Spinal Cord InjuriesNCT03962582
Supportive Wheelchair Back Compared to Fabric Back
A study testing Matrix back in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt. 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?
- Matrix back
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 30 Mar 2019
- 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
- complete spinal cord injury with levels
- Full time wheelchair users
- English speaking in order to understand the consent
Who cannot join
- Over 250 pounds in body weight
- Inability to grip a wheelchair push rim
- Individual with pressure ulcer
- Individual with shoulder pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison
This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.
Read the detailed description
Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.
- Conditions
- Spinal Cord Injuries
- Being tested
- Matrix back
- 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.
Matrix backDevice
The Matrix back will replace the individual's back and the measures will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Back Comparison | Experimental | Motion Concepts matrx back to be attached to individual's wheelchair in place of the individual's back. It will be adjusted for size and to support the spinal curves as compared to a fabric back Receives: Device: Matrix back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Body Measurements performed.
Angle measurements will be taken when sitting. These include the pelvic angle (femur to pelvis) and Spinal Angle of Kyphosis (femur to acromion).
Measured: 2 hour session (one visit)
Vertical Forward Reach Test (VFRT):
Assesses stability by measuring the maximum distance an individual can reach forward vertically (upward) while sitting in a fixed position.
Measured: 2 hour session (one visit)
Breathing status:
An instrument called a spirometer is placed into the mouth with the nose clipped and the individual is instructed to take a deep breath and blow out. Peak effort flow, peak cough flow, and functional capacity will be recorded.
Measured: 2 hour session (one visit)
One stroke push:
This measures how far the wheelchair moves forward with one stroke over carpet.
Measured: 2 hour session (one visit)
Timed forward Wheeling/Wheelchair Propulsion Test (WPT):
The WPT is a brief test measuring the number of wheelchair pushes and time needed to cross a distance of 23 meters
Measured: 2 hour session (one visit)
Ramp Ascent (forward wheeling
This is a timed test on a 10.3 meter ramp with a 1:13 grade slope
Measured: 2 hour session (one visit)
Pain Scale:
The participant will rate any pain felt while sitting in the test wheelchairs after all activities using a numerical scale of 0-10, with 0 being no pain.
Measured: 2 hour session (one visit)
Survey
The study team developed a survey for patients to fill out asking questions such as comfort of back support and opinions of practicality of back support.
Measured: 2 hour session (one visit)
Secondary outcomes (1)
Breathing status:
Pulse oximetry will be taken with the person sitting in each testing wheelchair.
Measured: 2 hour session (one visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Dec 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- comparing two different back support to access if there are postural and functional differences.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Craig Hospital, Motion Concepts, The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Jessica Pedersen, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962582
- Sponsor's protocol ID
- STU00205806
- Status last verified
- May 2019
- First submitted
- 22 Apr 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison
- ClinicalTrials.gov ID
- NCT03962582
- Acronym / sponsor ID
- STU00205806
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Craig Hospital, Motion Concepts, The Craig H. Neilsen Foundation
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 24 May 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 tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.
Detailed description
Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- comparing two different back support to access if there are postural and functional differences.
| Arm | Type | Receives |
|---|---|---|
| Supportive Back Comparison | Experimental | Device: Matrix backMotion Concepts matrx back to be attached to individual's wheelchair in place of the individual's back. It will be adjusted for size and to support the spinal curves as compared to a fabric back |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- complete spinal cord injury with levels
- Full time wheelchair users
- English speaking in order to understand the consent
Key exclusion criteria (4 listed)
- Over 250 pounds in body weight
- Inability to grip a wheelchair push rim
- Individual with pressure ulcer
- Individual with shoulder pain
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 |
|---|---|---|
| Matrix backThe Matrix back will replace the individual's back and the measures will be taken. | Device | Supportive Back Comparison |
Primary outcome
Seated Body Measurements performed.
Time frame: 2 hour session (one visit)
Angle measurements will be taken when sitting. These include the pelvic angle (femur to pelvis) and Spinal Angle of Kyphosis (femur to acromion).
Vertical Forward Reach Test (VFRT):
Time frame: 2 hour session (one visit)
Assesses stability by measuring the maximum distance an individual can reach forward vertically (upward) while sitting in a fixed position.
Breathing status:
Time frame: 2 hour session (one visit)
An instrument called a spirometer is placed into the mouth with the nose clipped and the individual is instructed to take a deep breath and blow out. Peak effort flow, peak cough flow, and functional capacity will be recorded.
One stroke push:
Time frame: 2 hour session (one visit)
This measures how far the wheelchair moves forward with one stroke over carpet.
Timed forward Wheeling/Wheelchair Propulsion Test (WPT):
Time frame: 2 hour session (one visit)
The WPT is a brief test measuring the number of wheelchair pushes and time needed to cross a distance of 23 meters
Ramp Ascent (forward wheeling
Time frame: 2 hour session (one visit)
This is a timed test on a 10.3 meter ramp with a 1:13 grade slope
Pain Scale:
Time frame: 2 hour session (one visit)
The participant will rate any pain felt while sitting in the test wheelchairs after all activities using a numerical scale of 0-10, with 0 being no pain.
Survey
Time frame: 2 hour session (one visit)
The study team developed a survey for patients to fill out asking questions such as comfort of back support and opinions of practicality of back support.
1 secondary outcome
Breathing status:
Time frame: 2 hour session (one visit)
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 May 2019.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix back in people with Spinal Cord Injuries, run by Shirley Ryan AbilityLab 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 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 24 May 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?
Seated Body Measurements performed. (time frame: 2 hour session (one visit)). The study lists 8 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 May 2019.