1)Objective: to evaluate the effect of applying vibratory belt on improving static and dynamic balance in CVA hemiparetic patients
2)Design: Body imbalance is a common problem in hemiparetic CVA patients. Impaired postural control could be an important complication of their illness. It can increase the risk of falling and fractures during and after rehabilitation phase in this population. A new modality which can possibly help to improve balance in these patients is somatosensory stimulation. There is few clinical trials to date which evaluate vibration as a somatosensory stimulation especially focal vibration instead of whole body vibration to improve balance. Vibrational somatosensory stimulation in Parkinson disease was shown to improve balance control.in this cross-over clinical trial we are going to design a vibratory belt and assesse the locally used vibration effect (phase 2)on 20 hemiparetic post CVA patients referred to the Firoozgar hospital physical medicine and rehabilitation center(single center), by using Biodex balance system static and dynamic tests. Due to vibratory cue during the test, this study will not be blind neither for the participants nor the person who accomplishes the tests and gathers the data.
3)Setting and conduct: four different positions(static/dynamic and open/closed eye) while applying lumbar belt with Vibration ON/OFF, will evaluate separately in one session for each patient by overall stability index measured with Biodex balance system. Before applying the belt the patient’s balance will be tested, and will compare with the test result during applying the belt. Biodex balance system include tow balance platforms (soft and hard) with 12 different degrees of stability from easy to difficult. The system also contains a monitor in front of the patient to accomplish the selected balance test according the visual clues shown in the monitor.
4) Inclusion criteria are: post stroke hemiparesia; at least one month passed after stroke episode; patients must experience only one stroke attack; be able to maintain independent unsupported stance for at least 30 seconds. Exclusion criteria are: patients who had orthopaedic impairment with significant impact on standing balance; severe spasticity interfere with standing balance; cerebellar or brain stem induced balance impairment; history of vestibular balance impairment or severe peripheral neuropathy and cardiac pace maker.
5)Intervention in this study is applying the vibratory belt during the static and dynamic balance tests (which will be done with Biodex balance system)
6)Primary outcome measure: over all stability index (OSI) in 4 different positions (static/dynamic and open/closed eye) before applying the vibratory belt.
Secondary outcome measure: over all stability index (OSI) in 4 different positions (static/dynamic and open/closed eye) during applying the vibratory belt.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122611890N1
Registration date:2017-02-25, 1395/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-25, 1395/12/07
Registrant information
Name
Arash Majdzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
a-majdzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of somatosensory stimulation through a vibratory orthosis on balance control in hemiparetic stroke patients
Public title
Effect of vibratory orthosis on balance control in hemiparetic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: post stroke hemiparesia; at least one month passed after stroke episode; patients must experience only one stroke attack; be able to maintain independent unsupported stance for at least 30 seconds.
Exclusion criteria: patients who had orthopedic impairment with significant impact on standing balance; severe spasticity interfere with standing balance; cerebellar or brain stem induced balance impairment; history of vestibular balance impairment or severe peripheral neuropathy and cardiac pace maker.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commity of Tehran University of Medical Science