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General information
2020-01-20, 1398/10/30
2021-08-22, 1400/05/31
20202021-0108-2022 00:00:00
2020-09-19, 1399/06/29
2022-09-20, 1401/06/29
20202022-09-1920 00:00:00
empty
Unfortunately, due to the corona pandemic, the start of data collecting of patient was delayed.
Unfortunately, due to the corona pandemic, the start of data collecting of patient was delayed.
empty
متاسفانه بدلیل پاندمی کرونا شروع نمونه گیری بیماران به تاخیر افتاد.
متاسفانه بدلیل پاندمی کرونا شروع نمونه گیری بیماران به تاخیر افتاد.
Recruitment centers
#1
Name of recruitment center - English: National Brain Mapping Lab
Name of recruitment center - Persian: آزمایشگاه ملی نقشه برداری
Full name of responsible person - English: Mohamadreza Ay
Full name of responsible person - Persian: محمد رضا آی
Street address - English: Iran, Tehran, North Kargar Street, Campus of Technical Schools, South Side of the Faculty of Electrical Engineering
Street address - Persian: ایران، تهران، خیابان کارگر شمالی، پردیس دانشکده های فنی، ضلع جنوبی دانشکده برق
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439957131
Phone: +98 21 8609 3109
Fax: +98 21 8609 3160
Email: info@nbml.ir
Web page address: https://nbml.ir/FA/pages/about
Name of recruitment center - English: National Brain Mapping Lab
Name of recruitment center - Persian: آزمایشگاه ملی نقشه برداری
Full name of responsible person - English: Mohamadreza Ay
Full name of responsible person - Persian: محمد رضا آی
Street address - English: South side of the Faculty of Electrical Engineering,Campus of Technical Schools,Kargar North Street,Tehran,Iran
Street address - Persian: ایران، تهران، پردیس دانشکده های فنی، ضلع جنوبی دانشکده برق
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439957131
Phone: +98 21 8609 3109
Fax: +98 21 8609 3160
Email: info@nbml.ir
Web page address: https://nbml.ir/FA/pages/about
Name of recruitment center - English: National Brain Mapping Lab Name of recruitment center - Persian: آزمایشگاه ملی نقشه برداری Full name of responsible person - English: Mohamadreza Ay Full name of responsible person - Persian: محمد رضا آی Street address - English: Iran, Tehran, North Kargar Street, Campus of Technical Schools, South Sideside of the Faculty of Electrical EngineeringEngineering,Campus of Technical Schools,Kargar North Street,Tehran,Iran Street address - Persian: ایران، تهران، خیابان کارگر شمالی، پردیس دانشکده های فنی، ضلع جنوبی دانشکده برق City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439957131 Phone: +98 21 8609 3109 Fax: +98 21 8609 3160 Email: info@nbml.ir Web page address: https://nbml.ir/FA/pages/about
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr M ohamadreza khodaei ardakani
Full name of responsible person - Persian: دکتر محمدرضا خدایی اردکانی
Street address - English: ,evin ,daneshjoo blvd,koodakyar deadlock
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار ,
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0092
Fax:
Email: rd@uswr.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr M ohamadreza khodaei ardakani
Full name of responsible person - Persian: دکتر محمدرضا خدایی اردکانی
Street address - English: Second Floor,Farabi Building ,University of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار , دانشگاه علوم بهزیستی و توانبخشی ،ساختمان فارابی ،طبقه دوم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0092
Fax:
Email: rd@uswr.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr M ohamadreza khodaei ardakani Full name of responsible person - Persian: دکتر محمدرضا خدایی اردکانی Street address - English: ,evinSecond Floor,Farabi Building ,daneshjoo blvd,koodakyar deadlockUniversity of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار , دانشگاه علوم بهزیستی و توانبخشی ،ساختمان فارابی ،طبقه دوم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2218 0092 Fax: Email: rd@uswr.ac.ir Web page address:
Protocol summary
Study aim
Determine to effect of dry needling on spasticity, consistency of corticospinal tract and function of upper extremity in subjects with stroke.
Design
A clinical trial, double-blind, placebo-controlled clinical trial will be performed
using sample of convenience and sample size of 10 individuals in each
group.
Settings and conduct
Dry needling will be performed using a sterilized, stainless, disposable nipple with a size of 0.25 mm 0.30 mm. Patients are in supine position,the arm is far from the trunk and elbow in supination . The technique used is fast in-fast out for each muscle for one minute.
Participants/Inclusion and exclusion criteria
Patients who 1) at least six month have passed since their stroke2) have had only one stroke 3) MMAS test is one to three, 3) Did not use any anti-spasticity medication 24 hours before of intervention will be included. People with dry needle contraindications, or any other neurological disease, or having a fixed muscle contraction in the wrist will be excluded.
Intervention groups
In the intervention group ( Dry needling): Wrist flexor muscles (flexor carpi ulnaris and flexor carpi radialis) were considered for needling . So patients undergo 3 sessions (every other day) deep needling for the affected wrist flexor muscles.
In control group( sham dry needling),Instead of dry needles, sham needles will be used for the same muscles as above. Sham needle has a thick edge that without irritating the skin only stimulates the skin.
Main outcome variables
The outcome measures include severity of spasticity by MMAS will be measurerd), consistency of CST which evaluated by DTI) and hand dexterity which will measured by BBT), and active and passive ROM that will be assessed by goniometer) before and after of treatment in both groups.
General information
Reason for update
Unfortunately, due to the corona pandemic, the start of data collecting of patient was delayed.
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045649N1
Registration date:2020-06-12, 1399/03/23
Registration timing:prospective
Last update:2021-06-19, 1400/03/29
Update count:2
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Masoome Ebrahimzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4435 3416
Email address
masoome.ebrahimzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-22, 1400/05/31
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Dry Needling on Spasticity, consistency of Corticospinal Tract and Function of Upper Extremity In Subject with Stroke
Public title
Effect Of Dry Needling on Spasticity, consistency of Corticospinal Tract and Function of Upper Extremity In Subject with Stroke
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
disease duration of at least six months
first ever stroke
wrist flexor MMAS spasticity score 1 up to 3
Taking no antispastic drug 24 hour before of the entrance to study
Exclusion criteria:
contraindications to Dry Needling
presence of any other neurological disorder
Fixed muscle contractures at the wrist joint
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment will be performed by a trained therapist. The evaluation is performed by another physiotherapist who is unaware of the grouping and treatment process of the patients. Patients will also be unaware of the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar dead, Daneshjoo Boulevard , Evin,
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.USWR.REC.1398.149
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Consistency corticospinal tract by fractional anisotropy value severity of spasticity
Timepoint
One day before the intervention and one day after the third intervention session
Method of measurement
Corticospinal tract imaging device OR Difussion tensor imaging MMAS
Secondary outcomes
1
Description
Wrist active ROM EXT Dexterity of hand
Timepoint
One day before intervention and on day after end of intervention
Method of measurement
Goniometer
2
Description
Wrist passive ROM EXT
Timepoint
One day before intervention and on day after end of intervention
Method of measurement
Goniometer
3
Description
Hand dexterity
Timepoint
One day before intervention and on day after end of intervention
Method of measurement
Box and Block test
Intervention groups
1
Description
Intervention group: The study included wrist flexor muscles (carpal ulnaris flexor and carpi radialis flexor). Patients underwent 3 sessions for (every other day) for deep wrist flexion of the affected wrist muscles. The technique used is fast in-fast out for each muscle for one minute.
Category
Rehabilitation
2
Description
Control group: Instead of dry needles, sham needles will be used for the same muscles as above. Sham needles have a thick edge that only irritates the skin without piercing the skin.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
National Brain Mapping Lab
Full name of responsible person
Mohamadreza Ay
Street address
South side of the Faculty of Electrical Engineering,Campus of Technical Schools,Kargar North Street,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8609 3109
Fax
+98 21 8609 3160
Email
info@nbml.ir
Web page address
https://nbml.ir/FA/pages/about
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr M ohamadreza khodaei ardakani
Street address
Second Floor,Farabi Building ,University of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0092
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoome ebrahimzadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Fifth Floor,Farabi Building ,University of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
Masoome.Ebrahimzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoome Ebrahimzadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Fifth Floor,Farabi Building ,University of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
Masoome.Ebrahimzadeh@Gmail.Com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoome Ebrahimzadeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Fifth Floor,Farabi Building ,University of Social Welfare and Rehabilitation Sciences,Koodakyar Impasse,Daneshjoo Blvd, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
Masoome.Ebrahimzadeh@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
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic data and primary and secondary out come measures can be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
any use of data must be in coordination with authors