Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000752864
Ethics application status
Approved
Date submitted
9/07/2012
Date registered
16/07/2012
Date last updated
16/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of whole body vibration in stroke patients
Scientific title
Effects of whole body vibration on muscle architecture, muscle strength and balance in stroke patients
Secondary ID [1] 280823 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 286891 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287209 287209 0 0
Physiotherapy
Stroke 287224 287224 0 0
Haemorrhagic
Stroke 287233 287233 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group received a whole body vibration treatment with an increase in the frequency (from 5 to 21 Hz), sets (from 4 to 7) and the time per set (from 30 to 60 s) over 17 sessions (2 sessions per week). Each subject was placed standing on a vibration platform (Galileo Home, Galileo, Novotec, Germany), with a knee flexion of 30 degrees (taking 0 degrees as the anatomical position). In front of the subject was a wall bar that could be grabbed if they were to fall. In each set, the vibration was applied first in the medio-lateral axis (ML, with the feet parallel to the lower edge of the platform) and, then in the antero-posterior axis (AP, with the feet parallel to the longest edge of the platform). These foot positions determined the vibration amplitude, which ranged between 4 and 6 mm peak to peak.
Intervention code [1] 285249 0
Treatment: Devices
Intervention code [2] 285258 0
Rehabilitation
Comparator / control treatment
Each subject was placed standing on a vibration platform. The experimental group received a whole body vibration treatment, with an increase in frequency, sets, and time per set over 17 sessions. The sham group -control- performed the same exercises as the experimental group, but were not exposed to the vibration.
Control group
Placebo

Outcomes
Primary outcome [1] 287496 0
Muscle architecture (rectus femoris, vastus lateralis and medial gastrocnemious) assessed by an ultrasound system (MyLab25, Esaote, Genua, Italy) with a linear array probe (LA 523, 7.5-12 MHz; probe length, 50 mm; Esaote, Genua
Timepoint [1] 287496 0
Timepoint: Baseline and 3 months.
Secondary outcome [1] 298276 0
Outcome variables included the maximal isometric voluntary contraction of knee extensors by isokinetic dynamometry (Biodex 4, Shirley, NY).
Timepoint [1] 298276 0
Timepoint: Baseline and 3 months.
Secondary outcome [2] 298288 0
Berg balance scale.
Timepoint [2] 298288 0
Timepoint: Baseline and 3 months.

Eligibility
Key inclusion criteria
Inclusion criteria were to have suffered an ischemic or hemorrhagic stroke 6 or more months prior to the study, and a National Institute of Health Stroke Scale (NIHSS) score greater than 1 and less than 20.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with dementia or severe cognitive impairment, patients with knee joint pain (not neurological pain), and patients who were not able to remain standing without external support for at least 30 s were excluded.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4399 0
Spain
State/province [1] 4399 0
Valladolid

Funding & Sponsors
Funding source category [1] 285616 0
Government body
Name [1] 285616 0
Ministry of Health of the Junta de Castilla y Leon.
Country [1] 285616 0
Spain
Primary sponsor type
Charities/Societies/Foundations
Name
La ASociacion de PAraplejicos Y grandes Minusvalidos (ASPAYM) de Castilla y Leon
Address
C/ Trevino, 74

47008 - Valladolid - Spain
Country
Spain
Secondary sponsor category [1] 284448 0
University
Name [1] 284448 0
European University Miguel de Cervantes
Address [1] 284448 0
c/ Padre Julio Chevalier 2
47012-Valladolid- Spain
Country [1] 284448 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287623 0
La ASociacion de PAraplejicos Y grandes Minusvalidos (ASPAYM) de Castilla y Leon.
Ethics committee address [1] 287623 0
C/ Trevino, 74

47008 - Valladolid - Spain
Ethics committee country [1] 287623 0
Spain
Date submitted for ethics approval [1] 287623 0
Approval date [1] 287623 0
Ethics approval number [1] 287623 0

Summary
Brief summary
Background. Whole-body vibrations (WBV) have recently been applied and investigated as a rehabilitation method.
Objective. The aim of the present study was to analyze the effects of WBV on lower limb muscle architecture, muscle strength, and balance in stroke patients over a period of 3 months.
Design. The study used a prospective, randomized, before-after trial design. Inclusion criteria were to have suffered an ischemic or hemorrhagic stroke 6 or more months prior to the study, and a National Institute of Health Stroke Scale (NIHSS) score greater than 1 and less than 20.
Patients. Patients were randomly divided into two groups: an experimental group (EG; n = 11) and a sham group (SG; n = 9).
Intervention. Each subject was placed standing on a vibration platform. The EG received a WBV treatment, with an increase in frequency, sets, and time per set over 17 sessions. The SG performed the same exercises as the EG, but were not exposed to the vibration.
Measurements. Outcome variables included the muscle architecture (rectus femoris, vastus lateralis and medial gastrocnemious), maximal isometric voluntary contraction of knee extensors, and Berg balance scale.
Trial website
Trial related presentations / publications
Under review
Public notes

Contacts
Principal investigator
Name 34417 0
Address 34417 0
Country 34417 0
Phone 34417 0
Fax 34417 0
Email 34417 0
Contact person for public queries
Name 17664 0
Pedro J. Marin
Address 17664 0
European University Miguel de Cervantes
c/ Padre Julio Chevalier 2
47012-Valladolid
Country 17664 0
Spain
Phone 17664 0
+34 647856968
Fax 17664 0
+34 983 278 958
Email 17664 0
[email protected]
Contact person for scientific queries
Name 8592 0
Pedro J. Marin
Address 8592 0
European University Miguel de Cervantes
c/ Padre Julio Chevalier 2
47012-Valladolid (Spain)
Country 8592 0
Spain
Phone 8592 0
+34 647856968
Fax 8592 0
+34 983 278 958
Email 8592 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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