Ankylosing SpondylitisNCT03159767
A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis
A study testing ViMove Spinal Sensor in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Dr Philip Gardiner at 1 site in United Kingdom.
Trial summary
This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankylosing Spondylitis, Axial Spondyloarthritis
- What is being tested?
- ViMove Spinal Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2017to 2 May 2018
- 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
- -Confirmed diagnosis of axSpA according to the ASAS criteria
Who cannot join
- Severe joint or spinal pain at the time of the study
- Severely restricted hip movement
- History of previous vertebral fracture
- History of previous spinal surgery
- Major scoliosis deformity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, BT47 6SB
About this study
Official title: Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.
Read the detailed description
One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.
The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis
- Being tested
- ViMove Spinal Sensor
- Medical subject headings
- Spondylitis, Ankylosing, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViMove Spinal SensorDevice
Sensors will be used to measure spinal movement
| Study group | Role | What they receive |
|---|---|---|
| Spinal Mobility Measurement: Rater A | Experimental | All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. Receives: Device: ViMove Spinal Sensor |
| Spinal Mobility Measurement: Rater B | Experimental | All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. Receives: Device: ViMove Spinal Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability for measurement of lumbar spine range of movement
ICC for lumbar side flexion and forward flexion expected to be >0.8
Measured: 2 weeks
Secondary outcomes (4)
Inter-rater reliability for measurement of lumbar spine rotational range of movement
ICC for spinal rotation expected to be >0.8
Measured: 2 weeks
Reliability of IMU metrology index non-inferior to reliability of BASMI
Measurements obtained using IMUs are at least as reliable as the BASMI tape measure test
Measured: 2 weeks
Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI
We will compare the metrology indices in the strength of correlation with the BASDAI components of pain and stiffness.
Measured: 2 weeks
Inter-rater reliability for measurement of cervical rotation range of movement
ICC for cervical rotation expected to be >0.8
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start24 May 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Philip Gardiner
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Sponsor-investigator, Dr Philip Gardiner, Western Health and Social Care Trust
- Investigators
- Philip Gardiner, MD, Principal investigator, Western HSCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159767
- Sponsor's protocol ID
- WT 15/28
- Status last verified
- Dec 2018
- First submitted
- 16 May 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
- ClinicalTrials.gov ID
- NCT03159767
- Acronym / sponsor ID
- WT 15/28
- Conditions
- Ankylosing Spondylitis, Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr Philip GardinerUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- 24 May 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 19 May 2017 (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 is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.
Detailed description
One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.
The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
| Arm | Type | Receives |
|---|---|---|
| Spinal Mobility Measurement: Rater A | Experimental | Device: ViMove Spinal SensorAll patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. |
| Spinal Mobility Measurement: Rater B | Experimental | Device: ViMove Spinal SensorAll patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Confirmed diagnosis of axSpA according to the ASAS criteria
Key exclusion criteria (6 listed)
- Severe joint or spinal pain at the time of the study
- Severely restricted hip movement
- History of previous vertebral fracture
- History of previous spinal surgery
- Major scoliosis deformity
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 |
|---|---|---|
| ViMove Spinal SensorSensors will be used to measure spinal movement | Device | Spinal Mobility Measurement: Rater A, Spinal Mobility Measurement: Rater B |
Primary outcome
Inter-rater reliability for measurement of lumbar spine range of movement
Time frame: 2 weeks
ICC for lumbar side flexion and forward flexion expected to be >0.8
4 secondary outcomes
Inter-rater reliability for measurement of lumbar spine rotational range of movement
Time frame: 2 weeks
Reliability of IMU metrology index non-inferior to reliability of BASMI
Time frame: 2 weeks
Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI
Time frame: 2 weeks
Inter-rater reliability for measurement of cervical rotation range of movement
Time frame: 2 weeks
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 2 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Ankylosing Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
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.
Philip Gardiner, MD principal investigator
Western HSCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViMove Spinal Sensor in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Dr Philip Gardiner at 1 site in United Kingdom.
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 1 inclusion and 6 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 2 Jan 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 Kingdom. 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?
Inter-rater reliability for measurement of lumbar spine range of movement (time frame: 2 weeks). 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 2 Jan 2019.