NCT03457285

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

February 1, 2018

Last Update Submit

November 6, 2018

Conditions

Keywords

Ankylosing spondylitis; physiotherapy; Salaso

Outcome Measures

Primary Outcomes (1)

  • Bath Ankylosing Spondylitis Metrology Index

    Measure of spinal mobility

    6 months

Secondary Outcomes (4)

  • Bath Ankylosing Spondylitis Disease Activity Index

    6 months

  • Bath Ankylosing Spondylitis Functional Index

    6 months

  • Arthritis Self-Efficacy Scale (ASES)

    6 months

  • Exercise Benefits/Barriers Scale (EBBS)

    6 months

Study Arms (1)

Physiotherapy via the Salaso Apllication Intervention

EXPERIMENTAL

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

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
Physiotherapy via the Salaso Apllication Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Ankylosing Spondylitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department, Saint James's Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Finbar O'Shea

    Consultant Rheumatologist, Saint James's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking will take place
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the same intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist in Rheumatologuy

Study Record Dates

First Submitted

February 1, 2018

First Posted

March 7, 2018

Study Start

October 17, 2018

Primary Completion

April 17, 2019

Study Completion

May 31, 2019

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations