Trial from ANZCTR


Trial ID ACTRN12609000766213
Trial Status: Registered
Date Submitted: 5/07/2009
Date Registered: 3/09/2009
Retrospectively registered

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Public title An investigation of balance, muscle activation patterns and gait after total hip or knee replacement surgery.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format In people who have undergone total hip or knee replacement, does aquatic physiotherapy enhance the recovery of balance, muscle activation patterns and gait parameters more than water exercise or additional ward physiotherapy?
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Hip or knee arthroplasty 237163 0
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Physical Medicine / Rehabilitation Physiotherapy
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237486 237486 0 0
Musculoskeletal Other muscular and skeletal disorders
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Descriptions of intervention(s) / exposure A sub-group of participants in a randomised controlled trial (RCT) investigating the efficacy of inpatient aquatic physiotherapy after total hip or knee replacement surgery participated in this study (ACTRN12608000354381: "Does a specific inpatient aquatic physiotherapy program after joint replacement surgery improve strength more than additional ward physiotherapy or water exercise?"). They underwent additional laboratory investigations of muscle activation, balance and computerised gait analysis. Participants from each of the three intervention groups of the RCT were required and two different tasks were to be measured in the laboratory.
In the first, subjects are required to perform a stepping task whilst standing on force platforms and with surface electromyography (EMG) electrodes placed over 5 muscles to record muscle activation. Surface electrodes are applied to the skin overlying tensor fascia latae (TFL) bilaterally and on the gluteus medius, vastus lateralis (VL), vastus medialis (VM) of the stance leg. A ground electrode will be placed over the fibula head. The electrodes are connected to a lightweight hip pack, which is connected to an amplifier and then to an A-D board which records and displays the muscle activity in real time. Placement will be verified by the recording of a sub-maximal contraction: hip abduction in standing with the hip in neutral rotation and toes lifted 5cm from ground (TFL and gluteus medius) and knee extension (VL and VM). Subjects stand with each foot on a force platform (10cm between medial malleoli), with a 15cm high step placed 10cm in front of the toes. Tones will be played through a computer, with a high tone (5kHz) indicating to begin stepping. Two conditions will be measured. Subjects will be asked to step as quickly as possible when they hear the first tone (10 repetitions). In the second condition, subjects are required to lift their foot off at the first tone ,and land their foot on the step in time with the second tone. Subjects are measured stepping with both legs, so a total of forty steps are recorded - 10 fast and then slow steps standing on the operated leg and then 10 fast and slow steps stepping with the operated leg.
The second task is for subjects to walk along a computerised walkway , completing three trials at a comfortable pace and three at a pace that is 'as fast as you safely can'.
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Intervention Code:
Rehabilitation 236874 0
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Comparator / control treatment A group of healthy community-dwelling elders were also recruited and assessed once using the same laboratory and clinical measures from the randomised controlled trial to provide normative age-matched data for comparison.
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Control group Active
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Primary Outcome: muscle onset time of gluteus medius and tensor fascia lata relative to prime mover measured during stepping task using electromyography (EMG) 238293 0
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Timepoint: pre-operative, then day 14, day 90 and day 180 post-operatively 238293 0
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Primary Outcome: reaction time and step time measured with the forceplate during stepping task 238294 0
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Timepoint: pre-operative, then day 14, day 90 and day 180 post-operatively 238294 0
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Primary Outcome: single support time and step length measured with computerised gait system 238295 0
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Timepoint: pre-operative, then day 14, day 90 and day 180 post-operatively 238295 0
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Secondary Outcome: muscle onset time of vastus medialis and vastus lateralis measured relative to prime mover for stepping, using EMG recorded during stepping task 244671 0
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Timepoint: pre-operative, then day 14, day 90 and day 180 post-operatively 244671 0
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Secondary Outcome: gait velocity measured using the computerised gait system 244672 0
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Timepoint: pre-operative, then day 14, day 90 and day 180 post-operatively 244672 0
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Key inclusion criteria subgroup from RCT:
- be booked for total hip replacement (THR) or total knee replacement (TKR) surgery and already given consent to take part in the randomised controlled trial
- able to travel to research laboratory before and after surgery
healthy community-dwelling elders
- no musclo-skeletal or neurological conditions that effect mobility or balance
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Minimum age 50 Years
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Maximum age 80 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria - insufficient time before hospital admission to attend research laboratory for pre-op assessment
- live too far from research laboratory so travel to laboratory day 14 after surgery not possible
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Nonrandomised trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) This sub-study required volunteers from each of the three intervention groups of the larger RCT that was already underway who were willing and able to make their way the gait laboratory both before and after hospital stay.(ACTRN12608000354381: "Does a specific inpatient aquatic physiotherapy program after joint replacement surgery improve strength more than additional ward physiotherapy or water exercise?").
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) subjects were not randomised in this sub-study
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features The primary researcher identified potential participants for this sub-study from those who had agreed to take part in the main RCT, ensuring representation from both types of surgery and each of the three intervention groups.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/04/2005
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 20
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 237264 0
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Name: The Wesley Research Institute 237264 0
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Address: Level B2
Moorlands Wing
The Wesley Hospital
451 Coronation Drive
Auchenflower
Queensland
4066
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Country: Australia 237264 0
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Primary Sponsor University
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Name: The University of Queensland
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Address: Division of Physiotherapy
The University of Queensland
St Lucia
Queensland
4072
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Country: Australia
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Secondary Sponsor: None 236749 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The University of Queensland Medical Ethics Committee 239366 0
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Address: Cumbrae Stewart Building
Research Road
St Lucia
Queensland
4072
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Country: Australia 239366 0
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Approval Date: 07/11/2002 239366 0
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Submitted Date: 239366 0
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HREC: 2002000723 239366 0
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Brief summary This study firstly aims to determine if there are differences in the post-operative recovery in terms of muscle activation, lower limb strength and balance between people who have had additional aquatic physiotherapy and those who have had standard ward treatment. The second aim is to determine if there is a relationship between the laboratory measures of muscle activation, with clinical measures of strength and function. The third is to compare the muscle activation patterns and timing at various stages of recovery of those who have had surgery with those of healthy older people. We hypothesise that, people undergoing total hip or knee replacement will demonstrate a delay in timing of muscle activation in a step task and greater variation in gait parameters in comparison to healthy elders; those who have not had additional inpatient aquatic physiotherapy after THR or TKR will demonstrate a delay in timing of muscle activation in a step task and greater variation in gait parameters than those who had aquatic physiotherapy; and there will be a positive correlation between a delay in muscle timing and reduced clinical measures of strength and function.
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Principal Investigator
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Contact person for public queries
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Name: Ann Rahmann
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Address: Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland St Lucia Queensland 4072
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Country: Australia
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Tel: +61 7 3365 2275
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Fax: +61 7 3365 1622
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Email: a.rahmann@uq.edu.au
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Contact person for scientific queries
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Name: Ann Rahmann
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Address: Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland St Lucia Queensland 4072
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Country: Australia
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Contact person responsible for updating information
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Name: Ann Rahmann
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Address: Division of Physiotherapy School of Health and Rehabilitation Sciences The University of Queensland St Lucia Queensland 4072
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Country: Australia
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Addition Cancer fields
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