Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000766213
Ethics application status
Approved
Date submitted
5/07/2009
Date registered
3/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of balance, muscle activation patterns and gait after total hip or knee replacement surgery.
Scientific title
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?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip or knee arthroplasty 237163 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237486 237486 0 0
Physiotherapy
Musculoskeletal 239925 239925 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description 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'.
Intervention code [1] 236874 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 238293 0
muscle onset time of gluteus medius and tensor fascia lata relative to prime mover measured during stepping task using electromyography (EMG)
Timepoint [1] 238293 0
pre-operative, then day 14, day 90 and day 180 post-operatively
Primary outcome [2] 238294 0
reaction time and step time measured with the forceplate during stepping task
Timepoint [2] 238294 0
pre-operative, then day 14, day 90 and day 180 post-operatively
Primary outcome [3] 238295 0
single support time and step length measured with computerised gait system
Timepoint [3] 238295 0
pre-operative, then day 14, day 90 and day 180 post-operatively
Secondary outcome [1] 244671 0
muscle onset time of vastus medialis and vastus lateralis measured relative to prime mover for stepping, using EMG recorded during stepping task
Timepoint [1] 244671 0
pre-operative, then day 14, day 90 and day 180 post-operatively
Secondary outcome [2] 244672 0
gait velocity measured using the computerised gait system
Timepoint [2] 244672 0
pre-operative, then day 14, day 90 and day 180 post-operatively

Eligibility
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
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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?").
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
subjects were not randomised in this sub-study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237264 0
Charities/Societies/Foundations
Name [1] 237264 0
The Wesley Research Institute
Country [1] 237264 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Division of Physiotherapy
The University of Queensland
St Lucia
Queensland
4072
Country
Australia
Secondary sponsor category [1] 236749 0
None
Name [1] 236749 0
Address [1] 236749 0
Country [1] 236749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239366 0
The University of Queensland Medical Ethics Committee
Ethics committee address [1] 239366 0
Cumbrae Stewart Building
Research Road
St Lucia
Queensland
4072
Ethics committee country [1] 239366 0
Australia
Date submitted for ethics approval [1] 239366 0
Approval date [1] 239366 0
07/11/2002
Ethics approval number [1] 239366 0
2002000723

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29849 0
Address 29849 0
Country 29849 0
Phone 29849 0
Fax 29849 0
Email 29849 0
Contact person for public queries
Name 13096 0
Ann Rahmann
Address 13096 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland
4072
Country 13096 0
Australia
Phone 13096 0
+61 7 3365 2275
Fax 13096 0
+61 7 3365 1622
Email 13096 0
[email protected]
Contact person for scientific queries
Name 4024 0
Ann Rahmann
Address 4024 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland
4072
Country 4024 0
Australia
Phone 4024 0
+61 7 3365 2275
Fax 4024 0
+61 7 3365 1622
Email 4024 0
[email protected]

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

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