Spinal Cord InjuriesNCT05068648
Wheelchair Backs That Support the Spinal Curves
A study testing Manual Wheelchair (MWC) backrest configuration in people with Spinal Cord Injuries, run by Craig Hospital at 3 sites in United States.
Trial summary
The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Manual Wheelchair (MWC) backrest configuration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2021to 7 Jan 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full time manual wheelchair users
- Motor complete SCI from C6-T4
- Age 18-70 at time of testing
- Time since injury > 3 month at time of testing
Who cannot join
- Weight >250 pounds
- Current pressure ulcer at time of testing
- Significant shoulder pain that precludes independent mobility at time of testing
- Insufficient range of motion to achieve neutral pelvis and spine at time of testing
- Orthopedic restrictions requiring a brace that would impact functional outcome measures
- Shoulder flexion range of motion <120 degrees at time of testing
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- PSIS-to-Inferior Angle of scapula measurement less than 8 inches or greater than 16 inches
- Cognitive deficits or visual impairment that would impair ability to give informed consent or to follow simple instructions during testing
- Children, pregnant women and prisoners will not participate in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Craig Hospital
Englewood, Colorado, 80113
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Wheelchair Backs That Support the Spinal Curves: Assessing Postural and Functional Changes
The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).
Read the detailed description
A properly fit wheelchair and seating system can have a profound impact on the daily life of people with spinal cord injury (SCI). A backrest that supports the natural spinal curves is thought to enhance posture, functional mobility, and comfort for manual wheelchair (MWC) users. In fact, therapists routinely prescribe after-market posture-backs based on clinical reasoning. However, there is little research comparing the efficacy of an after-market posture-back to the standard upholstery back, and it is becoming increasingly difficult to justify these to group insurance payers.
Based on this, investigators performed a pilot study to investigate whether there were postural and/or functional differences between using a standard upholstery WC back and an after-market solid posture-back. The results of that study have been presented at the American Congress of Rehabilitation Medicine (ACRM) annual conference in November 2019 and the Combined Sections Meeting (CSM) of the American Physical Therapy Association (APTA) in February 2020, and were also published in the Journal of Spinal Cord Medicine in 2020.
Although the results of that study demonstrated clinical relevance and statistical trends for improvements in postural alignment and functional outcomes when using a solid back, there was not enough power to establish statistical significance. It also did not evaluate the effect of backrest height and position or depth of contour in order to inform clinical practice. The overall objective of this fully powered clinical trial is to further investigate if using a solid backrest on MWC will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest; and to explore the impact of overall back height, seat gap, and contour when using a solid backrest.
- Conditions
- Spinal Cord Injuries
- Being tested
- Manual Wheelchair (MWC) backrest configuration
- 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.
Manual Wheelchair (MWC) backrest configurationOther
Wheelchair backrest fitting, postural and functional assessment
| Study group | Role | What they receive |
|---|---|---|
| MWC Configuration 1 | Active comparator | standard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle Receives: Other: Manual Wheelchair (MWC) backrest configuration |
| MWC Configuration 2 | Active comparator | active contour back positioned with seat gap and with free scapulae Receives: Other: Manual Wheelchair (MWC) backrest configuration |
| MWC Configuration 3 | Active comparator | active contour back positioned with seat gap and with blocked scapulae Receives: Other: Manual Wheelchair (MWC) backrest configuration |
| MWC Configuration 4 | Active comparator | deep contour back positioned with seat gap and with free scapulae Receives: Other: Manual Wheelchair (MWC) backrest configuration |
| MWC Configuration 5 | Active comparator | deep contour back positioned without seat gap and with free scapulae Receives: Other: Manual Wheelchair (MWC) backrest configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Angle
Measured: Throughout study completion; average of 2 years.
Frontal Pelvic Angle
Measured: Throughout study completion; average of 2 years.
Secondary outcomes (6)
Spinal Angle of Kyphosis
Measured: Throughout study completion; average of 2 years.
Frontal Sternal Angle
Measured: Throughout study completion; average of 2 years.
Vertical Forward Reach Test (VFRT)
Measured: Throughout study completion; average of 2 years.
One Stroke Push Test
Measured: Throughout study completion; average of 2 years.
Timed Forward Wheeling
Measured: Throughout study completion; average of 2 years.
Timed ramp ascent
Measured: Throughout study completion; average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Dec 2021
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation, Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Candace Tefertiller, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068648
- Sponsor's protocol ID
- IRB#1788302
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair Backs That Support the Spinal Curves: Assessing Postural and Functional Changes
- ClinicalTrials.gov ID
- NCT05068648
- Acronym / sponsor ID
- IRB#1788302
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- Kessler Institute for Rehabilitation, Shirley Ryan AbilityLab
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 6 Oct 2021 (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.
The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).
Detailed description
A properly fit wheelchair and seating system can have a profound impact on the daily life of people with spinal cord injury (SCI). A backrest that supports the natural spinal curves is thought to enhance posture, functional mobility, and comfort for manual wheelchair (MWC) users. In fact, therapists routinely prescribe after-market posture-backs based on clinical reasoning. However, there is little research comparing the efficacy of an after-market posture-back to the standard upholstery back, and it is becoming increasingly difficult to justify these to group insurance payers.
Based on this, investigators performed a pilot study to investigate whether there were postural and/or functional differences between using a standard upholstery WC back and an after-market solid posture-back. The results of that study have been presented at the American Congress of Rehabilitation Medicine (ACRM) annual conference in November 2019 and the Combined Sections Meeting (CSM) of the American Physical Therapy Association (APTA) in February 2020, and were also published in the Journal of Spinal Cord Medicine in 2020.
Although the results of that study demonstrated clinical relevance and statistical trends for improvements in postural alignment and functional outcomes when using a solid back, there was not enough power to establish statistical significance. It also did not evaluate the effect of backrest height and position or depth of contour in order to inform clinical practice. The overall objective of this fully powered clinical trial is to further investigate if using a solid backrest on MWC will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest; and to explore the impact of overall back height, seat gap, and contour when using a solid backrest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MWC Configuration 1 | Active comparator | Other: Manual Wheelchair (MWC) backrest configurationstandard upholstery back that promotes posterior pelvic tilt set at or below cushion level and 1" above inferior angle |
| MWC Configuration 2 | Active comparator | Other: Manual Wheelchair (MWC) backrest configurationactive contour back positioned with seat gap and with free scapulae |
| MWC Configuration 3 | Active comparator | Other: Manual Wheelchair (MWC) backrest configurationactive contour back positioned with seat gap and with blocked scapulae |
| MWC Configuration 4 | Active comparator | Other: Manual Wheelchair (MWC) backrest configurationdeep contour back positioned with seat gap and with free scapulae |
| MWC Configuration 5 | Active comparator | Other: Manual Wheelchair (MWC) backrest configurationdeep contour back positioned without seat gap and with free scapulae |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Full time manual wheelchair users
- Motor complete SCI from C6-T4
- Age 18-70 at time of testing
- Time since injury > 3 month at time of testing
Key exclusion criteria (9 listed)
- Weight >250 pounds
- Current pressure ulcer at time of testing
- Significant shoulder pain that precludes independent mobility at time of testing
- Insufficient range of motion to achieve neutral pelvis and spine at time of testing
- Orthopedic restrictions requiring a brace that would impact functional outcome measures
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 |
|---|---|---|
| Manual Wheelchair (MWC) backrest configurationWheelchair backrest fitting, postural and functional assessment | Other | MWC Configuration 1, MWC Configuration 2, MWC Configuration 3, MWC Configuration 4, MWC Configuration 5 |
Primary outcome
Pelvic Angle
Time frame: Throughout study completion; average of 2 years.
Frontal Pelvic Angle
Time frame: Throughout study completion; average of 2 years.
6 secondary outcomes
Spinal Angle of Kyphosis
Time frame: Throughout study completion; average of 2 years.
Frontal Sternal Angle
Time frame: Throughout study completion; average of 2 years.
Vertical Forward Reach Test (VFRT)
Time frame: Throughout study completion; average of 2 years.
One Stroke Push Test
Time frame: Throughout study completion; average of 2 years.
Timed Forward Wheeling
Time frame: Throughout study completion; average of 2 years.
Timed ramp ascent
Time frame: Throughout study completion; average of 2 years.
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 24 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Wheelchair (MWC) backrest configuration in people with Spinal Cord Injuries, run by Craig Hospital at 3 sites 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 4 inclusion and 9 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Pelvic Angle (time frame: Throughout study completion; average of 2 years.). The study lists 2 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 24 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.