Protocol summary

Study aim
Comparing the effect of one session with three sessions per week of dry needling in reducing spasticity and improving motor function of stroke patients and determining the number of more effective treatment sessions per week.
Design
Randomized;single blind ;simple randomized controlled clinical trial was performed on 24 patients for manual randomization with random selection of evaluation sheets.
Settings and conduct
Arman Pouya Isfahan Physiotherapy, dry needling in ulnar and radial wrist flexor muscles in one session and three sessions per week, the evaluator has been blinded to the first and second groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, first experience of stroke, stroke hemiplegia, at least six months after stroke, spasticity in wrist flexor muscles, not taking any antispasmodics, ability to understand instructions Exclusion criteria: Contraindication of dry needle use, diabetes, any other neurological complication, cervical radiculopathy, fixed contractures in the wrist area, receiving other treatments at the same time, fear of dry needle, Botox injection To reduce spasticity over the past six months
Intervention groups
Participants are randomly divided into two groups. The group receives one session per week and the group three sessions per week for dry needling. The dry acupuncture technique is performed for the ulnar and radial flexor muscles of patients with a conical method and for a maximum of one minute for each point.
Main outcome variables
Active range of motion; Passive range of motion; Passive resistive torque; Severity of spasticity; Bronstrom recovery stage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210116050047N1
Registration date: 2021-02-22, 1399/12/04
Registration timing: prospective

Last update: 2021-02-22, 1399/12/04
Update count: 0
Registration date
2021-02-22, 1399/12/04
Registrant information
Name
Fatemeh Alsadat Hasheminasab Zavareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5437 6410
Email address
f-hasheminasab@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of one session vs three sessions of dry needling on wrist flexor muscles spasticity and motor function in patients with stroke
Public title
Evaluation of the effect of dry needling in reducing wrist stiffness and improving motor function in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years The first experience of a stroke Stroke-induced hemiplegia At least six months have passed since the stroke Spasticity in the flexor muscles of the wrist Do not take any antispasmodics Ability to understand instructions
Exclusion criteria:
contraindication of dry needles (such as anticoagulants, infections, bleeding) Diabetes Existence of any other neurological complication Cervical radiculopathy Fixed contractures in the wrist area Receive other treatments at the same time Fear of dry needles Botox injections to reduce spasticity during the last six months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random Russian is used to determine the research groups. First, a sheet is prepared in the specified number of samples, and on half of the sheets, the group writes one session in a week of dry needling and the other half of the group writes three sessions in a week of dry needling. The order of these sheets is distorted and when the samples are referred, one sheet is randomly removed for each person and the relevant group is determined based on the registered title. The evaluator performs the clinical tests in random order and completes the evaluation and is completely blind to the first and second groups. The therapist is another experienced physiotherapist who is fully trained to perform dry needling and performs the treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-way blind study, the evaluator performs clinical tests in random order and completes the evaluation and is completely blind to the first and second groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
First Alley, Post Alley, 11 Khordad St., Mosalla Square
City
Zavareh
Province
Isfehan
Postal code
8441817716
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.158

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Passive resistive torque
Timepoint
Before the intervention, after the end of the intervention, one week after the end of the intervention
Method of measurement
Hand held dynamometer

Secondary outcomes

1

Description
Spasticity
Timepoint
Before intervention, after intervention, one week after intervention
Method of measurement
Modified Modified Ashworth Scale

2

Description
Bronstrom recovery stage
Timepoint
Before intervention, after intervention, one week after intervention
Method of measurement
Six-stage system of patients' motor recovery

3

Description
Active range of motion of the wrist
Timepoint
Before intervention, after intervention, one week after intervention
Method of measurement
Goniometer

4

Description
Passive range of motion of the wrist
Timepoint
Before intervention, after intervention, one week after intervention
Method of measurement
Goniometer

Intervention groups

1

Description
Intervention group: Three sessions of dry needling per week on the ulnar and radial flexor muscles of the wrist
Category
Treatment - Devices

2

Description
Control group: One dry needling session per week on the ulnar and radial flexor muscles of the wrist
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Arman Pouya Physiotherapy Clinic
Full name of responsible person
Fatemeh Alsadat Hasheminasab Zavareh
Street address
Arman Pouya Physiotherapy Clinic, not far from Mosalla Square, Ayatollah Taleghani St., Vahdat Square
City
Zavareh
Province
Isfehan
Postal code
8441817716
Phone
+98 31 5437 6410
Email
fhz1373@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
MOHAMMAD ALI SAHRAIAN
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Central University Organization, Corner of Ghods St., Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 6670 6142
Fax
Email
msahrai@tums.ac.ir
Grant name
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
Fatemeh Alsadat Hasheminasab Zavareh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
First Alley, Post Alley, 11 Khordad St., Mosalla Square
City
Zavareh
Province
Isfehan
Postal code
8441817716
Phone
+98 31 5437 6410
Email
fhz1373@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Alsadat Hasheminasab Zavareh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
First Alley, Post Coupe, 11 Khordad St., Mosalla Square
City
Zavareh
Province
Isfehan
Postal code
8441817716
Phone
+98 31 5437 6410
Fax
Email
f-hasheminasab@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Alsadat Hasheminasab Zavareh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
First Alley, Post Coupe, 11 Khordad St., Mosalla Square
City
Zavareh
Province
Isfehan
Postal code
8441817716
Phone
+98 31 5437 6410
Fax
Email
f-hasheminasab@razi.tums.ac.ir

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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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