AFTER – Ankle fracture treatment: enhancing rehabilitation trial
| ISRCTN | ISRCTN11830323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11830323 |
| IRAS number | 308989 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 308989, CPMS 52704 |
- Submission date
- 06/01/2022
- Registration date
- 03/05/2022
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
After a broken ankle, the lower leg is usually placed in a cast or boot for a number of weeks so the broken bone can heal. When the cast or boot is removed the ankle initially feels stiff and sore. At this time, patients are given advice by health professionals on how to gradually get back to their usual activities and are given exercises to do at home.
In some hospitals, patients are asked to attend physiotherapy sessions, whilst in other hospitals, patients will just receive advice. There is currently no scientific evidence showing that seeing a physiotherapist after an ankle fracture improves recovery. As physiotherapy appointments aren’t always convenient for patients, and because it’s important to make the best use of NHS time and resources, we want to find out if attending physiotherapy after an ankle fracture really does help improve recovery. This study aims to find out the best way to provide rehabilitation for people aged 50 and over who have a broken ankle.
Who can participate?
People aged 50 and over who have a broken ankle.
What does the study involve?
If patients are happy to take part in this study, a researcher will help them to complete a short online questionnaire that asks about the patient's health and level of activity, and ankle. This questionnaire should take no more than 10 minutes to complete.
Researchers will then use a computer program to allocate patients to one of the treatment groups. Patients will be randomised to either self-directed or supervised rehabilitation.
Self-directed rehabilitation involves the doctor, physiotherapist or nurse at the hospital providing advice and exercises to be followed at home. Patients will be provided with a detailed advice workbook and/or access to a website. The workbook and website contain a set of exercises that can be progressed independently over the next few months.
If patients are randomised to supervised rehabilitation they will receive the same advice and a workbook/access to a website. In addition, they will also attend 4-6 sessions with a physiotherapist to receive advise on exercises and progression. Sessions may be face-to-face or remotely by telephone/video call. The physiotherapy sessions will take place over three months.
All patients will then be asked to complete a further questionnaire at two, four and six months post randomisation.
What are the possible benefits and risks of participating?
Fully qualified, registered health professionals will provide treatment. They will use widely recognised treatments in the NHS. We hope the information from this study will be used to help treat people with broken ankles more effectively.
Patients are unlikely to be harmed by this treatment. They may experience soreness after completing some of the exercises. This is normal, and patients will be given advice on how to manage this soreness. We are not able to pay travel expenses for attendance at physiotherapy sessions as this part of patients treatment.
Where is the study run from?
The University of Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2021 to April 2025.
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr David Keene, after@ndorms.ox.ac.uk
Contact information
Scientific
Kadoorie Centre
Level 3
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-7249-6496 |
|---|---|
| Phone | +44 1865223126 |
| after@ndorms.ox.ac.uk |
Study information
| Study design | Multicentre randomized parallel-group superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40904 AFTER_PIS_V0.6_17Feb2022.pdf |
| Scientific title | Effectiveness of supervised versus self-directed rehabilitation for people aged 50 years and over with ankle fractures: the AFTER trial |
| Study acronym | AFTER |
| Study objectives | Our study will find out if referral for physiotherapy appointments after a person over 50 years has suffered a broken ankle helps them recover quicker and better when compared to good quality advice on self-management which includes booklets and videos. |
| Ethics approval(s) | Approved 12/05/2022, North West - Liverpool Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048118, +44 (0)2071048035, +44 (0)2071048016; liverpoolcentral.rec@hra.nhs.uk), ref: 22/NW/0131 |
| Health condition(s) or problem(s) studied | Ankle fracture |
| Intervention | Randomisation procedure Participants will be randomised by the local research team using a web-based service. Participants will be randomised at the stage they have weight bearing and movement restrictions outside of a cast or boot lifted at approximately 6 weeks (and no earlier than 4 weeks) after injury/surgery. The randomisation will be on a 1:1 basis to supervised versus self-directed rehabilitation. Supervised rehabilitation arm Participants randomised to supervised rehabilitation will receive an advice booklet available in paper or online format from the fracture clinic, it will contain key information on early recovery after removal of the cast/boot and basic initial exercises that they can start ahead of seeing a physiotherapist. They will be referred to see a physiotherapist, which is the most common current standard of care. Participants will have 4 to 6 one-to-one sessions with a physiotherapist, spread over 3 months from the initial session. The first session will be as soon as possible after the referral, and no later than three weeks from randomisation. Sessions will be delivered via face-to-face or telephone/videoconference, whichever mode of physiotherapy delivery would usually be provided for the patient. Exercise progression will be individualised by progressing and regressing the volume and load in line with each participant’s capabilities and preferences. Participants will be asked to identify their goals and, with the physiotherapist’s help, write an action plan for where and when they will perform their home exercises and a contingency plan for managing difficulties. Participants receive a personal exercise guide and diary. Self-directed Rehabilitation arm Participants randomised to Self-directed rehabilitation will receive an advice booklet available in paper or online format from the fracture clinic, it will contain standardised high-quality detailed advice on self-management and a set of exercises that can be progressed independently by the participant in the following months of recovery. The advice materials will be provided by a healthcare professional during the fracture clinic appointment. The advice will be accessible in paper format as well as online with additional instruction videos. Commonly used simple methods to support exercise adherence will be used, including goal setting and provision of an exercise diary. Participants will access this booklet/ website facility when they wish. Both arms Participants will receive an electronic/paper invite (according to the participant’s preference) to complete questionnaires. Reminders will be sent by email, post and/or text message. Any secure online link will be included in the email or text message so that participants can complete the questionnaires online. These questionnaires will be sent at 2, 4 and 6 months post randomisation |
| Intervention type | Other |
| Primary outcome measure | Ankle function measured by Olerud and Molander Ankle Scale (OMAS) at 6 months post randomisation |
| Secondary outcome measures | 1. Ankle function measured by Olerud and Molander Ankle Scale (OMAS) at baseline and 2 and 4 months post randomisation. 2. Health-related quality of life measured by EQ-5D-5L at Baseline, 2, 4 and 6 months post-randomisation. 3. Pain, measured by pain sub-scales of the EQ-5D-5L and OMAS at Baseline, 2, 4 and 6 months post-randomisation. 4. Physical Function, measured by PROMIS Physical Function at Baseline, 4 and 6 months post-randomisation. 5. Self-efficacy measured by Self-Efficacy Exercise Score at Baseline, 4 and 6 months post-randomisation 6. Participant exercise adherence, measured with self-reported exercise frequency at 2, 4 and 6 months post-randomisation. 7. Participant complications, measured with complications questionnaire and Case Report Form at 2, 4 and 6 months post-randomisation. 8. Cost effectiveness of interventions measured with health economics questionnaire at 2 and 6 months post-randomisation |
| Overall study start date | 01/09/2021 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 344 |
| Total final enrolment | 377 |
| Key inclusion criteria | 1. Patient is aged 50 years and over with an ankle fracture undergoing surgical fixation or nonsurgical management 2. Patient is provided with a cast or orthotic boot (non-removable or removable for non-weight bearing ankle movement) for at least 4 weeks and no longer than 10 weeks 3. Patient has capacity to consent to trial participation within 14 days of removal of the cast/boot |
| Key exclusion criteria | 1. Patient is deemed unable to adhere to trial procedures or complete questionnaires 2. Patient was not ambulatory before the injury 3. Patient has contraindications to participation in an exercise programme |
| Date of first enrolment | 15/09/2022 |
| Date of final enrolment | 15/11/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Bath
BA1 3NG
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Harlow
CM20 1QX
United Kingdom
London
SE5 9RS
United Kingdom
Steeton
Keighley
BD20 6TD
United Kingdom
Llangefni
LL77 7LT
United Kingdom
Sheffield
S5 7AU
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
North Shields
NE29 8NH
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Luton
LU4 0DZ
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Sponsor information
University/education
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the chief investigator, Dr David Keene, after@ndorms.ox.ac.uk, and will be assessed on a case-by-case basis |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 0.6 | 17/02/2022 | 21/02/2022 | No | Yes |
| Protocol file | version 0.5 | 17/02/2022 | 21/02/2022 | No | No |
| Participant information sheet | version 3.0 | 12/05/2022 | 16/09/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | design and delivery of the interventions | 24/03/2025 | 23/04/2025 | Yes | No |
Additional files
Editorial Notes
23/04/2025: Publication reference added.
31/01/2025: The following changes were made to the trial record:
1. The overall end date was changed from 31/10/2024 to 30/04/2025.
2. The intention to publish date was changed from 31/10/2024 to 31/07/2025.
3. The plain English summary was updated to reflect these changes.
23/07/2024: The following changes were made:
1. The overall study end date was changed from 31/07/2024 to 31/10/2024.
2 The intention to publish date was changed from 31/07/2024 to 31/10/2024.
3. The total final enrolment number was added.
4. The individual participant data (IPD) sharing plan and summary were added.
27/10/2023: The following trial participating centres were added: Royal Berkshire Hospital, Hampshire Hospitals NHS Foundation Trust, West Suffolk NHS Foundation Trust, Wrightington, Wigan and Leigh NHS Foundation Trust.
05/04/2023: The following trial participating centres were added: University Hospitals of Leicester NHS Trust, Royal Cornwall Hospitals NHS Trust, Northumbria Healthcare NHS Foundation Trust (headquarters), Milton Keynes General Hospital, Eastbourne Hospitals NHS Trust, South Tyneside and Sunderland NHS Foundation Trust, Luton and Dunstable University Hospital, William Harvey Hospital, North West Anglia NHS Foundation Trust, Victoria Hospital.
18/01/2023: Somerset NHS Foundation Trust, North Bristol NHS Trust, Royal Devon University Healthcare NHS Foundation Trust, The Princess Alexandra Hospital, King’s College Hospital NHS Foundation Trust, Airedale General Hospital, Betsi Cadwaladr University Lhb Anglesey Office, Northern General Hospital and Surrey and Sussex Healthcare NHS Trust have been added as trial participating centres.
16/09/2022: The following changes were made to the trial record:
1. Trial website added.
2. The recruitment start date was changed from 01/08/2022 to 15/09/2022.
3. The recruitment end date was changed from 01/09/2023 to 15/11/2023.
4. The following were added as trial participating centres: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Oxford University Hospitals, Pinderfields Hospitals NHS Trust, Nottingham University Hospitals NHS Trust - City Campus.
5. The participant information sheet has been uploaded.
15/06/2022: Ethics approval details added.
21/02/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
