Spinal Cord InjuriesNCT04467749
Effects of In-Wheel Suspension
A study testing Suspension Wheel in people with Spinal Cord Injuries and Fatigue, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Fatigue, Back Pain
- What is being tested?
- Suspension Wheel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Effects of In-wheel Suspension in Reducing Vibration, Neck, and Back Pain
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.
Read the 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
- Spinal Cord Injuries, Fatigue, Back Pain, Neck Pain
- Being tested
- Suspension Wheel
- Medical subject headings
- Spinal Cord Injuries, Fatigue, Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension WheelOther
Also called Spinergy or Loopwheel
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.
| Study group | Role | What they receive |
|---|---|---|
| Suspension Wheel | Experimental | Participants will be given a set of in-wheel suspension wheels to use in their normal daily routine for three months. Receives: Other: Suspension Wheel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Visit (Phase 1 Primary Outcome)
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.
Measured: Baseline and 12-weeks (Phase 2 Primary Outcome)
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.
Measured: Baseline and 12-weeks (Phase 2 Primary Outcome)
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.
Measured: Baseline and 12-weeks (Phase 2 Primary Outcome)
Secondary outcomes (1)
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).
Measured: Baseline and 12-weeks (Phase 2 Secondary Outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 Jul 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Alicia Koontz, University of Pittsburgh
- Investigators
- Alicia Koontz, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467749
- Sponsor's protocol ID
- STUDY20020199
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of In-wheel Suspension in Reducing Vibration, Neck, and Back Pain
- ClinicalTrials.gov ID
- NCT04467749
- Acronym / sponsor ID
- STUDY20020199
- Conditions
- Spinal Cord Injuries, Fatigue, Back Pain, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspension Wheel | Experimental | Other: Suspension WheelParticipants will be given a set of in-wheel suspension wheels to use in their normal daily routine for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suspension WheelAlso: Spinergy or LoopwheelParticipants 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. | Other | Suspension Wheel |
Primary outcome
Vibrational Dose Value (VDV)
Time frame: Baseline Visit (Phase 1 Primary Outcome)
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
Time frame: Baseline and 12-weeks (Phase 2 Primary Outcome)
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
Time frame: Baseline and 12-weeks (Phase 2 Primary Outcome)
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
Time frame: Baseline and 12-weeks (Phase 2 Primary Outcome)
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.
1 secondary outcome
Changes in Mobility Participation in the Community
Time frame: Baseline and 12-weeks (Phase 2 Secondary Outcome)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Spinal Cord Injuries
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Koontz, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suspension Wheel in people with Spinal Cord Injuries and Fatigue, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibrational Dose Value (VDV) (time frame: Baseline Visit (Phase 1 Primary Outcome)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.