The effect of sensory mechanical stimulation in the form of neck vibration on walking speed
Design
This is a pre- and post -intervention study in which the samples will be randomly selected.
Settings and conduct
Patients are referred to the study after completing clinical assessments and completing the assessment on a Hoehn and Yahr scale.
Biodex balance machine (Model 30 D_E6N_Sw45) in dynamic mode is used to evaluate patient balance.The overall stability index is a specific equilibrium measurement factor and is extracted by the output of the biodex balancing device, and in various situations without vibration orthosis, the vibration orthosis is closed with the motor off. And the light engine is compared.
Evaluation of patients' walking speed is performed in three stages by Timed UP and GO test:
without closing the vibrating neck orthosis,
with vibrating orthosis while the motor is off,
with vibrating orthosis while the motor is on .
After the patient's initial examination for one month, he/she visits the Physical Medicine and Rehabilitation Department of Firoozgar Hospital for one month a week and receives electrical stimulation through vibration orthosis. Do the same with the methods mentioned above.
Participants/Inclusion and exclusion criteria
inclusion criteria :
People 50-80 years with Parkinson's disease ,Being in one of stages 2 to 4 of the disease severity scale on the Hoehn and Yahr scale ,Having a stable medication regimen for at least the past 3 months
exclusion criteria :
Having a history of falling in the past 6 months , other neurological or mental illnesses ,cardiovascular disease
Intervention groups
The vibration orthosis device is placed on the paraspinal cervical muscles of patients with Parkinson's disease and the patient walks with the device for 15 minutes.
Main outcome variables
overall stability index measured with biodex balance machine,
Timed Up and Go test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190306042945N3
Registration date:2019-11-03, 1398/08/12
Registration timing:registered_while_recruiting
Last update:2019-11-03, 1398/08/12
Update count:0
Registration date
2019-11-03, 1398/08/12
Registrant information
Name
Bijan Forogh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
forogh.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vibration orthosis in the cervical paraspinal muscles on dynamic balance and walking speed in patients with Parkinson's disease.
Public title
The effect of vibration orthosis in the cervical paraspinal muscles on dynamic balance and walking speed in patients with Parkinson's disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 50-80 years with Parkinson's disease
Being in one of stages 2 to 4 of the disease severity scale on the Hoehn and Yahr scale
Having a stable and specific medication regimen for at least the past 3 months
Exclusion criteria:
Having a history of falling in the past 6 months
Having a history of other neurological or mental illnesses
Having a history of cardiovascular disease
Having musculoskeletal disease
Age
From 50 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of Iran University of Medical SciencesStreet addresse
Street address
Iran University of Medical Sciences ,Hemmat Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.IUMS.FMD.REC.1397.248
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Dynamic Equilibrium Rate
Timepoint
zero ,4 weeks, 8 weeks
Method of measurement
Biodex Balancing Machine
2
Description
Walking speed
Timepoint
zero ,4 weeks ,8 weeks.
Method of measurement
Timed Up and Go test
Secondary outcomes
1
Description
side effects
Timepoint
4 weeks ,8 weeks.
Method of measurement
physical examination
Intervention groups
1
Description
Intervention group: Vibration in the paraspinal cervical muscle area by inserting a vibrating orthosis in the Neck, By researcher
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Fahime notghy
Street address
Valadi Ave, Valie asr Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4128 9221
Email
Dr.notghi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Hemmat highway ,near milad tower ,Iran University of Medical science
City
Tehran
Province
Tehran
Postal code
1593477811
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahime Notghi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Valadi Ave,Valie Asr Bld ,Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4128 9221
Email
Dr.notghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Beh Afarin Ave,Valie Asr Square ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 4128 9221
Email
Bijanfr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahime Notghi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Ave, Valie Asr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
Dr.notghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available