Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).

November 6, 2018 updated by: Ciaran Brennan, St. James's Hospital, Ireland

A Feasibility Study to Investigate the Use of Salaso to Increase Access to Physiotherapy and Increase Compliance to Exercise Prescription and Physical Activity in the Management of Ankylosing Spondylitis (AS).

This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.

The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.

Descriptive statistics will be used to record and analyse the study data, using SPSS software.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland
        • Recruiting
        • Physiotherapy Department, Saint James's Hospital
        • Contact:
          • Ciarán Brennan, MSc, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Ankylosing Spondylitis

Exclusion Criteria:

  • Previous spinal surgery
  • Spondylolisthesis
  • Unwillingness to participate
  • Unable to complete self-report questionnaires
  • Progressive neurological deficit
  • Neurological disease
  • Cauda equina syndrome
  • Unable to exercise on medical grounds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Physiotherapy via the Salaso Apllication Intervention

All participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required.

This will continue for the 6-month duration of the intervention.
Other: Physiotherapy

Participants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use.

Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes.

After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study.

Other Names:
  • Salaso

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Metrology Index
Time Frame: 6 months
Measure of spinal mobility
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index
Time Frame: 6 months
Measuring disease activity in AS
6 months
Bath Ankylosing Spondylitis Functional Index
Time Frame: 6 months
Measuring functional activity in AS
6 months
Arthritis Self-Efficacy Scale (ASES)
Time Frame: 6 months
The scale is an assessment of a person's ability to self-manage his/her pain, function and other symptoms. The self-efficacy function scale has 9 questions, each scored on a scale of 1-10, with a total minimum score of 10 and a maximum score of 90. The self-efficacy pain scale has 5 questions, with a total minimum score of 5 and a maximum score of 50. The self-efficacy other symptoms scale has 6 questions, with a minimum total score of 6 and a maximum score of 60. The other symptoms scale and the pain scale may be combined, with a sum score given.
6 months
Exercise Benefits/Barriers Scale (EBBS)
Time Frame: 6 months
Measuring the perceived benefits of and barriers to performing the prescribed exercises. There are 43 questions in total. It may be scored in it's entirety or as two separate scales. Scores can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. The benefits scale is scored between 29 and 116. The barriers scale is scored between 14 and 56. The higher the score on the barriers scale, the greater the perception of barriers to exercise. If combined, the barriers scale is reverse-scored.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. James's Hospital, Ireland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis
Salaso Health Solutions Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Finbar O'Shea, Consultant Rheumatologist, Saint James's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJH AS Salaso Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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