Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Effect of tendon vibration during wide-pulse neuromuscular electrical stimulation (NMES) on muscle force production in people with spinal cord injury (SCI)
Secondary ID [1] 293529 0
Nil known
Universal Trial Number (UTN)
U1111-1206-1803
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 305728 0
Condition category
Condition code
Neurological 304939 304939 0 0
Other neurological disorders
Injuries and Accidents 305038 305038 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299768 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304130 0
Measurement of Torque-time integral. Instrument used: Isokinetic dynamometer (Biodex).
Timepoint [1] 304130 0
At the time of each NMES protocol, with the final treatment of each session being the primary timepoint.
Primary outcome [2] 304131 0
Measurements of Peak evoked torque. Instrument used: Isokinetic dynamometer (Biodex).
Timepoint [2] 304131 0
At baseline, at the time of each NMES protocol and immediately after the primary time-point, so following each NMES protocol.
Primary outcome [3] 304132 0
Measurement of number of muscle contractions. Instrument used: Isokinetic dynamometer (Biodex).
Timepoint [3] 304132 0
At the time of each NMES protocol, with the final treatment of each session being the primary timepoint.
Secondary outcome [1] 341041 0
Muscle force measures: maximal and sub maximal evoked force. Instrument used: Isokinetic dynamometer (Biodex).
Timepoint [1] 341041 0
Immediately before the first NMES session and immediately after the last NMES session.

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
1/07/2015
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 18223 0
6027 - Joondalup
Recruitment postcode(s) [2] 18225 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 298142 0
University
Name [1] 298142 0
Edith Cowan University
Country [1] 298142 0
Australia
Primary sponsor type
Individual
Name
Vanesa Bochkezanian
Address
Central Queensland University. Bruce Highway, North Rockhampton, Queensland, Australia (4702)
Country
Australia
Secondary sponsor category [1] 297225 0
Charities/Societies/Foundations
Name [1] 297225 0
Spinal Cord Injuries Australia
Address [1] 297225 0
1 Jennifer St, Little Bay, NSW, Australia (2036).
Country [1] 297225 0
Australia
Secondary sponsor category [2] 297228 0
Individual
Name [2] 297228 0
Anthony J. Blazevich
Address [2] 297228 0
Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
Country [2] 297228 0
Australia
Secondary sponsor category [3] 297229 0
Individual
Name [3] 297229 0
Robert U. Newton
Address [3] 297229 0
Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
Country [3] 297229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299160 0
Edith Cowan University Research Ethics Committee
Ethics committee address [1] 299160 0
Ethics committee country [1] 299160 0
Australia
Date submitted for ethics approval [1] 299160 0
14/01/2015
Approval date [1] 299160 0
27/01/2015
Ethics approval number [1] 299160 0
11623

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2242 2242 0 0
/AnzctrAttachments/374111-Ethics approval PhD 1.pdf (Ethics approval)
Attachments [2] 2243 2243 0 0
/AnzctrAttachments/374111-Ethics approval PhD 2 and 3.pdf (Ethics approval)
Attachments [3] 2244 2244 0 0
/AnzctrAttachments/374111-Bochkezanian et al, 2017.pdf (Publication)
Attachments [4] 2245 2245 0 0
/AnzctrAttachments/374111-S2 informed consent .docx (Participant information/consent)

Contacts
Principal investigator
Name 79502 0
Dr Vanesa Bochkezanian
Address 79502 0
Central Queensland University. Bruce Highway, North Rockhampton, QLD, Australia (4702).
Country 79502 0
Australia
Phone 79502 0
+61 7 49306453
Fax 79502 0
Email 79502 0
v.bochkezanian@cqu.edu.au
Contact person for public queries
Name 79503 0
Vanesa Bochkezanian
Address 79503 0
Central Queensland University. Bruce Highway, North Rockhampton, QLD, Australia (4702)
Country 79503 0
Australia
Phone 79503 0
+61 7 49306453
Fax 79503 0
Email 79503 0
v.bochkezanian@cqu.edu.au
Contact person for scientific queries
Name 79504 0
Anthony Blazevich
Address 79504 0
Edith Cowan University, 270 Joondalup drive. Joondalup, Western Australia (6027).
Country 79504 0
Australia
Phone 79504 0
+61 8 63045472
Fax 79504 0
Email 79504 0
a.blazevich@ecu.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseEffect of tendon vibration during wide-pulse neuromuscular electrical stimulation (NMES) on muscle force production in people with spinal cord injury (SCI).2018https://dx.doi.org/10.1186/s12883-018-1020-9
N.B. These documents automatically identified may not have been verified by the study sponsor.