K Study of tendo Achilles Rehabilitatio

Not Applicable

Completed

• Conditions: Achilles tendon rupture; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN62639639
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29070643 protocol (added 03/06/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32035553 results (added 10/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32068531/ (added 10/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-22
• Study Completion: 2019-05-31
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Patients will be considered for participation in this study if:
1. They are aged 16 years or older
2. They have a primary rupture of the Achilles tendon
3. They have decided to have non-operative treatment

Exclusion Criteria

Patients will be excluded from participation in this study if they:
1. Present to the treating hospital more than 14 days after the injury
2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires; for example, a history of permanent cognitive impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for this study is the Achilles tendon Total Rupture Score (ATRS). The ATRS is a validated questionnaire which is self-reported (filled out by the patient). It consists of 10 items assessing symptoms and physical activity specifically related to the Achilles tendon. It measures: strength, fatigue, stiffness, pain, activities of daily living, walking on uneven surfaces, walking upstairs or uphill, running, jumping and physical labour. This data will be collected at baseline, 3, 6 and 9 months post-injury.

Secondary Outcome Measures

Name	Time	Method
1. EQ-5D; The EQ-5D-5L is a validated, generic health-related quality of life measure consisting of 5 dimensions each with a 5-level answer possibility. <br>2. Complications; all complications will be recorded, from the medical records at the 8-week review and self-reported by the patient thereafter, including: re-rupture, blood clots/emboli, pressure areas/hindfoot pain, falls and neurological symptoms in the foot.