The Effect of Dry Needling on Upper and Lower Limb Dysfunction of Stroke Patients
Design
Double blind, sham controlled, randomized
Settings and conduct
A randomized clinical trial was conducted on 24 patients with a stroke who had been identified with a definitive diagnosis in Imam Khomeini Hospital and had hemiplegia. Patients are randomly selected randomly in one of the two intervention groups and the control group based on entry criteria and consent to participate in the research.
Participants/Inclusion and exclusion criteria
18-75 years;
first brain stroke;
Sufficient communication skills to show yes / no verbally or through gestures;
be able to walk for at least 10 meter;
unilateral hemiparesis.
Intervention groups
A specialist who has expertise in dry needling, will deliver three sessions of dry needling on the flexor carpiradialis and flexor carpiulnaris muscles of the upper extremity and gastrocnemius muscle of the lower extremity on the affected side the intervention group.
Evaluation the effect of dry needling on the spasticity of aforementioned muscles on the affected side will do immediately after last session of dry needling and after 1 month of baseline, in comparison with baseline information gained before doing dry needling in the intervention group.
All these procedures will do for control group but using placebo dry needling instead of dry needling for control group.
Main outcome variables
spasticity (MMAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037388N4
Registration date:2019-04-07, 1398/01/18
Registration timing:retrospective
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Ardalan Shariat
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 939 861 4772
Email address
a-shariat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-01, 1397/03/11
Expected recruitment end date
2019-02-01, 1397/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Dry Needling on Upper and Lower Dysfunction on stroke patients
Public title
The Effectiveness of Dry Needling on Spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
first brain stroke
Sufficient communication skills to show yes / no verbally or through gestures
be able to walk for at least 10 meter
MMAS score equal or more than one
unilateral hemiparesis
Exclusion criteria:
unable patients to follow the instructions
severe musculoskeletal disorders (For example, severe osteoporosis, arthritis}
psychiatric disorders requiring drug therapy
cognitive disorders
contraindication to dry needling
using anti-spastic drugs
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the random number table, patients are placed in one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are not aware of being in the intervention group or the control group. The control group will receive the intervention once the study finished. In addition, both group participate in their conventional therapies. Measurements are performed by an assessor who does not know the training protocols that each group has done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee Ethics Committee of Tehran University of Medical Sciences
Street address
No 7, Al-e-Ahmad Highway, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
14395-578
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.TUMS.VCR.REC.1397.721
Health conditions studied
1
Description of health condition studied
Brain Stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as hemorrhage or infarction
Primary outcomes
1
Description
Walking speed
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
10 meter walking test
2
Description
spasticity
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
modified modified ashworth scale
3
Description
mobility
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
Timed up and go test
4
Description
hand dexterity
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
Box and Block test
Secondary outcomes
1
Description
Balance
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
Single Leg Stance Test
2
Description
Daily living activity
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
Barthel index
3
Description
range of motion
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
goniometer
4
Description
pennation angle of gastrocnemius muscle
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
sonography
5
Description
gastrocnemius muscle thickness
Timepoint
Baseline, immediately after treatment and after 4 weeks
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: A specialist who has expertise in dry needling, will deliver three sessions of dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions. At baseline, immediately after last session of dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests.
Category
Treatment - Devices
2
Description
Control group: A specialist who has expertise in dry needling, will deliver three sessions of placebo dry needling on the spastic muscles of the upper and lower extremities on the hemiplegic side with a 48 hours interval between sessions.At baseline, immediately after last session of placebo dry needling and after 1 month of baseline, the blind assessor, expert physiotherapist, will perform the clinical tests.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Prof.Noureddin Nakhostin Ansari
Street address
Gharib Ave, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 6119 0000
Email
nakhostin@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi, Research Vice-Dept. of Neuro Res Cen, Tehran University of Medical Sciences
Street address
No 7, Al-e-Ahmad Highway, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 8863 0227
Fax
Email
ramin_kordi@tums.ac.ir
Grant name
Research Vice-Dept. of Neuroscience Research Center, Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Post doctoral Fellow
Latest degree
Ph.D.
Other areas of specialty/work
Neurorehabilitation
Street address
alale ale ahmad, Sports Medicine Research Center
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
post doctoral fellow
Latest degree
Ph.D.
Other areas of specialty/work
Neurorehabilitation
Street address
sports Medicine research center, jalale ale ahmad
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ardalan Shariat
Position
Post doctoral Fellow
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Jalale ale ahmad, Sports Medicine Research Center
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 939 861 4772
Email
ardalansh2002@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
All the data will be shared after removing identification details of participants.
We will publish the results as a scientific article without any name from participants.
When the data will become available and for how long
After finish the protocol, the article will be published and will be available permanently.
To whom data/document is available
data is only available for people working in academic institutions
Under which criteria data/document could be used
For academic purpose
From where data/document is obtainable
Ardalansh2002@gmail.com Dr.Ardalan Shariat
What processes are involved for a request to access data/document