Dataset Information

Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial.

ABSTRACT:

Background

Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate 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 who was blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS) which rates 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 younger 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 was superior to usual care in patients under the age of 40. However, as only three out of nine outcome measures showed a difference, the beneficial effect from an additional standardised individually suited training program can be expected to be limited. There is need for further studies to elucidate how a training program should be designed to increase and optimise function in patients middle-aged or older.

Trial registration

Current Controlled Trials ACTRN12609000327280.

SUBMITTER: Nilsson GM

PROVIDER: S-EPMC2760502 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Publications

Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial.

Nilsson Gertrud M GM Jonsson Kjell K Ekdahl Charlotte S CS Eneroth Magnus M

BMC musculoskeletal disorders 20090925

<h4>Background</h4>Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate 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.<h4>Methods</h4>In total, 110 men and women, 18-64 years of ...[more]

PMID: 19781053

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Project description:BackgroundPostoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.MethodsA pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 h versus non-weight-bearing (NWB) and immobilisation in a cast for 6 weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.DiscussionTraditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registrationISRCTN Registry ISRCTN76410775 . Retrospectively registered on 30 June 2019.

Project description:BackgroundEvidence implementation continues to challenge health professionals most especially those from developing countries. Filipino physiotherapists represent a group of health professionals in a developing country who by tradition and historical practice, take direction from a doctor, on treatment options. Lack of autonomy in decision-making challenges their capacity to deliver evidence-based care. However, this scenario should not limit them from updating and up-skilling themselves on evidence- based practice (EBP). EBP training tailored to their needs and practice was developed to address this gap. This study will be conducted to assess the effectiveness of a tailored EBP-training program for Filipino physiotherapists, in improving knowledge, skills, attitudes and behaviour to EBP. Participation in this program aims to improve capacity to EBP and engage with referring doctors to determine the most effective treatments for their patients.Methods/designA double blind randomised controlled trial, assessing the effectiveness of the EBP training intervention, compared with a waitlist control, will be conducted. An adequately powered sample of 54 physiotherapists from the Philippines will be recruited and randomly allocated to EBP intervention or waitlist control.InterventionThe EBP program for Filipino physiotherapists is a one-day program on EBP principles and techniques, delivered using effective adult education strategies. It consists of lectures and practical workshops. A novel component in this program is the specially-developed recommendation form, which participants can use after completing their training, to assist them to negotiate with referring doctors regarding evidence-based treatment choices for their patients.Pre and post measures of EBP knowledge, skills and attitudes will be assessed in both groups using the Adapted Fresno Test and the Questions to EBP attitudes. Behaviour to EBP will be measured using activity diaries for a period of three months.DiscussionShould the EBP-training program be found to be effective in improving EBP-uptake in Filipino physiotherapists, it will form the basis of a much needed national intervention which is contextually appropriate to Filipino physiotherapists. It will therefore form the genesis for a model for building EBP capacity of other health professionals in the Philippines as well as physiotherapists in developing countries.Trial registrationCurrent Controlled Trials: ISRCTN74485061.

Project description:Aim: The aim of this study was to assess the effect of home orthostatic training (HOT) on autonomic reflexes in elderly patients with vasovagal syncope (VVS). Methods: Design and Setting: A single-blind randomised control trial was conducted at Eastbourne District General Hospital, East Sussex NHS Trust. Patients: Individuals with recurrent syncope underwent tilt-table testing between August 2007 and October 2009.Those with at least two syncopal episodes and tilt-test proven VVS were recruited. Participants were divided into those aged >65 years (O65) and those aged <65 years (U65). Interventions: Patients in the O65 group were randomised 1:1 to receive active HOT (O65+) or sham HOT (O65-). The U65 group received active HOT. Participants performed HOT/sham HOT and recorded their training and symptoms. Patients had a repeat tilt test at 3 months. Outcome Measures: Time to syncope at repeat tilt-table testing, low-frequency heart rate variability (LF-HRV), high-frequency heart rate variability (HF-HRV), mean upslope baroreflex sensitivity (BRS) and mean downslope BRS were assessed. Results: A total of 106 patients with recurrent syncope underwent tilt-table testing. Of these, 45 consecutive patients (30 in the O65 group and 15 in the U65 group) were recruited. Two, one and three patients withdrew or were lost-to-follow-up in the O65+, O65-, and U65 groups, respectively. Symptomatic benefit occurred in four (31 %) of the O65+, four (29 %) of the O65-, and six (50 %) of the U65. None of the autonomic measures changed significantly in any group. No difference was seen with HF-HRV, LF-HRV mean upslope BRS and mean downslope BRS. Fifty per-cent of the O65+ group stopped training because of back pain. Time constraint (25 %) was the most common reason for cessation in the U65 group. Conclusions: Despite good tilt training compliance, no improvement in autonomic measures in any group was shown. The most common reason for cessation of training was back pain in the elderly groups. This study does not support the use of HOT in elderly patients.

Project description:BACKGROUND:Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. METHOD/DESIGN:We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. DISCUSSION:The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. TRIAL REGISTRATION:ISRCTN, ID: ISRCTN11212729 . Registered retrospectively on 20 March 2017.

Dataset Information

Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial.

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