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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

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

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]

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]

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]

6 and 12 months after surgery

Primary outcome [2]

Olerud Molander Ankle Score (OMAS).

Timepoint [2]

6 and 12 months after surgery

Secondary outcome [1]

Muscle strength: number of heel rises

Timepoint [1]

6 and 12 months after surgery

Secondary outcome [2]

Ankle mobility in plantar flexion and dorsiflexion using a goniometer

Timepoint [2]

6 and 12 months after surgery

Secondary outcome [3]

Timed walking speed 30 m using a stop watch

Timepoint [3]

6 and 12 months after surgery

Secondary outcome [4]

Health Related Quality of Life (HQoL): Short Form 36 (SF-)36

Timepoint [4]

6 and 12 months after surgery

Eligibility

Key inclusion criteria

Surgically treated ankle fracture

Minimum age

18 Years

Maximum age

64 Years

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2003

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sweden

State/province [1]

Skane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Skane County Council, Primary Health Care

Address [1]

Baravagen 1, SE 221 00 Lund

Country [1]

Sweden

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Skane County Council

Address [2]

Region Skane, Baravagen 1, SE 221 00 Lund

Country [2]

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]

University

Name [1]

Lund University

Address [1]

Baravagen 3, SE 221 00 Lund

Country [1]

Sweden

Secondary sponsor category [2]

University

Name [2]

Lund University

Address [2]

Baravagen 3, SE 221 00 Lund

Country [2]

Sweden

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Lund University

Ethics committee address [1]

Barngatan 2, SE 221 85 Lund

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Gertrud Nilsson

Address

Ouvertyrvagen 2, SE 245 42 Staffanstorp

Country

Sweden

Phone

+ 46 70 673 52 94

Fax

gertrud.nilsson@med.lu.se

Contact person for scientific queries

Name

Gertrud Nilsson

Address

Ouvertyrvagen 2, SE 245 42 Staffanstorp

Country

Sweden

Phone

+ 46 70 673 52 94

Fax

gertrud.nilsson@med.lu.se

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial	2009	https://doi.org/10.1186/1471-2474-10-118

N.B. These documents automatically identified may not have been verified by the study sponsor.

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