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Trial registered on ANZCTR
Registration number
ACTRN12618000022268
Ethics application status
Approved
Date submitted
5/12/2017
Date registered
11/01/2018
Date last updated
11/01/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of electrical stimulation and tendon vibration on muscle force in people with spinal cord injury
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Scientific title
Effect of tendon vibration during wide-pulse neuromuscular electrical stimulation (NMES) on muscle force production in people with spinal cord injury (SCI)
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Secondary ID [1]
293529
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Nil known
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Universal Trial Number (UTN)
U1111-1206-1803
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
spinal cord injury
305728
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Condition category
Condition code
Neurological
304939
304939
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0
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Other neurological disorders
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Injuries and Accidents
305038
305038
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Neuromuscular electrical stimulation (NMES) to both quadriceps femoris muscles. It was delivered by the principal investigator, who was a Senior Physiotherapist, the mode of delivery was face to face. The number of times the intervention was delivered was 3 times, the duration was for one hour each session, once a week for 3 weeks. The experimental conditions were two. The first session was a familiarisation session and the following two were experimental sessions with conditions completed in a randomised order. The aim of this study was to replicate the most efficient NMES protocol found in Study 1 in healthy population to provide the greatest total impulse and lowest fatigue rate, imposed both with and without simultaneous tendon vibration, to investigate acute effects in people with SCI.
The "wash-out" period between the interventions was of a minimum of 72 hours.
NMES was delivered by a high-voltage constant-current electrical stimulator (400 V, DS7A, Digitimer Ltd., Welwyn Garden City, UK) under the same conditons as the assessment through four self-adhesive stimulation electrodes (Axelgaard, PALS, USA) placed over the rectus femoris (RF), vastus lateralis (VL), and vastus medialis (VM). Two 5×10 cm electrodes were placed over RF and one 5×5 electrode was placed on each of the VM and VL approximately at their motor points using a split end cable, to increase the surface area of stimulation. The electrodes were placed to elicit the greatest twitch response with a low stimulation intensity. Long quadriceps muscle length was chosen to elicit greater hypertrophy.
Each session commenced with a “warm-up” period consisting of paired electrical square-wave stimuli (two 1000 µs square-wave pulses with 5–ms interpulse interval) followed by a maximum of three tetanic trains delivered to each leg separately every 20 s while the stimulation current was increased from 30 mA in 10-mA increments until a plateau in the maximum peak twitch torque was observed or the maximal current intensity was 99 mA. This plateau was defined as the maximal peak twitch torque (?tw,p) and was used as the target torque during the training session. Subsequently, a tetanic train of NMES at 40 mA (?t,40mA) was delivered followed by a maximum of three trains of NMES performed at different stimulation current intensities until reaching the closest value to the target torque.
After the warm-up period the NMES session commenced with electrically-evoked muscle contractions being elicited at the target torque for 5 sets of 10 repetitions on each leg, with a 1-min rest between sets. To determine the actual training intensity either one of two methods was used. The first method was by evoking the maximal peak (doublet) twitch torque and setting the current so the tetanic torque was equal to ?peak twitch torque. However, on some days the peak twitch torque showed a decrease compared to previous sessions. In these cases, a second method was used whereby the starting current was set to be equal to the highest current used in the previous training session. Within each session, the current was increased by 2 mA per each set of 10 repetitions to maintain a high torque production as fatigue developed; thus, if the second method was chosen, the current selected for set 1 was the same as that used in the final set of the previous session. Using this method, the torque produced in set 1 of training was always higher than that performed in any set of the previous session and thus the evoked torque increased incrementally.
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Intervention code [1]
299768
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
304130
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Measurement of Torque-time integral. Instrument used: Isokinetic dynamometer (Biodex).
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Assessment method [1]
304130
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Timepoint [1]
304130
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At the time of each NMES protocol, with the final treatment of each session being the primary timepoint.
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Primary outcome [2]
304131
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Measurements of Peak evoked torque. Instrument used: Isokinetic dynamometer (Biodex).
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Assessment method [2]
304131
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Timepoint [2]
304131
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At baseline, at the time of each NMES protocol and immediately after the primary time-point, so following each NMES protocol.
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Primary outcome [3]
304132
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Measurement of number of muscle contractions. Instrument used: Isokinetic dynamometer (Biodex).
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Assessment method [3]
304132
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Timepoint [3]
304132
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At the time of each NMES protocol, with the final treatment of each session being the primary timepoint.
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Secondary outcome [1]
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Muscle force measures: maximal and sub maximal evoked force. Instrument used: Isokinetic dynamometer (Biodex).
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Assessment method [1]
341041
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Timepoint [1]
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Immediately before the first NMES session and immediately after the last NMES session.
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Eligibility
Key inclusion criteria
Inclusion criteria: age 18-65 years; SCI longer than 6 months that led to complete or incomplete paraplegia or tetraplegia; level of injury between C2 and L5; AIS (American Spinal Cord Injury Association Impairment Scale) A, B, C or D; have medical permission to enrol in an intensive exercise program; and able to participate in the program over a 14-week period.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Acute phase of injury (less than 6 months from injury); ventilator dependent, other associated neurological disease; and complications such as severe urinary infection, pressure ulcers, previous lower-limb fractures or any other health condition that may constrain the participation in an exercise program.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Two-way repeated measures analysis of variance (ANOVA) was used to compare changes in all variables between conditions (STIM, STIM+Vib) over time (PRE, POST). A Wilcoxon test was conducted to compare STIM, STIM+Vib between PRE-and POST in positive and negative responders to patellar tendon vibration whilst using assessments at PRE as the covariates. Pairwise t-tests were performed when significant interaction effects were found. A chi- square test for independence was used to assess whether an association existed between subjects with complete and incomplete SCI and the likelihood of being a positive or negative responders. Statistical significance was set at an alpha level of p equals to 0.05 and values are reported as mean and SD.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/04/2015
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Date of last participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last data collection
Anticipated
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Actual
30/09/2016
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Sample size
Target
10
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Accrual to date
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Final
9
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment postcode(s) [1]
18223
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6027 - Joondalup
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Recruitment postcode(s) [2]
18225
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6000 - Perth
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Funding & Sponsors
Funding source category [1]
298142
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University
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Name [1]
298142
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Edith Cowan University
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Address [1]
298142
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270 Joondalup drive. Joondalup. Western Australia (6027).
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Country [1]
298142
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Australia
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Primary sponsor type
Individual
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Name
Vanesa Bochkezanian
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Address
Central Queensland University. Bruce Highway, North Rockhampton, Queensland, Australia (4702)
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Country
Australia
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Secondary sponsor category [1]
297225
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Charities/Societies/Foundations
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Name [1]
297225
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Spinal Cord Injuries Australia
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Address [1]
297225
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1 Jennifer St, Little Bay, NSW, Australia (2036).
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Country [1]
297225
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Australia
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Secondary sponsor category [2]
297228
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Individual
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Name [2]
297228
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Anthony J. Blazevich
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Address [2]
297228
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Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
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Country [2]
297228
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Australia
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Secondary sponsor category [3]
297229
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Individual
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Name [3]
297229
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Robert U. Newton
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Address [3]
297229
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Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
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Country [3]
297229
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299160
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Edith Cowan University Research Ethics Committee
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Ethics committee address [1]
299160
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270 Joondalup drive. Joondalup, Western Australia (6027)
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Ethics committee country [1]
299160
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Australia
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Date submitted for ethics approval [1]
299160
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14/01/2015
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Approval date [1]
299160
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27/01/2015
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Ethics approval number [1]
299160
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11623
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Summary
Brief summary
Ten subjects with SCI already involved in an activity-based exercise/rehabilitation program visited the Neuromuscular Physiology laboratory at Edith Cowan University on three occasions at the same time of day separated at least by 72 h. The experimental conditions were only be two in this Study 2. The first session was a familiarisation session and the following two were experimental sessions with conditions completed in a randomised order. The aim of this study was to replicate the most efficient NMES protocol found in Study 1 in healthy population to provide the greatest total impulse and lowest fatigue rate, imposed both with and without simultaneous tendon vibration, to investigate acute effects in people with SCI.
Electrical stimulation protocol
Participants sat on a test chair and will be given twitches of electrical stimulation of the thigh muscle while their leg was held stationary by a testing machine (isokinetic dynamometer). Two passive electrodes were placed on the skin over their stronger thigh muscle (quadriceps) and they were given one of the electrical stimulation protocols. All of these procedures were safe, and are commonly performed at Edith Cowan University.
The purpose of the present study was to determine whether patellar tendon vibration superimposed onto wide-pulse width NMES under standard clinical conditions elicits a greater peak muscle force with less muscle fatigue (i.e. a greater total impulse) when compared to NMES applied without patellar tendon vibration in people with SCI. We hypothesised that patellar tendon vibration superimposed onto wide-pulse width NMES would elicit a greater peak muscle force with less muscle fatigue (i.e. a greater total impulse) that NMES applied without patellar tendon vibration in people with SCI.
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Trial website
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Trial related presentations / publications
Bochkezanian, V., Newton, R. U., Trajano, G. S., Vieira, A., Pulverenti, T. S., & Blazevich, A. J. (2017). Effect of tendon vibration during wide-pulse neuromuscular electrical stimulation (NMES) on the decline and recovery of muscle force. BMC Neurology, 17(1), 82. doi:10.1186/s12883-017-0862-x
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Public notes
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Attachments [1]
2242
2242
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/AnzctrAttachments/374111-Ethics approval PhD 1.pdf
(Ethics approval)
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Attachments [2]
2243
2243
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/AnzctrAttachments/374111-Ethics approval PhD 2 and 3.pdf
(Ethics approval)
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Attachments [3]
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2244
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/AnzctrAttachments/374111-Bochkezanian et al, 2017.pdf
(Publication)
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Attachments [4]
2245
2245
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/AnzctrAttachments/374111-S2 informed consent .docx
(Participant information/consent)
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Contacts
Principal investigator
Name
79502
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Dr Vanesa Bochkezanian
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Address
79502
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Central Queensland University. Bruce Highway, North Rockhampton, QLD, Australia (4702).
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Country
79502
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Australia
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Phone
79502
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+61 7 49306453
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Fax
79502
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Email
79502
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[email protected]
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Contact person for public queries
Name
79503
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Dr Vanesa Bochkezanian
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Address
79503
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Central Queensland University. Bruce Highway, North Rockhampton, QLD, Australia (4702)
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Country
79503
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Australia
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Phone
79503
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+61 7 49306453
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Fax
79503
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Email
79503
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[email protected]
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Contact person for scientific queries
Name
79504
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Prof Anthony Blazevich
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Address
79504
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Edith Cowan University, 270 Joondalup drive. Joondalup, Western Australia (6027).
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Country
79504
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Australia
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Phone
79504
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+61 8 63045472
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Fax
79504
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Email
79504
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[email protected]
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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
Embase
Effect of tendon vibration during wide-pulse neuromuscular electrical stimulation (NMES) on muscle force production in people with spinal cord injury (SCI).
2018
https://dx.doi.org/10.1186/s12883-018-1020-9
N.B. These documents automatically identified may not have been verified by the study sponsor.
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