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Effects of In-Wheel Suspension

Primary Purpose

Spinal Cord Injuries, Fatigue, Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suspension Wheel
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspension Wheel

Arm Description

Participants will be given a set of in-wheel suspension wheels to use in their normal daily routine for three months.

Outcomes

Primary Outcome Measures

Vibrational Dose Value (VDV)
Amount of whole body vibration exposure in units of meters/sec to power of 1.75) computed using a 3-axis accelerometer attached to wheelchair on the obstacle course.
Changes in Neck Pain
Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Changes in Upper Back Pain
Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Changes in Fatigue
Measured using the Daily Questionnaire for Pain and Fatigue. Four questions ask specifically about fatigue experienced when using the wheelchair in and outside of the home and on smooth and uneven surfaces. The scale ranges from 0 = no fatigue to 3 = extreme fatigue.

Secondary Outcome Measures

Changes in Mobility Participation in the Community
Measured using Environmental Aspects of Mobility Questionnaire (EAMQ) a 36-item questionnaire accessing frequency of encounters and avoidances to environmental features. Each feature is scored on a 5-point scale (1=never, 2 = rarely, 3 = sometimes, 4=often, 5 = always). A separate total score is determined for Encounters ranging from 21 (never encounters any feature) to 105 (always encounters all features) and Avoidances ranging from 15 (never avoids any feature) to 75 (always avoids all features).

Full Information

First Posted
July 8, 2020
Last Updated
September 6, 2023
Sponsor
University of Pittsburgh
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04467749
Brief Title
Effects of In-Wheel Suspension
Official Title
Effects of In-wheel Suspension in Reducing Vibration, Neck, and Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Fatigue, Back Pain, Neck Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suspension Wheel
Arm Type
Experimental
Arm Description
Participants will be given a set of in-wheel suspension wheels to use in their normal daily routine for three months.
Intervention Type
Other
Intervention Name(s)
Suspension Wheel
Other Intervention Name(s)
Spinergy or Loopwheel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vibrational Dose Value (VDV)
Description
Amount of whole body vibration exposure in units of meters/sec to power of 1.75) computed using a 3-axis accelerometer attached to wheelchair on the obstacle course.
Time Frame
Baseline Visit (Phase 1 Primary Outcome)
Title
Changes in Neck Pain
Description
Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Time Frame
Baseline and 12-weeks (Phase 2 Primary Outcome)
Title
Changes in Upper Back Pain
Description
Measured using the Numerical Rating Scale (NRS). The NRS measures amount of pain experienced in a body part over the last 24 hours on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Time Frame
Baseline and 12-weeks (Phase 2 Primary Outcome)
Title
Changes in Fatigue
Description
Measured using the Daily Questionnaire for Pain and Fatigue. Four questions ask specifically about fatigue experienced when using the wheelchair in and outside of the home and on smooth and uneven surfaces. The scale ranges from 0 = no fatigue to 3 = extreme fatigue.
Time Frame
Baseline and 12-weeks (Phase 2 Primary Outcome)
Secondary Outcome Measure Information:
Title
Changes in Mobility Participation in the Community
Description
Measured using Environmental Aspects of Mobility Questionnaire (EAMQ) a 36-item questionnaire accessing frequency of encounters and avoidances to environmental features. Each feature is scored on a 5-point scale (1=never, 2 = rarely, 3 = sometimes, 4=often, 5 = always). A separate total score is determined for Encounters ranging from 21 (never encounters any feature) to 105 (always encounters all features) and Avoidances ranging from 15 (never avoids any feature) to 75 (always avoids all features).
Time Frame
Baseline and 12-weeks (Phase 2 Secondary Outcome)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikitha Deepak
Phone
412-822-3700
Email
nid51@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rosemarie Cooper
Phone
412-822-3700
Email
cooperrm@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Koontz, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikitha Deepak
Phone
412-822-3700
Email
nid51@pitt.edu
First Name & Middle Initial & Last Name & Degree
Rosemarie Cooper
Phone
412-822-3700
Email
cooperrm@pitt.edu
First Name & Middle Initial & Last Name & Degree
Alicia Koontz, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in a publication related to this study, after deidentification may be shared. Requesters will be asked to submit aims and a methodologically sound proposal for which they plan to use the data to be evaluated by study team before releasing the information. The request and proposal will be directed to the corresponding author of the publication. Data requesters will also need to sign a data access agreement.
IPD Sharing Time Frame
Data will be immediately available post acceptance date of the study related publication and for a period of 5 years.
IPD Sharing Access Criteria
Requesters must provide methodologically sound aims and proposal describing use of the data. They also need to sign a data access agreement.

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Effects of In-Wheel Suspension

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