Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000703909
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
8/07/2011
Date last updated
8/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinematic analysis of reaching movement after segmental muscle vibration therapy in patients with chronic stroke: a randomized controlled trial
Scientific title
In patients with hemiparesis following a stroke, is the addition of segmental muscle vibration therapy to exercise more effective than exercise alone in modifying reaching movement?
Secondary ID [1] 262585 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic stroke 268253 0
Condition category
Condition code
Neurological 268386 268386 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Segmental muscle vibration (SMV) is a technique that applies a vibratory stimulus to a specific muscle using a mechanical device. When applied to a muscle–tendon unit, SMV induces the generation of Ia inputs as a consequence of activation of muscle spindle primary endings. The Ia inputs activated by SMV can alter the excitability of the corticospinal pathway by modulation of intracortical inhibiting and facilitating inputs to the primary motor cortex. Indeed, recent transcranial magnetic stimulation (TMS)
studies have shown increased excitability in the primary
motor cortex representation of the vibrated muscle following
the application of low-amplitude SMV to the flexor carpi radialis muscle and intrinsic hand muscles in healthy
subjects. Moreover, SMV applied to healthy subjects effectively compensates for repetitive TMS-induced inhibition
of the prefrontal cortex. It has been demonstrated that SMV
added to general physical therapy may improve gait performance in patients with foot drop secondary to chronic stroke. SMV is chracterized by amplitude of displacement (mm), frequency (Hz) and duration of application. Particularly suited for application in neurological condition are low amplitude (0.01 mm), high frequency (120 Hz) stimuli, applied for 30 minutes/day, 5 days/week over a total of 2 weeks.
Patients will also receive exercise therapy consisting in stretching, strengthening, proprioceptive training and reaching training. Exercise will be performed under the guidance of a physical therapist with experience in the field of stroke rehabilitation, 60 minutes/day, 5 days/week over a total of 2 weeks. Exercise therapy will be delivered at the end of each SMV session.
Intervention code [1] 266917 0
Treatment: Devices
Intervention code [2] 266929 0
Rehabilitation
Comparator / control treatment
Exercise therapy consists in stretching, strengthening, proprioceptive training and reaching training. Exercise will be performed under the guidance of a physical therapist with experience in the field of stroke rehabilitation, 60 minutes/day, 5 days/week over a total of 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 269151 0
Improvement of mean linear speed (m/s) during reaching movement, as measured by instrumental kinematic analysis
Timepoint [1] 269151 0
Two weeks and four weeks after treatment starts.
Primary outcome [2] 269152 0
Improvement in the smoothness of movement, as measured by normalized jerk, i.e. the third derivative of displacement, through instrumental kinematic analysis
Timepoint [2] 269152 0
Two weeks and four weeks after treatment starts.
Secondary outcome [1] 279040 0
Changes in upper limb kinematics at the end of reaching movement, as measured by quantifying elbow extension and shoulder flexion angles.
Timepoint [1] 279040 0
Two weeks and four weeks after treatment starts.

Eligibility
Key inclusion criteria
Right or left hemiplegia of at least 6 months duration, secondary to magnetic resonance imaging–documented chronic ischemic stroke.
Minimum age
45 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral brain lesions, ischemic involvement of the cerebellum or basal ganglia, aphasia, psychiatric disease, cognitive impairment (Mini-Mental State Exam evaluation <23), and previous history of neurological diseases, diabetes, or rheumatic and orthopedic conditions that may interfere with upper limb movement. Patients are
also excluded if they are involved in other clinical trials or if
they are under antispasticity therapy.

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)
Participants will be randomly assigned to either an experimental group or a control group by an independent person who will select a sealed envelope 30 minutes before the intervention is due to start.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
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] 3701 0
Italy
State/province [1] 3701 0

Funding & Sponsors
Funding source category [1] 267393 0
University
Name [1] 267393 0
Sapienza University of Rome
Country [1] 267393 0
Italy
Primary sponsor type
University
Name
Sapienza University of Rome
Address
piazzale Aldo Moro, 5
00185, Rome
Country
Italy
Secondary sponsor category [1] 266453 0
Hospital
Name [1] 266453 0
Azienda Policlinico Umberto I, Rome
Address [1] 266453 0
piazzale Aldo Moro, 5
00185, Rome
Country [1] 266453 0
Italy

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 32844 0
Address 32844 0
Country 32844 0
Phone 32844 0
Fax 32844 0
Email 32844 0
Contact person for public queries
Name 16091 0
Marco Paoloni
Address 16091 0
Physical Medicine and Rehabilitation unit
Azienda Policlinico Umberto I
piazzale Aldo Moro, 5
00185 Rome
Country 16091 0
Italy
Phone 16091 0
+396491672
Fax 16091 0
Email 16091 0
[email protected]
Contact person for scientific queries
Name 7019 0
Marco Paoloni
Address 7019 0
Physical Medicine and Rehabilitation unit
Azienda Policlinico Umberto I
piazzale Aldo Moro, 5
00185 Rome
Country 7019 0
Italy
Phone 7019 0
+396491672
Fax 7019 0
Email 7019 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.