A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis

NCT ID: NCT03159767

Last Updated: 2019-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2018-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis Axial Spondyloarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors
Each physiotherapist rater will have to independently attach the sensors to the participant's spine before testing, and no positioning marks will be left on the patient in between tests or between visits. They will work in different rooms and will not have access to earlier results.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal Mobility Measurement: Rater A

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Group Type EXPERIMENTAL

ViMove Spinal Sensor

Intervention Type DEVICE

Sensors will be used to measure spinal movement

Spinal Mobility Measurement: Rater B

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Group Type EXPERIMENTAL

ViMove Spinal Sensor

Intervention Type DEVICE

Sensors will be used to measure spinal movement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ViMove Spinal Sensor

Sensors will be used to measure spinal movement

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Confirmed diagnosis of axSpA according to the ASAS criteria

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ulster

OTHER

Sponsor Role collaborator

Dr Philip Gardiner

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Philip Gardiner

Consultant Rheumatologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Gardiner, MD

Role: PRINCIPAL_INVESTIGATOR

Western HSCT

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Rheumatology, Altnagelvin Hospital

Londonderry, N.Ireland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WT 15/28

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-Invasive Stimulation for Improving Motor Function
NCT03592173 ACTIVE_NOT_RECRUITING PHASE2