Feasibility of TRAK to support physio in anterior cruciate ligament rehabilitatio

Not Applicable

Completed

• Conditions: Rupture of the anterior cruciate ligament; Musculoskeletal Diseases

• Registration Number: ISRCTN55635910
• Lead Sponsor: Homerton University Hospital NHS Foundation Trust

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27919864 protocol (added 24/07/2019) 2021 Results article in https://doi.org/10.1136/bmjsem-2020-001002 (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-24
• Study Completion: 2020-06-30
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adults immediately post ACL reconstruction
2. Referred to a structured NHS rehabilitation programme
3. Be able to read and write English to engage with learning materials on TRAK
4. Be able to give written informed consent themselves
5. Have access to the internet at home or on their phone

Exclusion Criteria

1. Individuals with complex co-morbidities or surgeries such as multi-ligament reconstruction or fracture
2. Lack of internet or smart phone access
3. Unable to read and write English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment measured by number of eligible patients who consent to participate from 16/07/2018 until 31/03/2019, and submitted to baseline measures and randomisation<br>2. Retention measured by number of patients still in trial and consenting to outcomes at 3 and 6 months after recruitment date<br>3. Feasibility of collecting outcomes measured by collecting outcomes relevant for a future trial at baseline, 3 and 6 months<br>4. Feasibility of collecting strength outcome measured by submitting patient to leg symmetry testing at 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Usage of the intervention is measured by number of logins, number of pages visited and number of videos watched at 3 and 6 months<br>2. Knee function measured by KOOS (knee injury & osteoarthritis outcome score) at baseline, 3 months and 6 months<br>3. Health resource use measured by CSRI at baseline, 3 and 6 months<br>4. Self-efficacy measured by Stanford self-efficacy questionnaire at baseline, 3 and 6 months<br>5. Quality of life years calculated by EQ5D5L measured at baseline, 3 and 6 months<br>6. Health economic data collected by WPAI (work productivity and activity impairment questionnaire: general health) measured at baseline, 3 and 6 months