Spinal Cord InjuriesNCT03987243
Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
A study testing Structured Pressure Ulcer Prevention Education and Mobile Seat Interface Pressure Mapping System (IPM) in people with Spinal Cord Injuries, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Structured Pressure Ulcer Prevention Education and Mobile Seat Interface Pressure Mapping System (IPM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 11 Sep 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)
- Individuals who use a wheelchair as their primary form of mobility
- Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN
Who cannot join
- Documented active pressure ulcer of any stage at initiation of study
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).
Read the detailed description
Participants will use a mobile seat interface pressure mapping system that gives them live, real-time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts.
The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module.
The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory-based intervention has a positive impact on trunk movement and self-efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self-efficacy and movement in wheelchair users.
- Conditions
- Spinal Cord Injuries
- Being tested
- Structured Pressure Ulcer Prevention Education, Mobile Seat Interface Pressure Mapping System (IPM)
- Keywords
- Spinal Cord Injury, Seating Pressure Mapping, Pressure Injury Prevention, Seating Interface Pressure, Wheelchair User
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Pressure Ulcer Prevention EducationBehavioural
Structured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject. The education method used aligns with principles of the social cognitive theory to facilitate learning. The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development. Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way.
Mobile Seat Interface Pressure Mapping System (IPM)Other
This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface. This variable will be toggled on and off between the intervention and control phases of the study. The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4). During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases. Receives: Behavioral: Structured Pressure Ulcer Prevention Education; Other: Mobile Seat Interface Pressure Mapping System (IPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Movement
The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
Measured: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Secondary outcomes (2)
Total Vector Magnitude of Movement
The vector magnitude for each second of data during wear-times will be classified as a period of activity or inactivity.
Measured: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Forward and Lateral Tilt
Forward and lateral tilt will be assessed with the raw triaxial accelerometer data by determining the angles between gravity and the off-axes
Measured: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start14 Feb 2017
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a longitudinal, within-subject, repeated (A-B-A-B) measures design. Two interventions will be provided: structured education regarding pressure ulcer prevention through weight shifts at start of study and use of a mobile seat interface pressure map (IPM).
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Melissa M. Morrow, Ph.D., Mayo Clinic
- Investigators
- Melissa MB Morrow, PhD, Principal investigator, Mayo ClinicTamara L Vos-Draper, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987243
- Sponsor's protocol ID
- 16-007531
- Other IDs
- 1R21AG050640-01A1
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krause JS. Skin sores after spinal cord injury: relationship to life adjustment. Spinal Cord. 1998 Jan;36(1):51-6. doi: 10.1038/sj.sc.3100528.
PubMed 9471139Raghavan P, Raza WA, Ahmed YS, Chamberlain MA. Prevalence of pressure sores in a community sample of spinal injury patients. Clin Rehabil. 2003 Dec;17(8):879-84. doi: 10.1191/0269215503cr692oa.
PubMed 14682560Fuhrer MJ, Garber SL, Rintala DH, Clearman R, Hart KA. Pressure ulcers in community-resident persons with spinal cord injury: prevalence and risk factors. Arch Phys Med Rehabil. 1993 Nov;74(11):1172-7.
PubMed 8239957Akins JS, Karg PE, Brienza DM. Interface shear and pressure characteristics of wheelchair seat cushions. J Rehabil Res Dev. 2011;48(3):225-34. doi: 10.1682/jrrd.2009.09.0145.
PubMed 21480097Bates-Jensen BM, Guihan M, Garber SL, Chin AS, Burns SP. Characteristics of recurrent pressure ulcers in veterans with spinal cord injury. J Spinal Cord Med. 2009;32(1):34-42. doi: 10.1080/10790268.2009.11760750.
PubMed 19264047Mawson AR, Biundo JJ Jr, Neville P, Linares HA, Winchester Y, Lopez A. Risk factors for early occurring pressure ulcers following spinal cord injury. Am J Phys Med Rehabil. 1988 Jun;67(3):123-7. doi: 10.1097/00002060-198806000-00007.
PubMed 3377890Niazi ZB, Salzberg CA, Byrne DW, Viehbeck M. Recurrence of initial pressure ulcer in persons with spinal cord injuries. Adv Wound Care. 1997 May-Jun;10(3):38-42.
PubMed 9306777Staas WE Jr, Cioschi HM. Pressure sores--a multifaceted approach to prevention and treatment. West J Med. 1991 May;154(5):539-44.
PubMed 1830985Thomas DR. Prevention and treatment of pressure ulcers: what works? what doesn't? Cleve Clin J Med. 2001 Aug;68(8):704-7, 710-14, 717-22. doi: 10.3949/ccjm.68.8.704.
PubMed 11510528Thietje R, Giese R, Pouw M, Kaphengst C, Hosman A, Kienast B, van de Meent H, Hirschfeld S. How does knowledge about spinal cord injury-related complications develop in subjects with spinal cord injury? A descriptive analysis in 214 patients. Spinal Cord. 2011 Jan;49(1):43-8. doi: 10.1038/sc.2010.96. Epub 2010 Sep 7.
PubMed 20820180Verschueren JH, Post MW, de Groot S, van der Woude LH, van Asbeck FW, Rol M. Occurrence and predictors of pressure ulcers during primary in-patient spinal cord injury rehabilitation. Spinal Cord. 2011 Jan;49(1):106-12. doi: 10.1038/sc.2010.66. Epub 2010 Jun 8.
PubMed 20531357Consortium for Spinal Cord Medicine Clinical Practice Guidelines. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2001 Spring;24 Suppl 1:S40-101. doi: 10.1080/10790268.2001.11753592. No abstract available.
PubMed 11958176Clark FA, Jackson JM, Scott MD, Carlson ME, Atkins MS, Uhles-Tanaka D, Rubayi S. Data-based models of how pressure ulcers develop in daily-living contexts of adults with spinal cord injury. Arch Phys Med Rehabil. 2006 Nov;87(11):1516-25. doi: 10.1016/j.apmr.2006.08.329.
PubMed 17084129Dunn CA, Carlson M, Jackson JM, Clark FA. Response factors surrounding progression of pressure ulcers in community-residing adults with spinal cord injury. Am J Occup Ther. 2009 May-Jun;63(3):301-9. doi: 10.5014/ajot.63.3.301.
PubMed 19522138Stinson MD, Porter-Armstrong AP, Eakin PA. Pressure mapping systems: reliability of pressure map interpretation. Clin Rehabil. 2003 Aug;17(5):504-11. doi: 10.1191/0269215503cr643oa.
PubMed 12952156
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile and Remote Monitoring of Seating Pressure for Wheelchair Users With SCI
- ClinicalTrials.gov ID
- NCT03987243
- Acronym / sponsor ID
- 16-007531
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Seating Pressure Mapping, Pressure Injury Prevention, Seating Interface Pressure, Wheelchair User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Minnesota, National Institute on Aging (NIA)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 14 Jun 2019 (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.
This study will examine two interventions to increase weight shifts, overall trunk movement, and self-efficacy related to pressure ulcer prevention in wheelchair users with a spinal cord injury (SCI).
Detailed description
Participants will use a mobile seat interface pressure mapping system that gives them live, real-time, visual feedback on the distribution of pressure between them and their seat cushion. This type of feedback works as a compensatory strategy for lack of sensation and allows the individual to visually observe pressure distribution they are not able to feel. Additionally, the participants will be provided with structured pressure ulcer prevention education, grounded in the principles of social cognitive theory, regarding pressure ulcer risk and use of weight shifts.
The pressure mapping system, which will be used during training, provides virtual modeling of the desired outcome (reduced pressure) and is an important part of the education module.
The findings of this study will inform clinicians and investigators of whether use of mobile seat interface pressure mapping as a compensatory-based intervention has a positive impact on trunk movement and self-efficacy for completing weight shifts in wheelchair users who lack sensation. Another contribution of this work is an exploration of the relationship between self-efficacy and movement in wheelchair users.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a longitudinal, within-subject, repeated (A-B-A-B) measures design. Two interventions will be provided: structured education regarding pressure ulcer prevention through weight shifts at start of study and use of a mobile seat interface pressure map (IPM).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Structured Pressure Ulcer Prevention Education, Other: Mobile Seat Interface Pressure Mapping System (IPM)Two interventions will be provided. The first intervention is a structured education regarding pressure ulcer prevention through weight shifts at start of study. The second intervention is the use of a mobile seat interface pressure map (IPM), which will occur during two intervention phases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with a spinal cord injury (C4 and below, traumatic or non-traumatic, with onset greater than 12 months at enrollment)
- Individuals who use a wheelchair as their primary form of mobility
- Individuals who are willing to participate and able to make 2 visits to the Mayo Clinic in Rochester, MN
Key exclusion criteria (1 listed)
- Documented active pressure ulcer of any stage at initiation of study
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 |
|---|---|---|
| Structured Pressure Ulcer Prevention EducationStructured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject. The education method used aligns with principles of the social cognitive theory to facilitate learning. The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development. Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way. | Behavioural | Intervention |
| Mobile Seat Interface Pressure Mapping System (IPM)This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface. This variable will be toggled on and off between the intervention and control phases of the study. The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4). During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map | Other | Intervention |
Primary outcome
Trunk Movement
Time frame: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
The primary outcome variable, trunk movement, will be defined by the percentage of the day with active trunk movement.
2 secondary outcomes
Total Vector Magnitude of Movement
Time frame: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
Forward and Lateral Tilt
Time frame: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.
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 14 Jun 2019.
- Background: PubMed 9471139Krause JS. Skin sores after spinal cord injury: relationship to life adjustment. Spinal Cord. 1998 Jan;36(1):51-6. doi: 10.1038/sj.sc.3100528.
- Background: PubMed 14682560Raghavan P, Raza WA, Ahmed YS, Chamberlain MA. Prevalence of pressure sores in a community sample of spinal injury patients. Clin Rehabil. 2003 Dec;17(8):879-84. doi: 10.1191/0269215503cr692oa.
- Background: PubMed 8239957Fuhrer MJ, Garber SL, Rintala DH, Clearman R, Hart KA. Pressure ulcers in community-resident persons with spinal cord injury: prevalence and risk factors. Arch Phys Med Rehabil. 1993 Nov;74(11):1172-7.
- Background: PubMed 21480097Akins JS, Karg PE, Brienza DM. Interface shear and pressure characteristics of wheelchair seat cushions. J Rehabil Res Dev. 2011;48(3):225-34. doi: 10.1682/jrrd.2009.09.0145.
- Background: PubMed 19264047Bates-Jensen BM, Guihan M, Garber SL, Chin AS, Burns SP. Characteristics of recurrent pressure ulcers in veterans with spinal cord injury. J Spinal Cord Med. 2009;32(1):34-42. doi: 10.1080/10790268.2009.11760750.
- Background: PubMed 3377890Mawson AR, Biundo JJ Jr, Neville P, Linares HA, Winchester Y, Lopez A. Risk factors for early occurring pressure ulcers following spinal cord injury. Am J Phys Med Rehabil. 1988 Jun;67(3):123-7. doi: 10.1097/00002060-198806000-00007.
- Background: PubMed 9306777Niazi ZB, Salzberg CA, Byrne DW, Viehbeck M. Recurrence of initial pressure ulcer in persons with spinal cord injuries. Adv Wound Care. 1997 May-Jun;10(3):38-42.
- Background: PubMed 1830985Staas WE Jr, Cioschi HM. Pressure sores--a multifaceted approach to prevention and treatment. West J Med. 1991 May;154(5):539-44.
- Background: PubMed 11510528Thomas DR. Prevention and treatment of pressure ulcers: what works? what doesn't? Cleve Clin J Med. 2001 Aug;68(8):704-7, 710-14, 717-22. doi: 10.3949/ccjm.68.8.704.
- Background: PubMed 20820180Thietje R, Giese R, Pouw M, Kaphengst C, Hosman A, Kienast B, van de Meent H, Hirschfeld S. How does knowledge about spinal cord injury-related complications develop in subjects with spinal cord injury? A descriptive analysis in 214 patients. Spinal Cord. 2011 Jan;49(1):43-8. doi: 10.1038/sc.2010.96. Epub 2010 Sep 7.
- Background: PubMed 20531357Verschueren JH, Post MW, de Groot S, van der Woude LH, van Asbeck FW, Rol M. Occurrence and predictors of pressure ulcers during primary in-patient spinal cord injury rehabilitation. Spinal Cord. 2011 Jan;49(1):106-12. doi: 10.1038/sc.2010.66. Epub 2010 Jun 8.
- Background: PubMed 11958176Consortium for Spinal Cord Medicine Clinical Practice Guidelines. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2001 Spring;24 Suppl 1:S40-101. doi: 10.1080/10790268.2001.11753592. No abstract available.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Melissa MB Morrow, PhD principal investigator
Mayo Clinic
Tamara L Vos-Draper, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Pressure Ulcer Prevention Education and Mobile Seat Interface Pressure Mapping System (IPM) in people with Spinal Cord Injuries, run by Mayo Clinic 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 3 inclusion and 1 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 14 Jun 2019. 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?
Trunk Movement (time frame: For each phase and session combination (A1, B1, A2, B2), the daily values will be averaged over the 7 day collection period for one representative daily percentage of trunk active movement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987243, which also lists 34 linked publications.
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 14 Jun 2019.