NCT05676632

Brief Summary

This project will assess the clinical outcomes of individuals completing rehabilitation for their Achilles tendon rupture at the University Hospitals of Leicester. Patients attending the Achilles tendon rupture clinic or rehabilitation classes will be asked to complete ultrasound imaging, strength testing and questionnaires. This will provide an insight into the rehabilitation outcomes of a broad range of patients at each rehabilitation timepoint.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

January 9, 2023

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 10, 2022

Last Update Submit

January 4, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    Week 0

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    week 8

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    week 10

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    4 months

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    6 months

  • Ultrasound Tissue Characterisation

    Imaging of the Achilles Tendon

    12 months

Secondary Outcomes (11)

  • Isometric plantarflexor strength testing

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Heel Raise Test

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Achilles Tendon Rupture Score (ATRS)

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • Tampa Scale of Kinesiophobia (TSK)

    Week 0, week 8, week 10, 4 months, 6 months and 12 months

  • +6 more secondary outcomes

Interventions

All participants attending the Achilles Tendon Rupture clinic will receive usual clinical care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals attending the Achilles tendon rupture clinic following Achilles tendon rupture

You may qualify if:

  • Able to provide informed consent
  • years of age or above

You may not qualify if:

  • Inability to provide informed consent due to cognitive impairment
  • Inability to provide informed consent as unable to understand sufficient English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Briggs-Price S, Yates T, Mangwani J, Bhatia M, Jones A, Mielcarek K, Solaini A, Leung SY, Gravare Silbernagel K, Hebert-Losier K, de Vos RJ, Millar NL, Vicenzino B, O'Neill S. Structure and function of the Achilles tendon and plantarflexors after non-surgical management of Achilles tendon rupture: A cross-sectional study. Musculoskelet Sci Pract. 2026 Feb;81:103459. doi: 10.1016/j.msksp.2025.103459. Epub 2025 Nov 25.

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

January 9, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

January 9, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share