CClinicalTrials.gg
Status unknownNCT03457285Updated Nov 7, 2018

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

An interventional study of Physiotherapy in Ankylosing Spondylitis, sponsored by St. James's Hospital, Ireland. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by St. James's Hospital, Ireland · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • Ankylosing spondylitis; physiotherapy; Salaso
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of Ankylosing Spondylitis

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • OtherPhysiotherapy

    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.

    Also known as: Salaso

05

What researchers measure

Primary outcomes

  1. Bath Ankylosing Spondylitis Metrology Index

    Measure of spinal mobility

    Time frame: 6 months

Secondary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index

    Measuring disease activity in AS

    Time frame: 6 months

  2. Bath Ankylosing Spondylitis Functional Index

    Measuring functional activity in AS

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Physiotherapy Department, Saint James's Hospital
    Dublin, Ireland
    • Ciarán Brennan, MSc, BSc · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03457285
Lead sponsor
St. James's Hospital, Ireland
Collaborators
Salaso Health Solutions Limited, Novartis
Responsible party
Ciaran Brennan (Senior Physiotherapist in Rheumatologuy, St. James's Hospital, Ireland) — Principal investigator
First posted
Mar 7, 2018
Start date
Oct 17, 2018
Primary completion
Apr 17, 2019 (estimated)
Completion
May 31, 2019 (estimated)
Last update
Nov 7, 2018

Study contacts

Ciaran Brennan
Contact
cbrennan2@stjames.ie
0035314162503
Mark McGowan
Contact
mmcgowan@tjames.ie
0035314162503
Finbar O'Shea
principal investigator · Consultant Rheumatologist, Saint James's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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