorsement.