Comparison of the effect of dry needling with and without exercise therapy on wrist flexors spasticity, motor function and motor neuron excitability in patients with chronic stroke: a double-blind randomized clinical trial
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Protocol summary
A double-blind randomized clinical trial with parallel groups and three-week follow-up.
Randomization is done by throwing coins.
Sample size was 12 patients in each groups according to the results of similar studies using G power software.
A double-blind randomized clinical trial with parallel groups and three-week follow-up.
Randomization will be done by selecting the opaque envelopes.
The sample size was 12 patients in each group according to the results of similar studies using G power software.
A double-blind randomized clinical trial with parallel groups and three-week follow-up. Randomization iswill be done by throwing coinsselecting the opaque envelopes. SampleThe sample size was 12 patients in each groupsgroup according to the results of similar studies using G power software.
کارآزمایی بالینی تصادفی دو سو کور با گروه های موازی و پیگیری سه هفته ای.
تصادفی سازی با پرتاب سکه انجام می شود.
حجم نمونه با توجه به نتایج مطالعات مشابه و با استفاده از نرم افزار G power در هر گروه 12 نفر به دست آمد.
کارآزمایی بالینی تصادفی دو سو کور با گروه های موازی و پیگیری سه هفته ای.
تصادفی سازی با انتخاب پاکت در بسته انجام خواهد شد.
حجم نمونه با توجه به نتایج مطالعات مشابه و با استفاده از نرم افزار G power در هر گروه 12 نفر به دست آمد.
کارآزمایی بالینی تصادفی دو سو کور با گروه های موازی و پیگیری سه هفته ای. تصادفی سازی با پرتاب سکهانتخاب پاکت در بسته انجام می شودخواهد شد. حجم نمونه با توجه به نتایج مطالعات مشابه و با استفاده از نرم افزار G power در هر گروه 12 نفر به دست آمد.
General information
2021-05-20, 1400/02/30
2021-12-21, 1400/09/30
2021-0512-2021 00:00:00
Because of the Covid pandemic, sampeling will take a longe time.
Because of the Covid pandemic, sampling will take a long time, and the study time will take longer.
In the abstract (study design) section, the randomization method was entered incorrectly and corrected.
The "motor function" criterion was entered from the primary outcome measure section into the secondary outcome measure section.
Because of the Covid pandemic, sampelingsampling will take a longelong time, and the study time will take longer. In the abstract (study design) section, the randomization method was entered incorrectly and corrected. The "motor function" criterion was entered from the primary outcome measure section into the secondary outcome measure section.
به دلیل شیوع بیماری کرونا نمونه گیری طولانی تر خواهد شد.
به دلیل شیوع بیماری کرونا نمونه گیری طولانی تر گردیده و زمان انجام مطالعه بیشتر طول خواهد کشید .
در بخش چکیده (طراحی مطالعه) روش تصادفی سازی به اشتباه وارد شده بود که اصلاح گردید.
معیار "عملکرد حرکتی " از بخش معیار پیامد اولیه وارد بخش معیار پیامد ثانویه گردید.
به دلیل شیوع بیماری کرونا نمونه گیری طولانی تر گردیده و زمان انجام مطالعه بیشتر طول خواهد شدکشید . در بخش چکیده (طراحی مطالعه) روش تصادفی سازی به اشتباه وارد شده بود که اصلاح گردید. معیار "عملکرد حرکتی " از بخش معیار پیامد اولیه وارد بخش معیار پیامد ثانویه گردید.
Primary outcomes
#1
Motor function
empty
Motor function
عملکرد حرکتی
empty
عملکرد حرکتی
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
empty
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
قبل و پس از انجام مداخله (4هفته بعد) و 3هفته پس از اتمام مداخله
empty
قبل و پس از انجام مداخله (4هفته بعد) و 3هفته پس از اتمام مداخله
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
empty
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
مطالعه عملکرد حرکتی بیماران با تست های Fugl-Meyer Scale و Action Research Arm Test
empty
مطالعه عملکرد حرکتی بیماران با تست های Fugl-Meyer Scale و Action Research Arm Test
Secondary outcomes
#1
empty
Motor function
Motor function
empty
عملکرد حرکتی
عملکرد حرکتی
empty
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
empty
قبل و پس از انجام مداخله (4هفته بعد) و 3هفته پس از اتمام مداخله
قبل و پس از انجام مداخله (4هفته بعد) و 3هفته پس از اتمام مداخله
empty
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
empty
مطالعه عملکرد حرکتی بیماران با تست های Fugl-Meyer Scale و Action Research Arm Test
مطالعه عملکرد حرکتی بیماران با تست های Fugl-Meyer Scale و Action Research Arm Test
Recruitment centers
#1
Name of recruitment center - English: Shafa Yahyaian hospital
Name of recruitment center - Persian: بیمارستان شفا یحیاییان
Full name of responsible person - English: Seyed Abbas Motavalian
Full name of responsible person - Persian: سید عباس متولیان
Street address - English: Shafa Yahyaian hospital, Mojahedin-e-Islami Street, Baharestan Square
Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام، بیمارستان شفایحیائیان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۶۶۵-۳۵۴
Phone: +98 21 8670 2503
Fax:
Email: research@iums.ac.ir
Web page address: https://www.drsosha.com/مراکز-درمانی/شفایحیاییان-تامین-اجتماعی/
Name of recruitment center - English: Shafa Yahyaian hospital
Name of recruitment center - Persian: بیمارستان شفا یحیاییان
Full name of responsible person - English: Seyed Abbas Motavalian
Full name of responsible person - Persian: سید عباس متولیان
Street address - English: Shafa Yahyaian hospital, Mojahedin-e-Islami Street, Baharestan Square
Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام، بیمارستان شفایحیائیان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14665-354
Phone: +98 21 8670 2503
Fax:
Email: research@iums.ac.ir
Web page address: https://www.drsosha.com/مراکز-درمانی/شفایحیاییان-تامین-اجتماعی/
Name of recruitment center - English: Shafa Yahyaian hospital Name of recruitment center - Persian: بیمارستان شفا یحیاییان Full name of responsible person - English: Seyed Abbas Motavalian Full name of responsible person - Persian: سید عباس متولیان Street address - English: Shafa Yahyaian hospital, Mojahedin-e-Islami Street, Baharestan Square Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام، بیمارستان شفایحیائیان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۶۶۵14665-۳۵۴354 Phone: +98 21 8670 2503 Fax: Email: research@iums.ac.ir Web page address: https://www.drsosha.com/مراکز-درمانی/شفایحیاییان-تامین-اجتماعی/
Protocol summary
Study aim
The purpose of this study was to compare the effect of dry needle with and without exercise therapy on wrist flexor spasticity, motor function and motor neuron excitability in patients with chronic stroke.
Design
A double-blind randomized clinical trial with parallel groups and three-week follow-up.
Randomization will be done by selecting the opaque envelopes.
The sample size was 12 patients in each group according to the results of similar studies using G power software.
Settings and conduct
Patients who meet the inclusion criteria will be recalled from neurosurgery clinics. After initial evaluations, patients will be randomly assigned to the control and treatment groups by the coining a toss. The treatment group will receive the dry needle with the exercise therapy and the control group only receive dry needle. Treatment will be performed once a week for 4 weeks and assessments are performed again after 4 weeks as well as after a 3-week follow-up. One experienced physiotherapist will perform the assessments and the other will perform evaluation. Patients did not know whether they are in the intervention or in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Documented diagnosis of stroke by a neurologist;
At least 6 months have passed since the stroke;
Age range of 40 to 65 years;
being the first time stroke leading to hemiplegia;
Spasticity greater than one for wrist flexor muscles based on MMAS scale.
Exclusion criteria:
Having contracture in hand;
Contraindication for dry needling
Intervention groups
Intervention group: Dry needling with exercise therapy. 4 sessions exercise therapy after dry needle (onse a week)
Control group: Dry needling. 4 sessions dry neddling (once a week)
Main outcome variables
Wrist flexor spasticity; motor neuron excitability; motor function; wrist extension range of motion
General information
Reason for update
Because of the Covid pandemic, sampling will take a long time, and the study time will take longer.
In the abstract (study design) section, the randomization method was entered incorrectly and corrected.
The "motor function" criterion was entered from the primary outcome measure section into the secondary outcome measure section.
Acronym
IRCT registration information
IRCT registration number:IRCT20180611040061N1
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2021-07-11, 1400/04/20
Update count:4
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Seyedeh Saeideh Babazadeh-Zavieh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 1431
Email address
babazadehpt89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dry needling with and without exercise therapy on wrist flexors spasticity, motor function and motor neuron excitability in patients with chronic stroke: a double-blind randomized clinical trial
Public title
Effect of dry needling with exercise therapy on stroke spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Documented diagnosis of stroke by a neurologist
At least 6 months have passed since the stroke
Age>40 years
Being the first time stroke leading to hemiplegia
Spasticity greater than one for wrist flexor muscles based on MMAS scale
Absence of sensory disorders, bleeding, upper limb malignancies, ulcers and infection
Ability to understand therapist and evaluator instructions
Full consent to participate in the research
Exclusion criteria:
Fear of applying dry needles
Having contracture in hand
Contraindication for dry needling
Other neurological lesions
Having Diabetes
Any history of treatment with nerve blockers such as botulinum toxin A 6 months prior to inclusion
Age
From 40 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
In order to randomly assign the patients, the opaque envelopes will be prepared containing the assigned terms "dry needling" or "dry needling+ exercise therapy" interventions. The therapist will be choosing an envelope randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind clinical trial in which a expert physiotherapist will perform intervention and other physiotherapists will perform the Assessment. As a result, the Assessor will not know which group the patient belongs to.
On the other hand, by giving a separate questionnaire to each patient in two groups, they will not know whether they are in the intervention group or in the control group.
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
School of Rehabilitation Sciences, Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.TUMS.FNM.REC.1399.008
Health conditions studied
1
Description of health condition studied
Chronic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Wrist flexors spasticity
Timepoint
Measurement of Spasticity before and after the intervention (4 weeks after intervention) and 3 weeks after the intervention
Method of measurement
Persian version of Modified Modified Ashworth Scale
2
Description
Alpha motor neuron excitability
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Electromyography machine (EMG)
Secondary outcomes
1
Description
Range of motion
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Goniometer
2
Description
Motor function
Timepoint
Before and after intervention (4 weeks after intervention) and 3 weeks after intervention
Method of measurement
Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test
Intervention groups
1
Description
Intervention group: In the treatment group, patients will receive exercise therapy in addition to dry needle. Immediately after dry needle, patients will do exercises in Structure, Function, and Activity levels to mobilize wrist and finger joints to relieve muscle strength imbalance and gain motor control of affected limb and improve performance for 30 to 45 minutes, once a week, for a total of 4 weeks. The same exercises will be performed once a day at home and if they are unable to fully perform each exercise, the therapist in the clinic and a person at home will help the patients.
Category
Rehabilitation
2
Description
Control group: The control group will only receive dry needle intervention. Dry needle treatment will be administered once a week for 4 weeks. Patients in this group will continue their previous activities throughout life without any changes.