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Effect of calf muscles dry needling on spasticity,knee and ankle range of motion and function in individuals with chronic stroke: A Randomized Controlled Trial

Protocol summary

Study aim
Determine the effects of dry needling (DN) on spasticity ,knee and ankle range of motion and function in individuals with chronic stroke
Design
A randomized, single-blind clinical trial with a parallel group design. The subjects are randomized with permuted block into two groups ( interventional and control)
Settings and conduct
Subjects are recruited from individuals with chronic stroke who refer to Shiraz School of Rehabilitation Sciences.The study is single-blinded and the assessor of MMAS, knee and ankle ROM and TUG test outcome is unaware of subjects allocation to the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: 6 months after a stroke involving cerebral cortical regions. first-ever unilateral stroke.ankle dorsi flexor MMAS spasticity score ≥ 2. able to ambulate without supportive device exclusion criteria:recurrent stroke. previous treatment with BTXA in the 6 months preceding the study.progressive or severe neurologic diseases, for example, heart conditions, unstable hypertension, fracture, or implants in the lower extremity.fear of needles.any contraindication for deep dry needling
Intervention groups
interventional group: rehabilitation exercises (strengthening exercise, PNF pattern and gait training), stretch of gastrocnemius, soleus and hip adductors muscles and DN over the gastrocnemius, soleus, tibialis anterior and hip adductors muscles on the spastic leg control group: rehabilitation exercises (strengthening exercise, PNF pattern and gait training) and stretch of gastrocnemius, soleus and hip adductors muscles
Main outcome variables
Modified Modified Ashworth Scale (MMAS); range of motion (ROM); Timed up and go (TUG) test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091130002793N5
Registration date: 2019-09-10, 1398/06/19
Registration timing: registered_while_recruiting

Last update: 2019-09-10, 1398/06/19
Update count: 0
Registration date
2019-09-10, 1398/06/19
Registrant information
Name
Shahla Zahednejad
Name of organization / entity
School Of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3102
Email address
snejad@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-18, 1398/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of calf muscles dry needling on spasticity,knee and ankle range of motion and function in individuals with chronic stroke: A Randomized Controlled Trial
Public title
Effect of dry needling on spasticity in individuals with chronic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 months after a stroke involving cerebral cortical regions first-ever unilateral stroke ankle dorsi flexor MMAS spasticity score ≥2 able to ambulate without supportive device
Exclusion criteria:
recurrent stroke previous treatment with BTXA in the 6 months preceding the study progressive or severe neurologic diseases, for example, heart conditions, unstable hypertension, fracture, or implants in the lower extremity fear to needles any contraindication for deep dry needling
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization Randomization was achieved with an online randomization application to provide random permuted blocks with an block size of 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor of MMAS, knee and ankle ROM and TUG test outcome was unaware of subjects allocation to the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Ahwaz Jundishapour University of Medical Sciences, Golestan St,Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
7194714315
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.AJUMS.REC.1397.812

Health conditions studied

1

Description of health condition studied
spasticity, knee and ankle range of motion and function in individuals with chronic stroke
ICD-10 code
G81.1
ICD-10 code description
Spastic hemiplegia

Primary outcomes

1

Description
spasticity
Timepoint
before intervention, 3 weeks after first session, immediately after last session and 1 week after last session
Method of measurement
Modified Modified Ashworth Scale

Secondary outcomes

1

Description
knee range of motion
Timepoint
before intervention, 3 weeks after first session, immediately after last session and 1 week after last session
Method of measurement
protractor

2

Description
ankle range of motion
Timepoint
before intervention, 3 weeks after first session, immediately after last session and 1 week after last session
Method of measurement
protractor

3

Description
Functional activity
Timepoint
before intervention, 3 weeks after first session, immediately after last session and 1 week after last session
Method of measurement
Timed Up and Go test

Intervention groups

1

Description
Intervention group:This group will receive rehabilitation exercises (strengthening exercises, PNF pattern and gait training)and stretch of gastrocnemius, soleus and hip adductors muscles for 6 weeks and 2 sessions in each week. Dry needling will apply over gastrocnemius, soleus, tibialis anterior and hip adductors muscles on the spastic leg if necessary.
Category
Treatment - Other

2

Description
Control group: This group will receive rehabilitation exercises (strengthening exercises, PNF pattern and gait training)and stretch of gastrocnemius, soleus and hip adductors muscles for 6 weeks and 2 sessions in each week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation Sciences
Full name of responsible person
Leila Abbasi
Street address
Abiverdi 1 St, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan St., Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
Badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Zahednejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research center,School Of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3102
Fax
+98 61 3374 3506
Email
snejad@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Zahednejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research center,School Of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahwaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3102
Fax
+98 61 3374 3506
Email
snejad@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahla Zahednejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research center,School Of Rehabilitation Sciences, Ahvaz Jundishapur
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3102
Fax
+98 61 3374 3506
Email
snejad@ajums.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
The data of the participant alone is useless.
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of primary outcomes will be shared.
When the data will become available and for how long
two months after the publication of the results.
To whom data/document is available
academic researchers
Under which criteria data/document could be used
Once accessed, individuals have the right to use the study protocol for rehabilitation purposes.
From where data/document is obtainable
Atousa Ebrahimi will be responsive through email. atousa192@yahoo.com
What processes are involved for a request to access data/document
After receiving the request and mentioning the reasons for the request, the data will be answered within a maximum of one month.
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