Back InjuriesNCT05359705
Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
A study testing DJO 456, Aspen 456 and DJO 464 in people with Back Injuries, run by More Foundation at 1 site in United States.
Trial summary
The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Injuries
- What is being tested?
- DJO 456, Aspen 456 and DJO 464
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 16 Oct 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 40
- English speaking
- Subjects who have read and signed IRB approved informed consent for this study
- Of appropriate body size for back brace per instructions for use
Who cannot join
- History of back pain or back injury requiring medical care within the previous 12 months
- History of spinal surgery, physical or chiropractic therapy of the back
- History of spinal spondylosis or osteoporosis
- Pregnant
- Currently Incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).
- Conditions
- Back Injuries
- Being tested
- DJO 456, Aspen 456, DJO 464, Aspen 464
- Medical subject headings
- Back Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJO 456Device
Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global
Aspen 456Device
Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products
DJO 464Device
Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global
Aspen 464Device
Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Healthy subjects who meet the Inclusion/Exclusion. Receives: Device: DJO 456; Device: Aspen 456; Device: DJO 464; Device: Aspen 464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion - Sagittal plane
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects flex their trunk relative to their pelvis in the sagittal plane.
Measured: Day 1
Extension - Sagittal plane
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects extend their trunk relative to their pelvis in the sagittal plane.
Measured: Day 1
Range of motion - Frontal plane
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects bend their trunk relative to their pelvis laterally to the right and left in the frontal plane.
Measured: Day 1
Range of motion - Transverse plane
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis laterally to the right and left in the transverse plane.
Measured: Day 1
Rotation angle while looking over shoulder
Maximum rotation angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis to look at an object placed 150 degrees behind them.
Measured: Day 1
Range of motion in the sagittal plane when rising from a chair
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rise from a chair.
Measured: Day 1
Range of motion in the sagittal plane when returning to a seated position
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects move from an upright standing position to a seated position.
Measured: Day 1
Flexion angle in the sagittal plane when touching right hallux in a seated position
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to touch their right hallux while in a seated position.
Measured: Day 1
Flexion angle in the sagittal plane when picking an object up from the floor
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to pick up a 85mm diameter object weighing 500grams from the floor from a standing position.
Measured: Day 1
Range of motion in the sagittal plane while walking on a level surface
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Measured: Day 1
Range of motion in the frontal plane while walking on a level surface
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Measured: Day 1
Range of motion in the transverse plane while walking on a level surface
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Measured: Day 1
Range of motion in the sagittal plane while ascending stairs.
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Measured: Day 1
Range of motion in the sagittal plane while descending stairs.
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Measured: Day 1
Range of motion in the frontal plane while ascending stairs.
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Measured: Day 1
Range of motion in the frontal plane while descending stairs.
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Measured: Day 1
Range of motion in the transverse plane while ascending stairs.
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Measured: Day 1
Range of motion in the transverse plane while descending stairs.
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Measured: Day 1
Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Measured: Day 1
Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Measured: Day 1
Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Measured: Day 1
Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Measured: Day 1
Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Measured: Day 1
Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Measured: Day 1
Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Measured: Day 1
Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Measured: Day 1
Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Measured: Day 1
Secondary outcomes (10)
Comfort
Subjects will be asked to provide a subjective rating of brace comfort using a 10cm visual analog comfort rating scale for each of the back braces during all ROM and ADL testing conditions. The endpoints of the scale will be labeled "Very comfortable", and "Very uncomfortable" at 0 and 10cm respectively.
Measured: Day 1
Trunk stiffness and damping - front angle
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.
Measured: Day 1
Trunk stiffness and damping - front angular velocity
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.
Measured: Day 1
Trunk stiffness and damping - front angular acceleration
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular acceleration of the upper body after force release will be measured in degrees/second/second.
Measured: Day 1
Trunk stiffness and damping - back angle
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.
Measured: Day 1
Trunk stiffness and damping - back angular velocity
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.
Measured: Day 1
Trunk stiffness and damping - back angular acceleration
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular acceleration of the upper body after force release will be measured in degrees/second/second.
Measured: Day 1
Trunk stiffness and damping - right side angle
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.
Measured: Day 1
Trunk stiffness and damping - right side angular velocity
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.
Measured: Day 1
Trunk stiffness and damping - right side angular acceleration
Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second/second.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start23 Jun 2021
- Primary completion16 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359705
- Sponsor's protocol ID
- 4051
- Status last verified
- May 2022
- First submitted
- 13 Jan 2022
- Last updated
- 6 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
- ClinicalTrials.gov ID
- NCT05359705
- Acronym / sponsor ID
- 4051
- Conditions
- Back Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 4 May 2022 (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 study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: DJO 456, Device: Aspen 456, Device: DJO 464, Device: Aspen 464Healthy subjects who meet the Inclusion/Exclusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI < 40
- English speaking
- Subjects who have read and signed IRB approved informed consent for this study
- Of appropriate body size for back brace per instructions for use
Key exclusion criteria (5 listed)
- History of back pain or back injury requiring medical care within the previous 12 months
- History of spinal surgery, physical or chiropractic therapy of the back
- History of spinal spondylosis or osteoporosis
- Pregnant
- Currently Incarcerated
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 |
|---|---|---|
| DJO 456Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global | Device | Healthy subjects |
| Aspen 456Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products | Device | Healthy subjects |
| DJO 464Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global | Device | Healthy subjects |
| Aspen 464Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products | Device | Healthy subjects |
Primary outcome
Flexion - Sagittal plane
Time frame: Day 1
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects flex their trunk relative to their pelvis in the sagittal plane.
Extension - Sagittal plane
Time frame: Day 1
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects extend their trunk relative to their pelvis in the sagittal plane.
Range of motion - Frontal plane
Time frame: Day 1
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects bend their trunk relative to their pelvis laterally to the right and left in the frontal plane.
Range of motion - Transverse plane
Time frame: Day 1
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis laterally to the right and left in the transverse plane.
Rotation angle while looking over shoulder
Time frame: Day 1
Maximum rotation angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis to look at an object placed 150 degrees behind them.
Range of motion in the sagittal plane when rising from a chair
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rise from a chair.
Range of motion in the sagittal plane when returning to a seated position
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects move from an upright standing position to a seated position.
Flexion angle in the sagittal plane when touching right hallux in a seated position
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to touch their right hallux while in a seated position.
Flexion angle in the sagittal plane when picking an object up from the floor
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to pick up a 85mm diameter object weighing 500grams from the floor from a standing position.
Range of motion in the sagittal plane while walking on a level surface
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Range of motion in the frontal plane while walking on a level surface
Time frame: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Range of motion in the transverse plane while walking on a level surface
Time frame: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Range of motion in the sagittal plane while ascending stairs.
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Range of motion in the sagittal plane while descending stairs.
Time frame: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Range of motion in the frontal plane while ascending stairs.
Time frame: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Range of motion in the frontal plane while descending stairs.
Time frame: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Range of motion in the transverse plane while ascending stairs.
Time frame: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Range of motion in the transverse plane while descending stairs.
Time frame: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.
Time frame: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.
Time frame: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.
Time frame: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.
Time frame: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
Time frame: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.
Time frame: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase
Time frame: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase
Time frame: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase
Time frame: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
10 secondary outcomes
Comfort
Time frame: Day 1
Trunk stiffness and damping - front angle
Time frame: Day 1
Trunk stiffness and damping - front angular velocity
Time frame: Day 1
Trunk stiffness and damping - front angular acceleration
Time frame: Day 1
Trunk stiffness and damping - back angle
Time frame: Day 1
Trunk stiffness and damping - back angular velocity
Time frame: Day 1
Trunk stiffness and damping - back angular acceleration
Time frame: Day 1
Trunk stiffness and damping - right side angle
Time frame: Day 1
Trunk stiffness and damping - right side angular velocity
Time frame: Day 1
Trunk stiffness and damping - right side angular acceleration
Time frame: Day 1
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 6 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DJO 456, Aspen 456 and DJO 464 in people with Back Injuries, run by More Foundation 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 4 inclusion and 5 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 6 May 2022. 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?
Flexion - Sagittal plane (time frame: Day 1). The study lists 27 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 6 May 2022.