Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000601033
Ethics application status
Approved
Date submitted
20/07/2010
Date registered
26/07/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of adding neuromuscular electrical stimulation to standard inpatient rehabilitation on quadriceps strength and physical function in individuals with total knee replacement
Scientific title
The effects of adding neuromuscular electrical stimulation to standard inpatient rehabilitation on quadriceps strength and physical function in individuals with total knee replacement: a randomized clinical study
Secondary ID [1] 252250 0
None
Universal Trial Number (UTN)
Trial acronym
Modifying Acute Rehabilitation of Knee Strength with Muscle and Nerve stimulation (MARKSMAN)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impairments in quadriceps muscle performance following total knee replacement 257769 0
Condition category
Condition code
Musculoskeletal 257944 257944 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 257945 257945 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard total knee replacement (TKR) rehabilitation with neuromuscular electrical stimulation (NMES) would be delivered separately by experienced Physiotherapists. Standard TKR rehabilitation would be delivered daily from the first day post surgery till the day of discharge. One day post surgery, NMES would be delivered daily for 4 consecutive days. Standard TKR rehabilitation comprises ambulatory, knee mobility, and knee strengthening exercises. For NMES, a portable unit will be used to deliver the electrical stimulation, and 2 pairs of self-adhesive surface electrodes will be placed over the vastus lateralis and vastus medialis muscles of the affected (operated) limb. The NMES unit will be set to deliver a 40-Hz biphasic current (450 microseconds pulse duration) for 5 seconds followed by a 20-second resting period (i.e., 20% duty cycle). During each 15-minute NMES session, a total of 30 repetitions will be performed, and the stimulation intensity will be adjusted to the maximal intensity tolerated by the patients.
Intervention code [1] 256830 0
Rehabilitation
Intervention code [2] 256831 0
Treatment: Devices
Comparator / control treatment
Patients who are randomized to the standard TKR rehabilitation without NMES group will receive standard TKR rehabilitation plus an active control treatment which comprises one set of 30 "static" (isometric) quadriceps exercises. Standard rehabilitation and the active control treatment would be delivered separately by experienced Physiotherapists. Standard TKR rehabilitation would be delivered daily from the first day post surgery till the day of discharge. One day post surgery, patients will perform active control exercises of the affected (operated) limb daily for 15minutes for 4 consecutive days.
Control group
Active

Outcomes
Primary outcome [1] 258809 0
The primary outcome will be isometric knee extensor torque output measured by an isokinetic dynamometer
Timepoint [1] 258809 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Primary outcome [2] 258810 0
Stopwatch-timed fast paced gait speed over a 10-metre course
Timepoint [2] 258810 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Secondary outcome [1] 264876 0
Stopwatch-timed habitual gait speed over a 10-metre course
Timepoint [1] 264876 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Secondary outcome [2] 264877 0
Medical Outcomes Survey Short Form-36 (SF-36) physical function and bodily pain scores
Timepoint [2] 264877 0
Baseline (Pre-operative assessment), 2, 12, and 24 weeks post surgery
Secondary outcome [3] 264878 0
Knee pain intensity measured by the numeric pain rating scale
Timepoint [3] 264878 0
Baseline (Pre-operative assessment), 1 and 4 days post surgery, 2 and 12 weeks post surgery
Secondary outcome [4] 264879 0
Physical activity level as measured by the Lower Extremity Activity Scale (LEAS) questionnaire
Timepoint [4] 264879 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Secondary outcome [5] 264880 0
Walking self-efficacy as measured using a 5-item questionnaire
Timepoint [5] 264880 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Secondary outcome [6] 264881 0
Walking aids used (assistive devices are classified as wheelchair, rollator or walking frame, quadstick, or walking stick) and length of inpatient stay (measured in days using the time from the day of surgery to discharge from the hospital)
Timepoint [6] 264881 0
Day of discharge from hospital
Secondary outcome [7] 264882 0
Quadriceps lag (measured using goniometry) and the visual assessment of the patient's ability to perform an unassisted straight-leg-raise
Timepoint [7] 264882 0
Baseline (Pre-operative assessment), 1 and 4 days post surgery, 2 and 12 weeks post surgery
Secondary outcome [8] 264883 0
Knee extensor maximal rate of torque development (MRTD) and torque steadiness as measured using an isokinetic dynamometer
Timepoint [8] 264883 0
Baseline (Pre-operative assessment), 2 and 12 weeks post surgery
Secondary outcome [9] 264884 0
Knee effusion as measured using a bioimpedance spectrometer and a measuring tape
Timepoint [9] 264884 0
Baseline (Pre-operative assessment), 1 and 4 days post surgery, 2 and 12 weeks post surgery
Secondary outcome [10] 264885 0
Knee passive range-of-motion as measured using goniometry
Timepoint [10] 264885 0
Baseline (Pre-operative assessment), 1 and 4 days post surgery, 2 and 12 weeks post surgery
Secondary outcome [11] 264886 0
Standing balance and weight bearing symmetry as measured using a Wii forceplate
Timepoint [11] 264886 0
Baseline (Pre-operative assessment), 4 days post surgery, 2 and 12 weeks post surgery
Secondary outcome [12] 264887 0
Direct health care costs, as measured by a recall questionnaire of all use of health professionals, medical tests, medications, professional home care and hospitalization
Timepoint [12] 264887 0
12 weeks post surgery
Secondary outcome [13] 264888 0
Health Related Quality of Life: EuroQoL 5D
Timepoint [13] 264888 0
12 weeks post surgery

Eligibility
Key inclusion criteria
Patients undergoing unilateral total knee replacement due to symptomatic knee osteoarthritis
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are (i) trauma leading to TKR, (ii) rheumatoid arthritis and other systemic arthritis, (iii) back or foot/ankle pain which overshadows knee pain, (iv) skin disorder or insensitivity, (v) revision or unicondylar TKR, (vi) inability to walk unaided for short distances preoperatively, (vii) intended transfer to a step-down care facility after TKR, (viii) previous history of stroke or other neurological conditions, and (ix) unable to comply with protocol.

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)
Participants will be identified and recruited from the outpatient orthopaedic clinic of a large tertiary institution in Singapore. Once the participant has provided written informed consent, preoperative testing would be performed and 1 day post surgery, participants will be randomised into one of two groups: (i) standard TKR rehabilitation and NMES and (ii) standard TKR rehabilitation and one set of quadriceps exercises. The randomisation schedule will be prepared by a research physiotherapist who is not involved in the study. He will be the only person with access to the schedule, which will be kept in a locked location. To conceal randomisation, consecutively numbered, sealed, opaque envelopes will be used and maintained centrally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by random permuted blocks stratified according to the 2 physiotherapists delivering the standard TKR rehabilitation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2010
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] 2773 0
Singapore
State/province [1] 2773 0
Singapore

Funding & Sponsors
Funding source category [1] 257301 0
Hospital
Name [1] 257301 0
Singhealth Foundation Grant
Country [1] 257301 0
Singapore
Primary sponsor type
Individual
Name
Yong Hao Pua
Address
Physiotherapy Department
Block 1 Level 1
Singapore General Hospital
Outram Road
S169608
Country
Singapore
Secondary sponsor category [1] 256543 0
None
Name [1] 256543 0
Address [1] 256543 0
Country [1] 256543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259328 0
Singhealth Centralized Institutional Review Board
Ethics committee address [1] 259328 0
Ethics committee country [1] 259328 0
Singapore
Date submitted for ethics approval [1] 259328 0
Approval date [1] 259328 0
29/10/2009
Ethics approval number [1] 259328 0
2009/924/D

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31410 0
Address 31410 0
Country 31410 0
Phone 31410 0
Fax 31410 0
Email 31410 0
Contact person for public queries
Name 14657 0
Yong-Hao Pua
Address 14657 0
Department of Physiotherapy
Singapore General Hospital
Outram Road
Singapore 169608
Country 14657 0
Singapore
Phone 14657 0
+65 90188129
Fax 14657 0
Email 14657 0
[email protected]
Contact person for scientific queries
Name 5585 0
Yong-Hao Pua
Address 5585 0
Department of Physiotherapy
Singapore General Hospital
Outram Road
Singapore 169608
Country 5585 0
Singapore
Phone 5585 0
+65 90188129
Fax 5585 0
Email 5585 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.