Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000515594
Ethics application status
Approved
Date submitted
20/04/2015
Date registered
22/05/2015
Date last updated
22/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined whole-body vibration and neuromuscular electrical stimulation therapy in Spinal Cord Injury patients
Scientific title
Acute effects of simultaneous application of whole-body vibration and neuromuscular electrical stimulation on blood flow in Spinal Cord Injury
Secondary ID [1] 286568 0
Nil known
Universal Trial Number (UTN)
U1111-1169-4513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 294822 0
Condition category
Condition code
Neurological 295094 295094 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 295215 295215 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 295216 295216 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject was assessed in 5 different sessions and all the sessions were separated by at least 48 hours. In the first session subjects were familiarized with the testing procedures and interventions. In the remaining 4 sessions, 4 interventions were applied in random order (one intervention per session). The 4 interventions were: WBV alone (WBV), ES alone (ES), WBV and ES simultaneous (WBV+ES), and 30s of WBV followed by 30s of ES (WBV30/ES30). In these sessions, 10 sets of 1 min of intervention and 1 min of rest were carried out with subjects seated on their own wheelchair with feet placed on the vibration 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 subject’s motor threshold (mean achieved intensity: 46.6 +/-12.3 mA).

Finally, interventions were applied by a qualified profesional in sport sciences.
Intervention code [1] 291678 0
Treatment: Devices
Intervention code [2] 291679 0
Rehabilitation
Comparator / control treatment
The isolated application of WBV or ES.
Control group
Active

Outcomes
Primary outcome [1] 294854 0
Arterial Mean Blood Velocity

The 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) on the right popliteal fossa. The probe was positioned to maintain an insonation angle of 60 degrees. 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) systolic blood velocities
Timepoint [1] 294854 0
at baseline, during the resting minute (in the final 30 s) between the 10 sets, and at the end of each minute during the recovery period
Primary outcome [2] 294855 0
Arterial Peak Blood Velocity

The 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) on the right popliteal fossa. The probe was positioned to maintain an insonation angle of 60 degrees. 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) systolic blood velocities
Timepoint [2] 294855 0
at baseline, during the resting minute (in the final 30 s) between the 10 sets, and at the end of each minute during the recovery period
Secondary outcome [1] 314230 0
Superficial Temperature

Before the blood flow parameters were collected, the surface temperature (ST) of the left gastrocnemius was measured using an infrared thermometer (PCE-777, PCE Instruments, Southampton, United Kingdom). In order to have a reliable measure of this variable, a mark with ink was made between the two gastrocnemius heads
Timepoint [1] 314230 0
at baseline, during the resting minute (in the final 30 s) between the 10 sets, and at the end of each minute during the recovery period

Eligibility
Key inclusion criteria
- People with SCI.
- All the patients used wheelchair for their locomotion.
- All the participants were classified by the American Spinal Injury Association (ASIA) as A or B.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any history of disease such as peripheral arterial disease or other confounding factors.
- Medications were recorded and only antispasticity drugs were allowed during the study.

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)
This study was conducted in a Randomized Crossover design. All the participants received all the treatments in a random order.

Allocation was not concealed
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The normality of the dependent variables was checked and subsequently confirmed using the Shapiro-Wilk test. A two-way repeated measures analysis of variance (ANOVA) in treatment 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 calculated to determine the magnitude of the effect independently of the sample size. Statistical significance was set at p = 0.05.

The number of participants in the study was the maximum that was possible recruit in the Rehabilitation Centre who met the inclusion and exclusion criteria.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2013
Actual
18/02/2013
Date of last participant enrolment
Anticipated
4/03/2013
Actual
4/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 6834 0
Spain
State/province [1] 6834 0
Valladolid

Funding & Sponsors
Funding source category [1] 291129 0
Government body
Name [1] 291129 0
Consejeria de Educacion de Castilla y Leon
Country [1] 291129 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] 289808 0
University
Name [1] 289808 0
European University of Miguel de Cervantes
Address [1] 289808 0
C/Padre Julio Chevalier, 2, 47012 Valladolid
Country [1] 289808 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292708 0
Ethical committee of the Aspaym Castilla y Leon Foundation
Ethics committee address [1] 292708 0
Ethics committee country [1] 292708 0
Spain
Date submitted for ethics approval [1] 292708 0
14/12/2012
Approval date [1] 292708 0
14/01/2013
Ethics approval number [1] 292708 0

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

Contacts
Principal investigator
Name 56670 0
Mr HECTOR MENENDEZ ALEGRE
Address 56670 0
ASPAYM CASTILLA Y LEON FOUNDATION
CALLE TREVINO 74
47008
VALLADOLID
Country 56670 0
Spain
Phone 56670 0
+34 983140080
Fax 56670 0
Email 56670 0
[email protected]
Contact person for public queries
Name 56671 0
HECTOR MENENDEZ ALEGRE
Address 56671 0
ASPAYM CASTILLA Y LEON FOUNDATION
CALLE TREVINO 74
47008
VALLADOLID
Country 56671 0
Spain
Phone 56671 0
+34 983140080
Fax 56671 0
Email 56671 0
[email protected]
Contact person for scientific queries
Name 56672 0
HECTOR MENENDEZ ALEGRE
Address 56672 0
ASPAYM CASTILLA Y LEON FOUNDATION
CALLE TREVINO 74
47008
VALLADOLID
Country 56672 0
Spain
Phone 56672 0
+34 983140080
Fax 56672 0
Email 56672 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.