Early motion and directed exercise (EMADE) in ankle fracture fixation
| ISRCTN | ISRCTN11212729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11212729 |
| Secondary identifying numbers | 18892 |
- Submission date
- 13/03/2017
- Registration date
- 20/03/2017
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Ankle fractures are very common, comprising up to 20% of all leg fractures. The best type and timing of rehabilitation for this condition remains unclear. For those who need to have surgery to fix their ankle fracture it is normal for them to remain in a leg cast and not put the foot to the floor for 6-weeks. However, early exercise, outside of a cast, could be a viable option. The study team has created an Early Motion And Directed Exercise (EMADE) rehabilitation programme, which is designed to be used from the second to the sixth week after surgery. The aim of this study is to find out whether starting physiotherapy early using the EMADE programme can help patients who have had surgery to fix ankle factors recover more quickly and completely.
Who can participate?
Adults who have a fractured ankle which is being treated by surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are fitted with a light-weight below knee cast and remain non-weightbearing while walking until the six-week orthopaedic clinic review. Those in the second group are fitted with a removable cast that is retained with Velcro straps. They are also non-weightbearing during gait until the six-week orthopaedic clinic review. These participants take their cast off to conduct exercises several times per day at home. These exercises include bending the ankle towards them and pointing the ankle and toes down, and later strengthen with elastic exercise bands. During weekly one-to-one physiotherapy sessions (three, four and five weeks after surgery) the frequency and intensity are progressed on an individual basis. Hands-on treatments and education on the condition and responses to exercise are also provided. From the six-week orthopaedic review, it is common for the cast to be removed and if the X-ray is satisfactory, participants in both groups can then start taking weight on the ankle while walking. Participants complete questionnaires about their symptoms and function at the start of the study and at six, 12, 24 and 52 weeks following their surgery.
What are the possible benefits and risks of participating?
There is no guarantee of direct benefits however the information gained may contribute to improving treatment for ankle fractures in the future. There are no notable risks involved with participating.
Where is the study run from?
Queen's Medical Centre (UK)
When is the study starting and how long is it expected to run for?
November 2011 to December 2018
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
1. Miss Jess Nightingale (public)
jessica.nightingale@nuh.nhs.uk
2. Mr Benhamin Ollivere (scientific)
Benjamin.Ollivere@nottingham.ac.uk
Contact information
Public
Trauma and Orthopaedics
C Floor, West Block, QMC
Nottingham University Hospitals
Derby Road
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 (ext. 67502) |
|---|---|
| jessica.nightingale@nuh.nhs.uk |
Scientific
Academic Orthopaedics, Trauma and Sports Medicine
University of Nottingham
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0002-1410-1756 |
|---|---|
| Phone | +44 (0)115 82 31115 |
| Benjamin.Ollivere@nottingham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN11212729_PIS_04Nov16_V2.1.pdf |
| Scientific title | Early motion and directed exercise (EMADE) post ankle fracture fixation: a pragmatic randomised controlled trial |
| Study acronym | EMADE |
| Study objectives | Early motion and directed exercise (EMADE) physiotherapy will perform better than usual care at three months following operative fixation of a Weber B fracture as measured by the Oleurd and Molander Score (OMAS). |
| Ethics approval(s) | NRES Committee East Midlands – Nottingham 2, 04/11/2014, ref: 14/EM/1213 |
| Health condition(s) or problem(s) studied | Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies |
| Intervention | Participants receive identical care pre-operatively and in the first two post-operative weeks consisting of admission to hospital, consultant supervised surgery including management on a standard care pathway. Participants are discharged home in a plaster cast and reviewed two weeks following surgery. All participants undergo x-ray and wound inspection following plaster removal at the two week review. All participants are non-weightbearing throughout the study until the six week point. Participants in the intervention group at two weeks fitted with a removable cast (3M Delta-cast soft cast, with an integrated focussed rigid back-slab casting and Velcro retaining straps). At the two-week review a focussed physiotherapy exercise programme commences up to six times a day. The range-of-motion and strengthening home exercise programme is taught during weekly face to face sessions (weeks three, four and five post-surgery) and progressed as appropriate. To encourage compliance with the EMADE home exercise programme, written and pictorial instructions are provided. During sessions manual therapy and education is provided as per protocol. Participants in the usual care group are treated in a plaster until the six week point. From the six-week review all study participants receive the same standard care. This includes removal of casts and if appropriate on X-ray review, commencement of weight bearing as tolerated, and physiotherapy as required. Protocol deviations, as per standard care, are based on individual clinical decision, for example removal of metal work, including syndesmosis screws. |
| Intervention type | Other |
| Primary outcome measure | Symptoms and function, are measured by the Olerud and Molander ankle score (OMAS) patient reported outcome measure (PROM), recorded at 2 and 6-weeks post-surgery, as baseline and end-of-intervention respectively and at 12 (Primary timepoint) 24 and 52-weeks post-surgery. |
| Secondary outcome measures | 1. Symptoms and function, are measured using the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) PROM and use of walking aids at; 2, 6, 12, 24 and 52-weeks post-surgery 2. Generic quality of life is measurers using the EuroQoL EQ-5D-5L and level of activity PROMs at; 2, 6, 12, 24 and 52-weeks post-surgery 3. Health and social economic impact, are measured by ability and time to return to work and return to driving (where applicable), ankle related hospital attendance, quality adjusted life years (derived from the EQ-5D-5L), and complication rates are recorded through reviewing routine X-rays, hospital attendance and adverse events at; 2, 6, 12, 24 and 52-weeks post-surgery 4. Objective Ankle function is measured by non-weightbearing range-of-motion (dorsiflexion and plantar flexion) and tape measured ankle and calf sizes at; 2 and 6weeks post-surgery. Objective Ankle function measures are repeated with the addition of weightbearing dorsiflexion, walking speed, balance and isokinetic planter flexion strength at; 12, 24 and 52-weeks post-surgery To mitigate against bias, participants complete the 12-, 24- and 52-week PROMs, concealed from the researchers. A third party, blinded to the intervention group inputs the data, and analysis of the PROMs is completed by a Statistician, who is also blinded to the intervention group. |
| Overall study start date | 01/11/2011 |
| Completion date | 20/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 156 |
| Total final enrolment | 157 |
| Key inclusion criteria | 1. Aged 18 and over 2. Independently living 3. Isolated and closed Weber B ankle fractures which are stable following internally fixation |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Diabetes 3. Non-healing leg/foot ulcers 4. Steroid users 5. Pre-existing ankle arthritis and concurrent or history of significant ipsilateral or contralateral lower limb injury/condition e.g. contralateral leg prosthesis 6. Neurological disorders |
| Date of first enrolment | 11/06/2015 |
| Date of final enrolment | 19/06/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Trauma and Orthopaedics
C Floor
West Block
Derby Road
Nottingham
NG7 2UH
United Kingdom
Mansfield Road
Sutton in Ashfield
NG17 4JL
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/05y3qh794 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publications will include a final report and presentations at scientific conferences and meetings, with the overall results published in high-impact peer reviewed journal, approximately one year after the overall trial end date. Additional dissemination may include patient/public participation seminars and meetings, such as those organised by Arthritis Research UK. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.1 | 04/11/2016 | 23/03/2017 | No | Yes |
| Protocol article | protocol | 31/05/2018 | Yes | No | |
| Results article | 01/05/2020 | 18/02/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN11212729_PIS_04Nov16_V2.1.pdf
- Uploaded 23/03/2017
Editorial Notes
18/02/2022: Publication reference added.
03/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2017 to 19/06/2018.
2. The overall end date was changed from 31/12/2018 to 20/06/2019.
3. The total final enrolment was added.
06/07/2018: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2017 to 07/07/2018
2. The target number of participants was changed from 144 to 156
3. The total target enrolment was changed from 144 to 156
4. The address of the trial participating centre Queen's Medical Centre was changed
5. King's Mill Hospital and Oxford University Hospital NHS Foundation Trust were added as trial participating centres
04/06/2018: Publication reference added.
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
