Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000781549
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
28/07/2015
Date last updated
28/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chronic effects of simultaneous application of whole-body vibration and neuromuscular electrical stimulation on blood flow in Spinal Cord Injury patients.
Scientific title
Chronic effects of simultaneous application of whole-body vibration and neuromuscular electrical stimulation on blood flow in Spinal Cord Injury
Secondary ID [1] 287013 0
None
Universal Trial Number (UTN)
U1111-1171-6931
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 295479 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295733 295733 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 295734 295734 0 0
Other injuries and accidents
Neurological 295857 295857 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the 12 weeks for the training period, the experimental group, completed a total of 30 sessions (frequency of 3 and 2 sessions a week on alternate weeks). Each session consisted of 10 minutes of simultaneous application of Whole Body Vibration (WBV) and Electromyostimulation (ES) seated in the wheelchair with their feet on the platform. The frequency of vibration was set at 10 Hz and the amplitude at 5 mm (peak to peak). When ES was used, a rectangular, biphasic and symmetric wave with a pulse width of 400 microseconds and 8 Hz was applied. Three, 2-mm-thick, self-adhesive electrodes were used on each leg: one electrode (10x5 cm) was placed about 2 cm below the popliteal fold, and 2 electrodes (5x5 cm) were placed as close as possible to the motor points of the gastrocnemius medialis and lateralis. Current intensity was increased until the subjects motor threshold (mean achieved intensity: 46.6 +/-12.3 mA increasing by 1mA per session.). Finally, interventions were applied by a qualified professional in sport sciences.
Intervention code [1] 292219 0
Treatment: Devices
Comparator / control treatment
"no treatment"
Control group
Active

Outcomes
Primary outcome [1] 295444 0
Popliteal Blood Flow
Popliteal artery was imaged in a longitudinal section with an ultrasound system (MyLab 25, Esaote, Genoa, Italy) using a pulsed color Doppler with a linear array transducer (LA 523, 7.5-12 MHz; length, 50 mm; Esaote, Genua, Italy) in the right popliteal fossa. The probe was positioned to maintain an insonation angle of 60 degree. Each ultrasound image was recorded for a period of 4 s. In that period, there were between 3 and 5 beats, and the mean of these beats was analyzed (MyLab Desk 8.0, Esaote, Genoa, Italy) to obtain mean (MBV) and peak (PBV) arterial systolic blood velocity. Arterial Resting Diameter (RD) was measured as a perpendicular line from the intima-lumen interface of the near to the far wall. Five images were recorded for each measurement. The highest and the smallest values were excluded, and the mean of the three remaining values was used for further analysis. Images were then analyzed using specialized software (MyLabDesk, Esaote Biomedica, Genoa, Italy).
Popliteal artery blood flow was calculated as MBVx3,14(RD/2)2x60. All measurements were performed by the same researcher.
Timepoint [1] 295444 0
Each subject was assessed in 4 different occasions: At baseline (B), after 6 weeks in the half of the training period (Post-6), after 12 weeks at the end of the training period (Post-12) and 8 weeks after the end of the training in order to evaluate the detraining process (D).
Primary outcome [2] 295445 0
Muscle thickness of the gastrocnemius
This is composite primary outcome. Muscle thicknesses of medialis (MG) and lateralis (LG) gastrocnemius were assessed with an ultrasound system (MyLab 25, Esaote, Genoa, Italy). The measurement site was determined at 1/3 proximal of the distance between the lateral epicondyle of the femur and the lateral malleolus of the ankle. This distance was measured with the subjects lying on an examination bed with their knees fully extended. This site was marked on the skin to ensure the repeatability of the measurement. Subjects were asked to remark this reference everyday during the experimental period. Transversal images were recorded from the MG and LG. Five images were recorded for each measurement. The highest and the smallest values were excluded, and the mean of the three remaining values was used for further analysis. Images were then analyzed using specialized software (MyLabDesk, Esaote Biomedica, Genoa, Italy). The same researcher took and analyzed all images.
Timepoint [2] 295445 0
Each subject was assessed in 4 different occasions: At baseline (B), after 6 weeks in the half of the training period (Post-6), after 12 weeks at the end of the training period (Post-12) and 8 weeks after the end of the training in order to evaluate the detraining process (D).
Secondary outcome [1] 315596 0
Bone Mineral Density
BMD was assessed at femoral neck cross-sectional area (total bone surface in a cross-section) by dual-energy x-ray absorption (DXA) with the Norland densitometer (XR-46, USA). DXA is the current standard for measuring BMD. Subjects were supine, with the foot braced and strapped to a plastic triangular frame, ensuring fixed internal rotation of 60 degree.
Timepoint [1] 315596 0
BMD was assessed at baseline (B), and after 12 weeks at the end of the training period (Post-12).

Eligibility
Key inclusion criteria
All the patients were spinal cord injured people and used wheelchair for their locomotion. All the participants were classified by the American Spinal Injury Association Impairment Scale (ASIA) as A and B.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to complete trial period without medication other than antispasticity medication.
Any history of disease such as peripheral arterial disease or other confounding factors.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The normality of the dependent variables was checked and subsequently confirmed using the Shapiro-Wilk test. During the pilot study, the necessary number of participants was set at 20 in order to registered variables could be analyzed using parametric statistical tests. A two-way repeated measures analysis of variance (ANOVA) in group and time was applied. When a significant F-value was achieved, pairwise comparisons were performed using the Bonferroni post hoc procedure. Effect size statistic was provided to determine the magnitude of the effect independently of the sample size. Pearson's correlation coefficient between muscle thickness and resting diameter was calculated. Statistical significance was set at p=0.05. Values were expressed as mean +/-SD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2014
Actual
13/01/2014
Date of last participant enrolment
Anticipated
18/02/2014
Actual
18/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7008 0
Spain
State/province [1] 7008 0
Valladolid

Funding & Sponsors
Funding source category [1] 291562 0
Government body
Name [1] 291562 0
Consejeria de Educacion de Castilla y Leon
Country [1] 291562 0
Spain
Primary sponsor type
Charities/Societies/Foundations
Name
Aspaym Castilla y Leon Foundation
Address
Calle Trevino 74, 47008, Valladolid, Spain.
Country
Spain
Secondary sponsor category [1] 290239 0
University
Name [1] 290239 0
European University of Miguel de Cervantes
Address [1] 290239 0
C/Padre Julio Chevalier, 2, 47012 Valladolid
Country [1] 290239 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293104 0
Comite de Etica de la Fundacion Aspaym Castilla y Leon
Ethics committee address [1] 293104 0
Ethics committee country [1] 293104 0
Spain
Date submitted for ethics approval [1] 293104 0
23/10/2013
Approval date [1] 293104 0
18/12/2013
Ethics approval number [1] 293104 0

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

Contacts
Principal investigator
Name 56706 0
Mr Hector Menendez Alegre
Address 56706 0
Aspaym Castilla y Leon Foundation, Calle Trevino 74, 47008, Valladolid, Spain.
Country 56706 0
Spain
Phone 56706 0
+34 983140080
Fax 56706 0
Email 56706 0
[email protected]
Contact person for public queries
Name 56707 0
Hector Menendez Alegre
Address 56707 0
Aspaym Castilla y Leon Foundation, Calle Trevino 74, 47008, Valladolid, Spain.
Country 56707 0
Spain
Phone 56707 0
+34 983140080
Fax 56707 0
Email 56707 0
[email protected]
Contact person for scientific queries
Name 56708 0
Hector Menendez Alegre
Address 56708 0
Aspaym Castilla y Leon Foundation, Calle Trevino 74, 47008, Valladolid, Spain.
Country 56708 0
Spain
Phone 56708 0
+34 983140080
Fax 56708 0
Email 56708 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
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Documents added automatically
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