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

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: Unknown
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Other: Physiotherapy

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Bath Ankylosing Spondylitis Metrology Index	Measure of spinal mobility	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bath Ankylosing Spondylitis Disease Activity Index	Measuring disease activity in AS	6 months
Bath Ankylosing Spondylitis Functional Index	Measuring functional activity in AS	6 months
Arthritis Self-Efficacy Scale (ASES)	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)	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

• Sponsor: St. James's Hospital, Ireland
• Collaborators: Novartis; Salaso Health Solutions Limited
• Investigators: Principal Investigator: Finbar O'Shea, Consultant Rheumatologist, Saint James's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2018
• Primary Completion (ANTICIPATED): April 17, 2019
• Study Completion (ANTICIPATED): May 31, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Ankylosing spondylitis; physiotherapy; Salaso
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID 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