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Trial registered on ANZCTR


Registration number
ACTRN12609000327280
Ethics application status
Approved
Date submitted
5/05/2009
Date registered
22/05/2009
Date last updated
22/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a neuromuscular training program on pain and function after surgically treated ankle fracture. A prospective randomised controlled trial
Scientific title
Effects of a neuromuscular training program on pain and function after surgically treated ankle fracture. A prospective randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgically treated ankle fractures 4743 0
Condition category
Condition code
Injuries and Accidents 237048 237048 0 0
Fractures
Musculoskeletal 237077 237077 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A neuromuscular training program, that started within one week after plaster removal and continued for 8-12 weeks. The patient trained at the nearby physiotherapist in the primary care two times per week. The duration of each session was one hour and between the sessions home exercises relevant at the moment had to be performed. The home exercises had to be performed every day except the day when training was performed at the phyiotherapist. The type of exercises varied during the rehabilitation process and the phyiotherapist had to determine what type, number that should be perofmred and frequence during tha day. For example strengt training could be 15 x 3 while stretching could be performed 30 sec x 3. That is the home exercises varied on case by case. Mobility exercises, strengt training, stretching and functional execises like different type of walking exercises, jumping and so on were peroformed. The physiotherapists were carefully informed that the training had to be on a level that not increased swelling or pain.
Intervention code [1] 4493 0
Rehabilitation
Comparator / control treatment
Usual care: Patients followed the principles that are normally applied at the orthopaedic clinic from where the patients were recruited. That is after 6-8 weeks when plaster cast is removed the doctor examined the ankle and depending on the status and doctor's opinion the patient could be referred to a physiotherapist or encourraged to start walking and resume function on their own as soon as possible. The neuromuscular training program applied in the intervention group was kept apart from other physiothrapists than those included in the intervention study. The physiotherapists in the "usual care" group had to apply the methods that normally are used. The duration, methods used and choice of exercises varied on case by case and was determined by the physiotherapist. Also the time after plaster removal when the training started varied on case by case.
Control group
Active

Outcomes
Primary outcome [1] 5886 0
Olerud Molander Ankle Score (OMAS). Nine items are included measuring 1) ankle pain, 2)ankle stiffness, 3) ankle swelling; 4) stair-climbing, 5) running, 6) squatting 7) jumping, 8) need of walking aid, 8) working ability
Timepoint [1] 5886 0
6 and 12 months after surgery
Primary outcome [2] 5914 0
Olerud Molander Ankle Score (OMAS).
Timepoint [2] 5914 0
6 and 12 months after surgery
Secondary outcome [1] 241918 0
Muscle strength: number of heel rises
Timepoint [1] 241918 0
6 and 12 months after surgery
Secondary outcome [2] 241969 0
Ankle mobility in plantar flexion and dorsiflexion using a goniometer
Timepoint [2] 241969 0
6 and 12 months after surgery
Secondary outcome [3] 241970 0
Timed walking speed 30 m using a stop watch
Timepoint [3] 241970 0
6 and 12 months after surgery
Secondary outcome [4] 241973 0
Health Related Quality of Life (HQoL): Short Form 36 (SF-)36
Timepoint [4] 241973 0
6 and 12 months after surgery

Eligibility
Key inclusion criteria
Surgically treated ankle fracture
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
co-existing fractures, psychiatric diagnosis, drug abuse, symptom giving osteoarthritis in the lower extremity, systemic diseases, delayed surgery due to complications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1751 0
Sweden
State/province [1] 1751 0
Skane

Funding & Sponsors
Funding source category [1] 4902 0
Charities/Societies/Foundations
Name [1] 4902 0
Skane County Council, Primary Health Care
Address [1] 4902 0
Baravagen 1, SE 221 00 Lund
Country [1] 4902 0
Sweden
Funding source category [2] 4923 0
Charities/Societies/Foundations
Name [2] 4923 0
Skane County Council
Address [2] 4923 0
Region Skane, Baravagen 1, SE 221 00 Lund
Country [2] 4923 0
Sweden
Primary sponsor type
Charities/Societies/Foundations
Name
Skane County Council, Primary Health Care
Address
Baravagen 1, SE 221 00 Lund
Country
Sweden
Secondary sponsor category [1] 4434 0
University
Name [1] 4434 0
Lund University
Address [1] 4434 0
Baravagen 3, SE 221 00 Lund
Country [1] 4434 0
Sweden
Secondary sponsor category [2] 4451 0
University
Name [2] 4451 0
Lund University
Address [2] 4451 0
Baravagen 3, SE 221 00 Lund
Country [2] 4451 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6997 0
Ethics Committee of Lund University
Ethics committee address [1] 6997 0
Barngatan 2, SE 221 85 Lund
Ethics committee country [1] 6997 0
Sweden
Date submitted for ethics approval [1] 6997 0
Approval date [1] 6997 0
Ethics approval number [1] 6997 0

Summary
Brief summary
Purpose The aim of this study was to determinate the effects of a 12- week standardised but individually suited training program (training group) versus usual care (control group) after plaster removal in adults with surgically treated ankle fractures.

Methods In total, 110 men and women, 18-64 years of age, with surgically treated ankle fracture were included and randomised to either a 12-week training program or to a control group. Six and twelve months after the injury the subjects were examined by the same physiotherapist Gertrud Nilsson (GN), blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS) measuring symptoms and subjectively scored function. Secondary outcome measures were: quality of life (SF-36), timed walking tests, ankle mobility tests, muscle strength tests and radiological status.

Results 52 patients were randomised to the training group and 58 to the control group. Five patients dropped out before the six-month follow-up resulting in 50 patients in the training group and 55 in the control group. Nine patients dropped out between the six- and twelve-month follow-up resulting in 48 patients in both groups. When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects less than 40 years of age regarding OMAS (p=0.028), muscle strength in the plantar flexors (p=0.029) and dorsiflexors (p=0.030).

Conclusion The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study based on neuromuscular training principles was superior to usual care in patients under the age of 40. There is need for further studies to elucidate how a training program should be composed to increase and optimise function in patients middle-aged or older.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29572 0
Address 29572 0
Country 29572 0
Phone 29572 0
Fax 29572 0
Email 29572 0
Contact person for public queries
Name 12819 0
Gertrud Nilsson
Address 12819 0
Ouvertyrvagen 2, SE 245 42 Staffanstorp
Country 12819 0
Sweden
Phone 12819 0
+ 46 70 673 52 94
Fax 12819 0
Email 12819 0
gertrud.nilsson@med.lu.se
Contact person for scientific queries
Name 3747 0
Gertrud Nilsson
Address 3747 0
Ouvertyrvagen 2, SE 245 42 Staffanstorp
Country 3747 0
Sweden
Phone 3747 0
+ 46 70 673 52 94
Fax 3747 0
Email 3747 0
gertrud.nilsson@med.lu.se

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary